Trial Outcomes & Findings for User-Led Meaningful Activity and Early-Stage Dementia (NCT NCT05159869)
NCT ID: NCT05159869
Last Updated: 2026-01-12
Results Overview
Global cognitive function will be measured by the Wechsler Memory Scale-III (WMS-III) information/orientation subtest, which assesses general personal information and orientation to person, place, and time. Scores range from 0-14, with higher scores indicating more intact global cognitive function. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean.
COMPLETED
NA
61 participants
Baseline and 4 months
2026-01-12
Participant Flow
31 participants with dementia were randomized to the Experimental Group. One of the participants was enrolled to account for possible attrition. 30 Waitlist participants were enrolled. One caregiver (not enrolled) per participant assisted participants in modifying meaningful activities as needed, in accordance with the co-designed plan, based on dementia progression.
Participant milestones
| Measure |
Experimental Group - Individuals With Dementia
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be administered at six months. The neuropsychological battery that was administered at baseline will be re-administered four months and 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Wait-List Control Group - Individuals With Dementia
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time. The neuropsychological battery administered at baseline will be readministered after four and 12 months.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
|
Overall Study
Caregivers (Not Enrolled)
|
31
|
30
|
|
Overall Study
Individuals With Dementia
|
31
|
30
|
|
Overall Study
COMPLETED
|
31
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
User-Led Meaningful Activity and Early-Stage Dementia
Baseline characteristics by cohort
| Measure |
Experimental
n=31 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Wait-List Control
n=30 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
79.76 years
STANDARD_DEVIATION 7.028 • n=210 Participants
|
80.30 years
STANDARD_DEVIATION 6.132 • n=19 Participants
|
79.99 years
STANDARD_DEVIATION 6.624 • n=8 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=210 Participants
|
16 Participants
n=19 Participants
|
33 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=210 Participants
|
14 Participants
n=19 Participants
|
28 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
19 Participants
n=210 Participants
|
20 Participants
n=19 Participants
|
39 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White, Hispanic
|
1 Participants
n=210 Participants
|
2 Participants
n=19 Participants
|
3 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black
|
7 Participants
n=210 Participants
|
3 Participants
n=19 Participants
|
10 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=210 Participants
|
3 Participants
n=19 Participants
|
5 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
2 Participants
n=210 Participants
|
2 Participants
n=19 Participants
|
4 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
31 Participants
n=210 Participants
|
30 Participants
n=19 Participants
|
61 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 monthsGlobal cognitive function will be measured by the Wechsler Memory Scale-III (WMS-III) information/orientation subtest, which assesses general personal information and orientation to person, place, and time. Scores range from 0-14, with higher scores indicating more intact global cognitive function. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean.
Outcome measures
| Measure |
Experimental
n=31 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Wait-List Control
n=30 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
|---|---|---|
|
Change in Global Cognitive Function as Assessed by the Wechsler Memory Scale-III
|
-0.2 score on a scale
Standard Deviation 0.8
|
-0.2 score on a scale
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: Baseline and 4 monthsAttention will be assessed via the Wechsler Adult Intelligence Scale (WAIS-IV) digit span subtest total score, obtained by adding up the total score on Digit Span Forward, Digit Span Backward, and Digit Span Sequencing. For all 3 tests, range = 0-16, with higher scores indicating better attention. Total raw score range = 0-48. Every series on each digit span subtest consists of two trials, each of which is scored 1 or 0 points. Testing is discontinued when a zero is obtained on both trials of an item. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean.
Outcome measures
| Measure |
Experimental
n=31 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Wait-List Control
n=30 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
|---|---|---|
|
Change in the Cognitive Domain of Attention as Assessed by the Wechsler Adult Intelligence Scale-IV Digit Span Test
|
0.6 score on a scale
Standard Error 0.3
|
-0.2 score on a scale
Standard Error 0.3
|
PRIMARY outcome
Timeframe: Baseline and 4 monthsProcessing speed will be assessed via the Trail-Making Test Part A. Participants must draw lines connecting 25 numbered circles in sequential order within a maximum time of 150 seconds. The raw completion time in seconds is converted to age-normed T-scores to facilitate standardized interpretation. Lower T-scores indicate slower processing speed, whereas higher T-scores indicate faster processing speed. Regarding clinically relevant thresholds, T-scores are standardized scores with a mean of 50 and a standard deviation (SD) of 10. A T-score below 40 (i.e., 1 SD below the mean) may suggest mild impairment in processing speed. T-scores below 30 (i.e., 2 SDs below the mean) may reflect substantial processing speed dysfunction. T-scores above 60 reflect performance that is above average for the individual's normative peer group. The outcome is measured as a change in T-score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean.
Outcome measures
| Measure |
Experimental
n=31 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Wait-List Control
n=30 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
|---|---|---|
|
Change in the Cognitive Domain of Processing Speed as Assessed by the Trail-Making Test Part A
|
2.6 T-score
Standard Deviation 6.4
|
-0.2 T-score
Standard Deviation 6.7
|
PRIMARY outcome
Timeframe: Baseline and 4 monthsExecutive function will be assessed via the Trail-Making Test Part B. Participants must draw lines connecting 13 numbered circles alternately with 12 letters of the alphabet, all in ascending order within a maximum time of 300 seconds. The raw completion time in seconds is converted to age-normed T-scores. Lower T-scores indicate potential deficits in executive function, and higher T-scores indicate more intact executive function. For clinically relevant thresholds, T-scores are standardized scores with a mean of 50 and a standard deviation (SD) of 10. A T-score below 40 (i.e., 1 SD below the mean) may suggest mild executive dysfunction. T-scores below 30 (i.e., 2 SDs below the mean) may reflect substantial executive dysfunction. T-scores above 60 reflect above average executive function for the individual's normative peer group. The outcome is measured as a change in T-score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates improvement in the group mean.
Outcome measures
| Measure |
Experimental
n=31 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Wait-List Control
n=30 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
|---|---|---|
|
Change in the Cognitive Domain of Executive Function as Assessed by the Trail-Making Test Part B
|
2.7 T-score
Standard Deviation 7.6
|
-0.6 T-score
Standard Deviation 7.2
|
PRIMARY outcome
Timeframe: Baseline and 4 monthsExecutive function will be assessed via the Stroop Color-Word Test, a 100-item word-color page where word meanings and ink colors are mismatched (score range = 0-100). The participant must name as many correct ink colors as possible within a time limit of 45 seconds. The number of items correctly named is the raw score, which is converted to a T-score based on normative data, with higher T-scores indicating better executive function. For clinically relevant thresholds, T-scores are standardized scores with a mean of 50 and a standard deviation (SD) of 10. A T-score below 40 (i.e., 1 SD below the mean) suggests mild executive dysfunction. T-scores below 30 (i.e., 2 SDs below the mean) suggests substantial executive dysfunction. T-scores above 60 reflect above average executive function for the individual's normative peer group. The outcome is measured as a change in T-score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean.
Outcome measures
| Measure |
Experimental
n=31 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Wait-List Control
n=30 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
|---|---|---|
|
Change in the Cognitive Domain of Executive Function as Assessed by the Stroop Color-Word Test
|
1.1 T-score
Standard Deviation 6.9
|
0.4 T-score
Standard Deviation 5.8
|
PRIMARY outcome
Timeframe: Baseline and 4 monthsExecutive function will be assessed via the Clock Drawing Test Part 1 (CLOX 1). Participants will be asked to draw a clock, put in all the numbers, and set the hands to a specific time. The results will be scored using the CLOX method, which specifically evaluates executive function. CLOX1 scores range from 0-15. Lower scores reflect greater impairment. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean.
Outcome measures
| Measure |
Experimental
n=31 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Wait-List Control
n=30 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
|---|---|---|
|
Change in the Cognitive Domain of Executive Function as Assessed by the Clock Drawing Test (CLOX1)
|
1.3 units on a scale
Standard Deviation 1.9
|
0.2 units on a scale
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: Baseline and 4 monthsImmediate memory and new learning will be assessed via the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtest of List Learning. In list learning, 10 semantically unrelated words are orally presented to the subject at a two-second rate. The subject is asked to repeat as many words as possible after each of four learning trials. A higher number of words recalled (range 0-40) indicate more intact immediate memory. Raw scores are converted to a scaled score and percentile rank based on normative data. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean.
Outcome measures
| Measure |
Experimental
n=31 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Wait-List Control
n=30 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
|---|---|---|
|
Change in the Cognitive Domain of Immediate Memory and Learning as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status List Learning Subtest
|
2.7 units on a scale
Standard Deviation 4.6
|
0.1 units on a scale
Standard Deviation 4.4
|
PRIMARY outcome
Timeframe: Baseline and 4 monthsMemory and new learning will be assessed via the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtest Story Memory. Story Memory is a twelve-item short story presented over two trials (score range: 0-24). The story is read aloud at a slow reading speed. After each presentation, the subject is asked to recall as much of the story as he or she can remember, with more items recalled indicating more intact immediate memory. A verbatim criterion is used. Raw scores are converted to a scaled score and percentile rank based on normative data. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean.
Outcome measures
| Measure |
Experimental
n=31 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Wait-List Control
n=30 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
|---|---|---|
|
Change in the Cognitive Domains of Memory and Learning as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Story Memory Subtest
|
1.8 units on a scale
Standard Deviation 3.4
|
0.3 units on a scale
Standard Deviation 3.2
|
PRIMARY outcome
Timeframe: Baseline and 4 monthsPopulation: Participants with data collected
Delayed memory will be assessed via the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtest of List Recall. List Recall requires the participant to remember as many words (range 0-10) from the list learning test as possible after a delay, with a higher number of words recalled indicating more intact delayed recall. Raw scores are converted to a scaled score and percentile rank based on normative data. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean.
Outcome measures
| Measure |
Experimental
n=31 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Wait-List Control
n=30 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
|---|---|---|
|
Change in the Cognitive Domain of Delayed Memory as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status List Recall Subtest
|
1.2 units on a scale
Standard Deviation 2.0
|
0.2 units on a scale
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Baseline and 4 monthsDelayed memory will be assessed via the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtest of List Recognition. After the List Learning and List Recall tasks (immediate and delayed), the participant is presented with a series of yes/no recognition trials including target words from the original list and foils. One point is awarded for each correct yes/no answer (range = 0-20), with a higher number of words recognized indicating more intact delayed recall. Raw scores are converted to a scaled score and percentile rank based on normative data. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean.
Outcome measures
| Measure |
Experimental
n=31 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Wait-List Control
n=30 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
|---|---|---|
|
Change in the Cognitive Domain of Delayed Memory as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status List Recognition Subtest
|
1.1 units on a scale
Standard Deviation 2.3
|
0.2 units on a scale
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: Baseline and 4 monthsDelayed memory will be assessed via the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtest of Story Recall. In Story Recall, participants are asked to recall as many specific details as possible from the story learned in the story memory subtest, with more details indicating more intact delayed recall. Raw scores are converted to a scaled score and percentile rank based on normative data. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean.
Outcome measures
| Measure |
Experimental
n=31 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Wait-List Control
n=30 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
|---|---|---|
|
Change in the Cognitive Domain of Delayed Memory as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Story Memory Subtest
|
1.4 units on a scale
Standard Deviation 3.3
|
0.3 units on a scale
Standard Deviation 3.2
|
PRIMARY outcome
Timeframe: Baseline and 4 monthsImmediate visual (non-verbal) memory will be assessed via the Rey-Osterrieth Complex Figure (ROCF) test. Participants will first copy a complex geometric figure and then immediately reproduce it from memory. Scoring of drawings is based on the widely used 36-point scoring system, with higher scores indicating more intact immediate visual memory. Each of the 18 scoring units is scored based on accuracy and placement criteria. Raw scores are converted to a scaled score and percentile rank based on normative data. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean.
Outcome measures
| Measure |
Experimental
n=31 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Wait-List Control
n=30 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
|---|---|---|
|
Change in the Cognitive Domain of Immediate Visual Memory as Assessed by the Rey-Osterrieth Complex Figure Test
|
1.7 units on a scale
Standard Deviation 3.8
|
0.4 units on a scale
Standard Deviation 3.9
|
PRIMARY outcome
Timeframe: Baseline and 4 monthsDelayed visual (non-verbal) memory will be assessed via the Rey-Osterrieth Complex Figure (ROCF) test. Participants are asked to draw all the elements of the figure from the initial figure copy that he or she can recall without visual display of the figure. Scoring of drawings is based on the widely used 0-36-point scoring system (score range), with higher scores indicating more intact delayed visual memory. Each of the 18 scoring units is scored based on accuracy and placement criteria. Raw scores are converted to a scaled score and percentile rank based on normative data. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean.
Outcome measures
| Measure |
Experimental
n=31 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Wait-List Control
n=30 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
|---|---|---|
|
Change in the Cognitive Domain of Delayed Visual Memory as Assessed by the Rey-Osterrieth Complex Figure Test
|
0.9 units on a scale
Standard Deviation 3.4
|
0.2 units on a scale
Standard Deviation 3.5
|
PRIMARY outcome
Timeframe: Baseline and 4 monthsLanguage, specifically verbal fluency, will be assessed via the Controlled Oral Word Association (COWA) test. Participants are asked to come up with as many words as possible that begin with a given letter within a one-minute time period. Participants are also instructed to exclude proper nouns, numbers, and the same word with a different suffix. Score range 0-36. The number of correct responses is totaled, with higher numbers indicating greater verbal fluency, and the sum compared with normative data. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean.
Outcome measures
| Measure |
Experimental
n=31 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Wait-List Control
n=30 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
|---|---|---|
|
Change in the Cognitive Domain of Language as Assessed by the Controlled Oral Word Association Test
|
2.5 units on a scale
Standard Deviation 4.3
|
0.4 units on a scale
Standard Deviation 4.4
|
PRIMARY outcome
Timeframe: Baseline and 4 monthsLanguage will be assessed via the Boston Naming Test (BNT). Participants are asked to name 60 line drawings of objects of graded difficulty, ranging from very common objects to less familiar ones. Objects must be spontaneously named within a 20-second period. If time limit expires, two kinds of prompting cues (one phonemic, one semantic) may be given. Rules allow for discontinuation and for starting the test at an advanced level, thus saving considerable time for subjects without obvious impairment. The examiner will then total the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. Score range 0-60. A higher number of correct spontaneous responses indicates more intact language skills. Scores will be compared to normative data. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean.
Outcome measures
| Measure |
Experimental
n=31 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Wait-List Control
n=30 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
|---|---|---|
|
Change in the Cognitive Domain of Language as Assessed by the Boston Naming Test
|
2.1 units on a scale
Standard Deviation 3.8
|
0.6 units on a scale
Standard Deviation 3.9
|
PRIMARY outcome
Timeframe: Baseline and 4 monthsLanguage will be assessed via the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) semantic fluency subtest. This test involves the generation of as many unique examples as possible from a given semantic category within 60 seconds. Raw scores typically range from 0 to approximately 30-40, depending on age and clinical status, with higher scores indicating better performance (i.e., greater language fluency and semantic access). The outcome is reported as a change in group mean T2 (4 months) - T1 (baseline), where the raw score is defined as the total number of valid, non-redundant examples generated on the RBANS Semantic Fluency subtest. A positive value indicates improved semantic fluency.
Outcome measures
| Measure |
Experimental
n=31 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Wait-List Control
n=30 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
|---|---|---|
|
Change in the Cognitive Domain of Language as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Semantic Fluency
|
1.5 examples
Standard Deviation 3.4
|
0.5 examples
Standard Deviation 3.2
|
PRIMARY outcome
Timeframe: Baseline and 4 monthsVisuospatial constructional ability is assessed using the Rey-Osterrieth Complex Figure (ROCF) test, a neuropsychological task in which participants reproduce a complex geometric figure. Scoring uses the standard 36-point system, in which 18 components are rated for accuracy and placement (0-2 points each). The total raw score ranges from 0 to 36, with higher scores indicating better performance. The outcome is reported as a change in mean raw score from baseline (T1) to 4 months (T2). A positive change score reflects improvement in visuospatial constructional ability.
Outcome measures
| Measure |
Experimental
n=31 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Wait-List Control
n=30 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
|---|---|---|
|
Change in the Cognitive Domain of Visuospatial Constructional Ability as Assessed by the Rey-Osterrieth Complex Figure Test
|
1.1 points
Standard Deviation 2.9
|
0.2 points
Standard Deviation 2.9
|
PRIMARY outcome
Timeframe: Baseline and 4 monthsFrequency and severity of neuropsychiatric symptoms are measured by the Neuropsychiatric Inventory (NPI) as reported by the primary caregiver. The NPI is a retrospective interview covering 12 neuropsychiatric symptom domains and is used to evaluate psychopathology, neuropsychiatric manifestations, and caregiver distress. Each NPI domain is rated by the caregiver for symptom frequency and severity. Symptom frequency is rated as 1 = occasionally, 2 = often, 3 = frequently, 4 = very frequently. Symptom severity is rated as 1= mild, 2 = moderate, 3 = marked. The total score is calculated as a sum of all 12 domain scores and thus ranges from 12 to 144, with a higher score indicating worsening symptoms. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a negative mean indicates an improvement in frequency x severity of symptoms.
Outcome measures
| Measure |
Experimental
n=31 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Wait-List Control
n=30 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
|---|---|---|
|
Change in the Frequency x Severity of Neuropsychiatric Symptoms in Persons With Dementia as Assessed by the Neuropsychiatric Inventory (NPI)
|
-4.4 score on a scale
Standard Deviation 7.32
|
-1.0 score on a scale
Standard Deviation 7.9
|
PRIMARY outcome
Timeframe: Baseline and 4 monthsVisuospatial ability is assessed using the Line Orientation subtest of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). In this task, participants are asked to match two angled lines to corresponding lines from a semicircular fan of 13 lines. The test includes 10 trials, and each correct match is awarded 2 points, for a total raw score range of 0 to 20. Higher scores indicate better visuospatial performance. The outcome is reported as a change in mean raw score from baseline (T1) to 4 months (T2). A positive score reflects improved visuospatial ability.
Outcome measures
| Measure |
Experimental
n=31 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Wait-List Control
n=30 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
|---|---|---|
|
Change in the Cognitive Domain of Visuospatial Ability as Assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Line Orientation
|
0.4 points
Standard Deviation 2.1
|
0.2 points
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Baseline and 4 monthsDepression in persons with dementia will be measured by the Geriatric Depression Scale (GDS-15). The GDS-15 is a 15-item self-report scale tested and used extensively with older adults. Scores of 0-4 are considered normal, while scores of 5-8 signify mild depression, 9-11 signify moderate depression, and 12-15 indicate severe depression. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a negative mean indicates an improvement in depressive symptoms.
Outcome measures
| Measure |
Experimental
n=31 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Wait-List Control
n=30 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
|---|---|---|
|
Change in Depression as Assessed by the Geriatric Depression Scale
|
-1.3 score on a scale
Standard Deviation 2.1
|
-0.2 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Baseline and 4 monthsAnxiety in persons with dementia will be measured by the Geriatric Anxiety Inventory (GAI). The GAI is comprised of 20 "Agree/Disagree" items designed to assess typical common anxiety symptoms. Scores range from zero (low anxiety) to 63 (high anxiety). The following cutoff scores are supported in the literature: 0-7 (normal anxiety), 8-15 (mild-moderate anxiety), 16-25 (moderate-severe anxiety), and 26-63 (severe anxiety). The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a negative mean indicates an improvement in symptoms of anxiety.
Outcome measures
| Measure |
Experimental
n=31 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Wait-List Control
n=30 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
|---|---|---|
|
Change in Anxiety as Assessed by the Geriatric Anxiety Inventory
|
-2.4 score on a scale
Standard Deviation 4.8
|
-0.6 score on a scale
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: Baseline and 4 monthsSense of control in persons with dementia will be measured by the Sense of Control Scale. This scale has 12 items that measure a person's sense of control over her or his life. Items are scored on a seven-point Likert scale (1=strongly disagree' 2=disagree somewhat' 3=disagree a little' 4=don't know' 5=agree a little, 6=agree somewhat' and 7=strongly agree). Scores range from 12-84, with higher scores indicating greater perceived control. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean.
Outcome measures
| Measure |
Experimental
n=31 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Wait-List Control
n=30 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
|---|---|---|
|
Change in Sense of Control as Assessed by the MIDI Sense of Control Scale
|
3.6 score on a scale
Standard Deviation 6.5
|
0.7 score on a scale
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: Baseline and 4 monthsSense of control in persons with dementia will be measured by the Wallhagen Perceived Control Questionnaire (PCQ), a 20-item self-report instrument assessing two dimensions of perceived control: (a) Manageability, or belief in one's ability to handle demands, and (b) Goal Attainment, or belief that one can achieve self-set or externally imposed goals. Each item is rated on a 5-point Likert scale from 1 = Strongly Disagree to 5 = Strongly Agree (total score range: 20 to 100, with higher scores indicating greater perceived control). Both the manageability and goal attainment subscales consist of 10 items (score range: 10-50). Subscale scores are summed to compute the total score. The primary outcome is reported as a change score, calculated as T2 (4 months) - T1 (baseline). A positive change score indicates improved perceived control at the group level.
Outcome measures
| Measure |
Experimental
n=31 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Wait-List Control
n=30 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
|---|---|---|
|
Change in Sense of Control as Assessed by the Wallhagen Perceived Control Questionnaire
|
3.1 score on a scale
Standard Deviation 6.4
|
0.8 score on a scale
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Baseline and 4 monthsSense of self is assessed using the Identity-Alzheimer Moderate (I-AM) Test, where participants complete 20 "I am…" statements. Responses are given orally and recorded by the examiner. Responses are classified using the Watkins et al. (2006) scoring system into four identity categories: idiocentric, small-group, large-group, and allocentric. Stability is measured as the proportion of identity categories present at both T1 (baseline) and T2 (4 months), divided by the total number of unique categories used across both time points (range: 0 to 1). Higher values indicate greater identity stability.
Outcome measures
| Measure |
Experimental
n=31 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
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Wait-List Control
n=30 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
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|---|---|---|
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Change in Sense of Self as Assessed by the Identity-Alzheimer Moderate Test
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0.08 proportion of identical categories
Standard Deviation 0.18
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0.01 proportion of identical categories
Standard Deviation 0.20
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SECONDARY outcome
Timeframe: Baseline and 4 monthsSense of self in persons with dementia will be measured by the IMAGE test (denoted only by the acronym IMAGE). This test is comprised of 24 descriptive statements, 21 of which refer to the concepts of identity, behavior, and self-satisfaction. Each component contains seven statements belonging to one of seven self-concept domains (moral-ethical, social, personal, physical, family, cognition, emotion). Responses are scored on a four-point Likert scale as follows: 1=totally false, 2=partly false, 3=partly true, and 4=totally true. The total score was obtained by summing all items (minimum score = 24, maximum score = 96), with higher scores indicating more intact sense of self in a given domain. The outcome reported is the mean(SD) of the IMAGE score for each group. The outcome is measured as a change score, calculated as T2 (4 months) - T1 (baseline), whereby a positive mean indicates an improvement in the group mean.
Outcome measures
| Measure |
Experimental
n=31 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Wait-List Control
n=30 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
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|---|---|---|
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Change in Sense of Self as Assessed by the IMAGE Test
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3.5 score on a scale
Standard Deviation 6.5
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0.7 score on a scale
Standard Deviation 6.4
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline onlyGeneral intellectual abilities/premorbid cognitive functioning will be assessed via the Test of Premorbid Functioning (TOPF). The TOPF is composed of 70 irregularly spelled words and takes approximately 10 minutes to complete. The participant reads each word aloud. As correct pronunciation of irregular words relies on previously acquired knowledge, it tends to be resistant to brain damage and serves as a proxy for premorbid IQ. The test is discontinued when the participant provides five consecutive incorrect pronunciations. Each correct pronunciation is given a score of 1, and raw scores range from 0-70 with higher scores indicating higher premorbid cognitive function. The raw score is standardized by age and a scaled score is obtained by comparing to the participant's score to normative data based on their demographic classification.
Outcome measures
| Measure |
Experimental
n=31 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia. Persons randomized to the User-Led Meaningful Activity intervention group will begin the treatment protocol right after randomization. The intervention will consist of 3-4 sessions lasting 60-90 minutes each in which participants receive feedback from the neuropsychological assessment, identify the basis/topic of the activity plan, receive dementia psychoeducation, and map out an activity gradation plan. A brief cognitive screening tool will be re-administered at six months and 12 months. The neuropsychological battery that was administered at baseline will be re-administered 12 months later. Follow-up will also involve solicitation of feedback from the person with dementia and his or her caregiver regarding participants' participation in the study.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
Wait-List Control
n=30 Participants
After participants are recruited, participants will undergo neuropsychological testing prior to randomization in order to establish baseline cognitive functioning and verify that the participants are indeed in the early stages of dementia (i.e., "mild" dementia). Those who meet criteria will be randomly assigned. Persons randomized to the wait-list control group will begin the treatment protocol after four months' time.
User-Led Meaningful Activity Plan: The User-Led Meaningful Activity Plan integrates persons with dementia as partners in the co-construction of an intervention involving personally meaningful activity. Activities are graded to correspond with disease progression.
|
|---|---|---|
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Premorbid Cognitive Function as Assessed by the Test of Premorbid Functioning
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54.5 score on a scale
Standard Deviation 6.2
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53.1 score on a scale
Standard Deviation 5.9
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Adverse Events
Experimental
Wait-List Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place