Trial Outcomes & Findings for Improving Prospective Memory Via Telehealth (NCT NCT05129293)
NCT ID: NCT05129293
Last Updated: 2024-10-18
Results Overview
Performance on objective prospective memory (overall performance). The MIST Total Score is calculated by summing the raw scores from the six subscales, which is transformed into percentiles using age- and education-stratified normative data. Scores ranged from \<1 9 (coded as 0 for analyses) to \>99 (coded as 100 for analyses), with higher scores indicating better prospective memory performance.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
Six weeks
Results posted on
2024-10-18
Participant Flow
Participant milestones
| Measure |
Prospective Memory Intervention
Participants randomized to the PM intervention (active group) will meet with an interventionist twice a week for four weeks. The first four sessions will focus on visual imagery, while the last four sessions will focus on implementation intentions. Participants will be led through a manualized treatment.
Prospective Memory Intervention: Cognitive remediation focusing on prospective memory
|
Educational
The control group (Education) will meet with a research assistant for the same frequency of sessions and will receive psychoeducation on MS and cognitive functioning. The interventionists will be following a manual and accompanying PowerPoint slides.
Educational: Psychoeducation
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
|
Overall Study
COMPLETED
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Prospective Memory Via Telehealth
Baseline characteristics by cohort
| Measure |
Prospective Memory Intervention
n=17 Participants
Participants randomized to the PM intervention (active group) will meet with an interventionist twice a week for four weeks. The first four sessions will focus on visual imagery, while the last four sessions will focus on implementation intentions. Participants will be led through a manualized treatment.
Prospective Memory Intervention: Cognitive remediation focusing on prospective memory
|
Educational
n=18 Participants
The control group (Education) will meet with a research assistant for the same frequency of sessions and will receive psychoeducation on MS and cognitive functioning. The interventionists will be following a manual and accompanying PowerPoint slides.
Educational: Psychoeducation
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.29 years
STANDARD_DEVIATION 9.15 • n=5 Participants
|
48.17 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
47.74 years
STANDARD_DEVIATION 9.37 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Multi-racial/Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Six weeksPerformance on objective prospective memory (overall performance). The MIST Total Score is calculated by summing the raw scores from the six subscales, which is transformed into percentiles using age- and education-stratified normative data. Scores ranged from \<1 9 (coded as 0 for analyses) to \>99 (coded as 100 for analyses), with higher scores indicating better prospective memory performance.
Outcome measures
| Measure |
Prospective Memory Intervention
n=17 Participants
Participants randomized to the PM intervention (active group) will meet with an interventionist twice a week for four weeks. The first four sessions will focus on visual imagery, while the last four sessions will focus on implementation intentions. Participants will be led through a manualized treatment.
Prospective Memory Intervention: Cognitive remediation focusing on prospective memory
|
Educational
n=18 Participants
The control group (Education) will meet with a research assistant for the same frequency of sessions and will receive psychoeducation on MS and cognitive functioning. The interventionists will be following a manual and accompanying PowerPoint slides.
Educational: Psychoeducation
|
|---|---|---|
|
Memory for Intentions Test Total Score Percentile
Baseline
|
32.24 Percentile
Standard Deviation 21.78
|
38.94 Percentile
Standard Deviation 24.29
|
|
Memory for Intentions Test Total Score Percentile
Post-Treatment
|
35.02 Percentile
Standard Deviation 22.77
|
45.40 Percentile
Standard Deviation 36.62
|
PRIMARY outcome
Timeframe: Six weeksPerformance on objective prospective memory (time-based)
Outcome measures
| Measure |
Prospective Memory Intervention
n=17 Participants
Participants randomized to the PM intervention (active group) will meet with an interventionist twice a week for four weeks. The first four sessions will focus on visual imagery, while the last four sessions will focus on implementation intentions. Participants will be led through a manualized treatment.
Prospective Memory Intervention: Cognitive remediation focusing on prospective memory
|
Educational
n=18 Participants
The control group (Education) will meet with a research assistant for the same frequency of sessions and will receive psychoeducation on MS and cognitive functioning. The interventionists will be following a manual and accompanying PowerPoint slides.
Educational: Psychoeducation
|
|---|---|---|
|
Memory for Intentions Test Time Cue Subscale Percentile
Baseline
|
35.00 Percentile
Standard Deviation 19.75
|
51.78 Percentile
Standard Deviation 24.09
|
|
Memory for Intentions Test Time Cue Subscale Percentile
Post-treatment
|
57.89 Percentile
Standard Deviation 30.53
|
59.52 Percentile
Standard Deviation 29.89
|
SECONDARY outcome
Timeframe: Six weeksSubjective prospective memory. The five items in the subscale are summed, with scores ranging between 0 and 20. Higher scores indicate more subjective prospective memory issues.
Outcome measures
| Measure |
Prospective Memory Intervention
n=17 Participants
Participants randomized to the PM intervention (active group) will meet with an interventionist twice a week for four weeks. The first four sessions will focus on visual imagery, while the last four sessions will focus on implementation intentions. Participants will be led through a manualized treatment.
Prospective Memory Intervention: Cognitive remediation focusing on prospective memory
|
Educational
n=18 Participants
The control group (Education) will meet with a research assistant for the same frequency of sessions and will receive psychoeducation on MS and cognitive functioning. The interventionists will be following a manual and accompanying PowerPoint slides.
Educational: Psychoeducation
|
|---|---|---|
|
Perceived Deficits Questionnaire-Prospective Memory Subscale
Baseline
|
10.18 score on a scale
Standard Deviation 2.70
|
8.44 score on a scale
Standard Deviation 2.55
|
|
Perceived Deficits Questionnaire-Prospective Memory Subscale
Post-Treatment
|
8.79 score on a scale
Standard Deviation 2.60
|
8.30 score on a scale
Standard Deviation 2.74
|
Adverse Events
Prospective Memory Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Educational
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mandell Center Research Team
Trinity Health Of New England
Phone: 860-714-3005
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place