Trial Outcomes & Findings for Piloting the IPROACTIF Program to Preserve Functioning and Prevent Cognitive Decline (NCT NCT04682977)
NCT ID: NCT04682977
Last Updated: 2025-08-19
Results Overview
Validated self-reported assessment; respondent identifies up to 5 important activities they are experiencing difficulty with. Total score = sum of the activity scores/number of activities. scoring Scores can range from 0 to 10; higher scores indicate better physical functioning Minimal clinically important difference in previous studies = 1.2-2.2 points
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-08-19
Participant Flow
45 participants were enrolled. 5 participants who enrolled dropped out/were lost to follow up before randomization to groups. Specifically, these participants began but did not complete all baseline assessments. 40 of the enrolled participants completed all baseline assessments and were assigned to the study arms as indicated in the participant flow.
Participant milestones
| Measure |
IPROACTIF
10 weekly sessions. First two sessions focus on comprehensive assessment of physical and executive functioning, assessment of home safety and accessibility, assessment of ADL/IADL competence and performance in context; information in these areas is used by the interventionist to collaboratively identify three patient-centered goals. Goal planning is followed by 10 treatment sessions. Treatment sessions focus on chronic disease education, problem solving issues related to disease management by modifying daily routines, recommendations for embedding physical activity in everyday tasks, and environmental modifications or activity adaptations to increase ADL/IADL independence.
IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning): IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) is an intervention designed to be delivered in primary care settings by an on-site occupational therapist. Based on the premise of preventing the physical and cognitive decline that is associated with aging and chronic disease, the 12-week intervention includes a comprehensive assessment of ADL functioning and ten intervention sessions addressing disease management, physical activity and executive functioning.
|
Usual Care
Participants in the control group will receive usual services which might include primary care and prescription medications for chronic disease management.
Usual primary care services: Usual primary care services might include monitoring of vitals and other relevant laboratory testing, prescription of medications for chronic disease management, as well as counseling for lifestyle changes.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
22
|
|
Overall Study
COMPLETED
|
15
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Number analyzed is lower than the overall number for each group due to missing data. Not all participants returned the accelerometer with valid and usable data.
Baseline characteristics by cohort
| Measure |
IPROACTIF
n=18 Participants
10 weekly sessions. First two sessions focus on comprehensive assessment of physical and executive functioning, assessment of home safety and accessibility, assessment of ADL/IADL competence and performance in context; information in these areas is used by the interventionist to collaboratively identify three patient-centered goals. Goal planning is followed by 10 treatment sessions. Treatment sessions focus on chronic disease education, problem solving issues related to disease management by modifying daily routines, recommendations for embedding physical activity in everyday tasks, and environmental modifications or activity adaptations to increase ADL/IADL independence.
IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning): IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) is an intervention designed to be delivered in primary care settings by an on-site occupational therapist. Based on the premise of preventing the physical and cognitive decline that is associated with aging and chronic disease, the 12-week intervention includes a comprehensive assessment of ADL functioning and ten intervention sessions addressing disease management, physical activity and executive functioning.
|
Usual Care
n=22 Participants
Participants in the control group will receive usual services which might include primary care and prescription medications for chronic disease management.
Usual primary care services: Usual primary care services might include monitoring of vitals and other relevant laboratory testing, prescription of medications for chronic disease management, as well as counseling for lifestyle changes.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 7.0 • n=18 Participants
|
66.7 years
STANDARD_DEVIATION 7.2 • n=22 Participants
|
66.7 years
STANDARD_DEVIATION 7.2 • n=40 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=18 Participants
|
12 Participants
n=22 Participants
|
27 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=18 Participants
|
10 Participants
n=22 Participants
|
13 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=18 Participants
|
2 Participants
n=22 Participants
|
7 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=18 Participants
|
20 Participants
n=22 Participants
|
33 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=18 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=18 Participants
|
14 Participants
n=22 Participants
|
25 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=18 Participants
|
7 Participants
n=22 Participants
|
11 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=18 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=18 Participants
|
1 Participants
n=22 Participants
|
3 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=18 Participants
|
22 participants
n=22 Participants
|
40 participants
n=40 Participants
|
|
Patient-Specific Functional Scale
|
5.81 units on a scale
STANDARD_DEVIATION 2.08 • n=18 Participants
|
4.92 units on a scale
STANDARD_DEVIATION 1.63 • n=22 Participants
|
5.32 units on a scale
STANDARD_DEVIATION 1.88 • n=40 Participants
|
|
PROMIS Physical Function Short Form 20
|
41.12 T-score
STANDARD_DEVIATION 7.64 • n=18 Participants
|
40.12 T-score
STANDARD_DEVIATION 8.65 • n=22 Participants
|
40.57 T-score
STANDARD_DEVIATION 1.88 • n=40 Participants
|
|
Physical Performance Test
|
24.50 units on a scale
STANDARD_DEVIATION 6.38 • n=18 Participants
|
24.18 units on a scale
STANDARD_DEVIATION 7.30 • n=22 Participants
|
24.33 units on a scale
STANDARD_DEVIATION 6.82 • n=40 Participants
|
|
Exercise Regularly Scale from the Self-Management Resource Center
|
7.15 units on a scale
n=18 Participants
|
6.70 units on a scale
n=22 Participants
|
6.70 units on a scale
n=40 Participants
|
|
Obtain Help from Community, Family, Friends Scale from the Self-Management Resource Center
|
7.8 units on a scale
n=18 Participants
|
7 units on a scale
n=22 Participants
|
7.4 units on a scale
n=40 Participants
|
|
Manage Disease in General Scale from the Self-Management Resource Center
|
8.2 units on a scale
n=18 Participants
|
7.8 units on a scale
n=22 Participants
|
8 units on a scale
n=40 Participants
|
|
Social Recreational Activities Scale from the Self-Management Resource Center
|
7.75 units on a scale
n=18 Participants
|
7.5 units on a scale
n=22 Participants
|
7.5 units on a scale
n=40 Participants
|
|
Doing Chores Scale from the Self-Management Resource Center
|
8.15 units on a scale
n=18 Participants
|
7 units on a scale
n=22 Participants
|
7.85 units on a scale
n=40 Participants
|
|
Manage Symptoms Scale from the Self-Management Resource Center
|
7.1 units on a scale
n=18 Participants
|
6.2 units on a scale
n=22 Participants
|
6.7 units on a scale
n=40 Participants
|
|
Late Life Functioning and Disability Index (Disability Component) - Frequency Dimension
|
48.94 units on a scale
STANDARD_DEVIATION 5.64 • n=18 Participants
|
49.48 units on a scale
STANDARD_DEVIATION 8.55 • n=22 Participants
|
49.24 units on a scale
STANDARD_DEVIATION 7.30 • n=40 Participants
|
|
Late Life Functioning and Disability Index (Disability Component)- Limitations Dimension
|
66.26 units on a scale
STANDARD_DEVIATION 10.04 • n=18 Participants
|
66.62 units on a scale
STANDARD_DEVIATION 16.98 • n=22 Participants
|
66.46 units on a scale
STANDARD_DEVIATION 14.12 • n=40 Participants
|
|
PROMIS Global Health Measure (physical subscale)
|
42.36 T-score
STANDARD_DEVIATION 8.37 • n=18 Participants
|
42.14 T-score
STANDARD_DEVIATION 8.91 • n=22 Participants
|
42.24 T-score
STANDARD_DEVIATION 8.56 • n=40 Participants
|
|
PROMIS Global Health Measure (mental subscale)
|
44.88 T-score
STANDARD_DEVIATION 7.40 • n=18 Participants
|
45.53 T-score
STANDARD_DEVIATION 8.75 • n=22 Participants
|
45.24 T-score
STANDARD_DEVIATION 8.08 • n=40 Participants
|
|
Executive Function Performance Test
|
4.5 units on a scale
n=18 Participants
|
4 units on a scale
n=22 Participants
|
4 units on a scale
n=40 Participants
|
|
Performance Assessment of Self-care Skills
|
2.92 units on a scale
n=18 Participants
|
3 units on a scale
n=22 Participants
|
3 units on a scale
n=40 Participants
|
|
Average time spent in moderate to vigorous physical activity (accelerometry)
|
4.21 minutes
n=17 Participants • Number analyzed is lower than the overall number for each group due to missing data. Not all participants returned the accelerometer with valid and usable data.
|
5.04 minutes
n=19 Participants • Number analyzed is lower than the overall number for each group due to missing data. Not all participants returned the accelerometer with valid and usable data.
|
4.35 minutes
n=36 Participants • Number analyzed is lower than the overall number for each group due to missing data. Not all participants returned the accelerometer with valid and usable data.
|
|
Dimensional Change Card Sort
|
95 units on a scale
n=18 Participants
|
95 units on a scale
n=22 Participants
|
95 units on a scale
n=40 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
Validated self-reported assessment; respondent identifies up to 5 important activities they are experiencing difficulty with. Total score = sum of the activity scores/number of activities. scoring Scores can range from 0 to 10; higher scores indicate better physical functioning Minimal clinically important difference in previous studies = 1.2-2.2 points
Outcome measures
| Measure |
IPROACTIF
n=18 Participants
10 weekly sessions. First two sessions focus on comprehensive assessment of physical and executive functioning, assessment of home safety and accessibility, assessment of ADL/IADL competence and performance in context; information in these areas is used by the interventionist to collaboratively identify three patient-centered goals. Goal planning is followed by 10 treatment sessions. Treatment sessions focus on chronic disease education, problem solving issues related to disease management by modifying daily routines, recommendations for embedding physical activity in everyday tasks, and environmental modifications or activity adaptations to increase ADL/IADL independence.
IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning): IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) is an intervention designed to be delivered in primary care settings by an on-site occupational therapist. Based on the premise of preventing the physical and cognitive decline that is associated with aging and chronic disease, the 12-week intervention includes a comprehensive assessment of ADL functioning and ten intervention sessions addressing disease management, physical activity and executive functioning.
|
Usual Care
n=22 Participants
Participants in the control group will receive usual services which might include primary care and prescription medications for chronic disease management.
Usual primary care services: Usual primary care services might include monitoring of vitals and other relevant laboratory testing, prescription of medications for chronic disease management, as well as counseling for lifestyle changes.
|
|---|---|---|
|
Physical Functioning Measured Using the Patient-Specific Functional Scale
|
7.45 score on a scale
Standard Deviation 2.64
|
5.43 score on a scale
Standard Deviation 2.31
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
The PROMIS Physical Function Short Form 20 (PF-20) is a measure of perceived ability to perform physical activities. Respondents rate 20 daily activities on a scale from 1 (unable to do) to 5 (no difficulty/limitation). Individual item scores are summed to compute the total raw score which is converted to a standardized T-score. T-scores range from 9.2 to 62.7. Higher T-scores indicate a better outcome. A score of 50 is the average for the United States general population with a standard deviation of 10.
Outcome measures
| Measure |
IPROACTIF
n=18 Participants
10 weekly sessions. First two sessions focus on comprehensive assessment of physical and executive functioning, assessment of home safety and accessibility, assessment of ADL/IADL competence and performance in context; information in these areas is used by the interventionist to collaboratively identify three patient-centered goals. Goal planning is followed by 10 treatment sessions. Treatment sessions focus on chronic disease education, problem solving issues related to disease management by modifying daily routines, recommendations for embedding physical activity in everyday tasks, and environmental modifications or activity adaptations to increase ADL/IADL independence.
IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning): IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) is an intervention designed to be delivered in primary care settings by an on-site occupational therapist. Based on the premise of preventing the physical and cognitive decline that is associated with aging and chronic disease, the 12-week intervention includes a comprehensive assessment of ADL functioning and ten intervention sessions addressing disease management, physical activity and executive functioning.
|
Usual Care
n=22 Participants
Participants in the control group will receive usual services which might include primary care and prescription medications for chronic disease management.
Usual primary care services: Usual primary care services might include monitoring of vitals and other relevant laboratory testing, prescription of medications for chronic disease management, as well as counseling for lifestyle changes.
|
|---|---|---|
|
Physical Functioning Measured Using the PROMIS Physical Function Short Form 20
|
43.91 units on a scale
Standard Deviation 12.06
|
40.79 units on a scale
Standard Deviation 9.69
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
9-item performance-based assessment; scores can range from 0 to 36; higher scores indicate better physical functioning Minimal clinically important difference in previous studies = 2.4 points
Outcome measures
| Measure |
IPROACTIF
n=18 Participants
10 weekly sessions. First two sessions focus on comprehensive assessment of physical and executive functioning, assessment of home safety and accessibility, assessment of ADL/IADL competence and performance in context; information in these areas is used by the interventionist to collaboratively identify three patient-centered goals. Goal planning is followed by 10 treatment sessions. Treatment sessions focus on chronic disease education, problem solving issues related to disease management by modifying daily routines, recommendations for embedding physical activity in everyday tasks, and environmental modifications or activity adaptations to increase ADL/IADL independence.
IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning): IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) is an intervention designed to be delivered in primary care settings by an on-site occupational therapist. Based on the premise of preventing the physical and cognitive decline that is associated with aging and chronic disease, the 12-week intervention includes a comprehensive assessment of ADL functioning and ten intervention sessions addressing disease management, physical activity and executive functioning.
|
Usual Care
n=22 Participants
Participants in the control group will receive usual services which might include primary care and prescription medications for chronic disease management.
Usual primary care services: Usual primary care services might include monitoring of vitals and other relevant laboratory testing, prescription of medications for chronic disease management, as well as counseling for lifestyle changes.
|
|---|---|---|
|
Physical Functioning Measured Using the Physical Performance Test (9-item)
|
24.7 score on a scale
Standard Deviation 8.73
|
25.4 score on a scale
Standard Deviation 6.42
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
16-item self-reported measure; scaled scores for the frequency dimension range from 0-100; higher scores indicate greater frequency i.e. better performance.
Outcome measures
| Measure |
IPROACTIF
n=18 Participants
10 weekly sessions. First two sessions focus on comprehensive assessment of physical and executive functioning, assessment of home safety and accessibility, assessment of ADL/IADL competence and performance in context; information in these areas is used by the interventionist to collaboratively identify three patient-centered goals. Goal planning is followed by 10 treatment sessions. Treatment sessions focus on chronic disease education, problem solving issues related to disease management by modifying daily routines, recommendations for embedding physical activity in everyday tasks, and environmental modifications or activity adaptations to increase ADL/IADL independence.
IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning): IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) is an intervention designed to be delivered in primary care settings by an on-site occupational therapist. Based on the premise of preventing the physical and cognitive decline that is associated with aging and chronic disease, the 12-week intervention includes a comprehensive assessment of ADL functioning and ten intervention sessions addressing disease management, physical activity and executive functioning.
|
Usual Care
n=22 Participants
Participants in the control group will receive usual services which might include primary care and prescription medications for chronic disease management.
Usual primary care services: Usual primary care services might include monitoring of vitals and other relevant laboratory testing, prescription of medications for chronic disease management, as well as counseling for lifestyle changes.
|
|---|---|---|
|
Participation in Life Activities and Roles Using the Late Life Functioning and Disability Index (Disability Component) - Frequency Dimension
|
52.01 score on a scale
Standard Deviation 7.02
|
50.30 score on a scale
Standard Deviation 9.39
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
16-item self-reported measure; scaled scores for the frequency dimension range from 0-100; higher scores indicate lesser difficulty i.e. better performance.
Outcome measures
| Measure |
IPROACTIF
n=18 Participants
10 weekly sessions. First two sessions focus on comprehensive assessment of physical and executive functioning, assessment of home safety and accessibility, assessment of ADL/IADL competence and performance in context; information in these areas is used by the interventionist to collaboratively identify three patient-centered goals. Goal planning is followed by 10 treatment sessions. Treatment sessions focus on chronic disease education, problem solving issues related to disease management by modifying daily routines, recommendations for embedding physical activity in everyday tasks, and environmental modifications or activity adaptations to increase ADL/IADL independence.
IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning): IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) is an intervention designed to be delivered in primary care settings by an on-site occupational therapist. Based on the premise of preventing the physical and cognitive decline that is associated with aging and chronic disease, the 12-week intervention includes a comprehensive assessment of ADL functioning and ten intervention sessions addressing disease management, physical activity and executive functioning.
|
Usual Care
n=22 Participants
Participants in the control group will receive usual services which might include primary care and prescription medications for chronic disease management.
Usual primary care services: Usual primary care services might include monitoring of vitals and other relevant laboratory testing, prescription of medications for chronic disease management, as well as counseling for lifestyle changes.
|
|---|---|---|
|
Participation in Life Activities and Roles Using the Late Life Functioning and Disability Index (Disability Component) - Limitations Dimension
|
74.70 score on a scale
Standard Deviation 26.17
|
70.41 score on a scale
Standard Deviation 21.03
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
The PROMIS Global Health Short Form is a 10-item self-report assessment of health-related quality of life (HRQOL). Item scores are summed to compute raw scores for physical and mental health. Raw scores are converted to T-scores using a standard conversion table. T-scores for the physical health sub-scale range from 16.2 to 67.7. A T-Score of 50 represents the average (mean) for the US general population with a standard deviation of 10 points. Higher T-scores indicate a better outcome.
Outcome measures
| Measure |
IPROACTIF
n=18 Participants
10 weekly sessions. First two sessions focus on comprehensive assessment of physical and executive functioning, assessment of home safety and accessibility, assessment of ADL/IADL competence and performance in context; information in these areas is used by the interventionist to collaboratively identify three patient-centered goals. Goal planning is followed by 10 treatment sessions. Treatment sessions focus on chronic disease education, problem solving issues related to disease management by modifying daily routines, recommendations for embedding physical activity in everyday tasks, and environmental modifications or activity adaptations to increase ADL/IADL independence.
IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning): IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) is an intervention designed to be delivered in primary care settings by an on-site occupational therapist. Based on the premise of preventing the physical and cognitive decline that is associated with aging and chronic disease, the 12-week intervention includes a comprehensive assessment of ADL functioning and ten intervention sessions addressing disease management, physical activity and executive functioning.
|
Usual Care
n=22 Participants
Participants in the control group will receive usual services which might include primary care and prescription medications for chronic disease management.
Usual primary care services: Usual primary care services might include monitoring of vitals and other relevant laboratory testing, prescription of medications for chronic disease management, as well as counseling for lifestyle changes.
|
|---|---|---|
|
Health Related Quality of Life Using the PROMIS Global Health Measure (Physical Subscale)
|
48.36 score on a scale
Standard Deviation 15.90
|
43.21 score on a scale
Standard Deviation 8.89
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
The PROMIS Global Health Short Form is a 10-item self-report assessment of health-related quality of life (HRQOL). Item scores are summed to compute raw scores for physical and mental health. Raw scores are converted to T-scores using a standard conversion table. T-scores for the mental health sub-scale range from 21.2 to 67.6. A T-Score of 50 represents the average (mean) for the US general population with a standard deviation of 10 points. Higher T-scores indicate a better outcome.
Outcome measures
| Measure |
IPROACTIF
n=18 Participants
10 weekly sessions. First two sessions focus on comprehensive assessment of physical and executive functioning, assessment of home safety and accessibility, assessment of ADL/IADL competence and performance in context; information in these areas is used by the interventionist to collaboratively identify three patient-centered goals. Goal planning is followed by 10 treatment sessions. Treatment sessions focus on chronic disease education, problem solving issues related to disease management by modifying daily routines, recommendations for embedding physical activity in everyday tasks, and environmental modifications or activity adaptations to increase ADL/IADL independence.
IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning): IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) is an intervention designed to be delivered in primary care settings by an on-site occupational therapist. Based on the premise of preventing the physical and cognitive decline that is associated with aging and chronic disease, the 12-week intervention includes a comprehensive assessment of ADL functioning and ten intervention sessions addressing disease management, physical activity and executive functioning.
|
Usual Care
n=22 Participants
Participants in the control group will receive usual services which might include primary care and prescription medications for chronic disease management.
Usual primary care services: Usual primary care services might include monitoring of vitals and other relevant laboratory testing, prescription of medications for chronic disease management, as well as counseling for lifestyle changes.
|
|---|---|---|
|
Health Related Quality of Life Using the PROMIS Global Health Measure (Mental Subscale)
|
45.71 score on a scale
Standard Deviation 8.23
|
46.38 score on a scale
Standard Deviation 7.93
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
This is a scale within the Chronic Disease Self-Efficacy Scales (CDSES) measure which assesses perceived confidence for performing specific behaviors for managing chronic health conditions and their sequelae. This scale includes 3 items. Items are rated on a scale of 1 (not at all confident) to 10 (totally confident). The total scale score is the mean of the items and can range from 1 to 10. Higher score indicates a better outcome.
Outcome measures
| Measure |
IPROACTIF
n=18 Participants
10 weekly sessions. First two sessions focus on comprehensive assessment of physical and executive functioning, assessment of home safety and accessibility, assessment of ADL/IADL competence and performance in context; information in these areas is used by the interventionist to collaboratively identify three patient-centered goals. Goal planning is followed by 10 treatment sessions. Treatment sessions focus on chronic disease education, problem solving issues related to disease management by modifying daily routines, recommendations for embedding physical activity in everyday tasks, and environmental modifications or activity adaptations to increase ADL/IADL independence.
IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning): IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) is an intervention designed to be delivered in primary care settings by an on-site occupational therapist. Based on the premise of preventing the physical and cognitive decline that is associated with aging and chronic disease, the 12-week intervention includes a comprehensive assessment of ADL functioning and ten intervention sessions addressing disease management, physical activity and executive functioning.
|
Usual Care
n=22 Participants
Participants in the control group will receive usual services which might include primary care and prescription medications for chronic disease management.
Usual primary care services: Usual primary care services might include monitoring of vitals and other relevant laboratory testing, prescription of medications for chronic disease management, as well as counseling for lifestyle changes.
|
|---|---|---|
|
Self-efficacy Measured Using the Doing Chores Scale From the Self-Management Resource Center
|
8.14 score on a scale
Standard Deviation 2.36
|
6.98 score on a scale
Standard Deviation 3.04
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
This is a scale within the Chronic Disease Self-Efficacy Scales (CDSES) measure which assesses perceived confidence for performing specific behaviors for managing chronic health conditions and their sequelae. This scale includes 5 items. Items are rated on a scale of 1 (not at all confident) to 10 (totally confident). The total scale score is the mean of the items and can range from 1 to 10. Higher score indicates a better outcome.
Outcome measures
| Measure |
IPROACTIF
n=18 Participants
10 weekly sessions. First two sessions focus on comprehensive assessment of physical and executive functioning, assessment of home safety and accessibility, assessment of ADL/IADL competence and performance in context; information in these areas is used by the interventionist to collaboratively identify three patient-centered goals. Goal planning is followed by 10 treatment sessions. Treatment sessions focus on chronic disease education, problem solving issues related to disease management by modifying daily routines, recommendations for embedding physical activity in everyday tasks, and environmental modifications or activity adaptations to increase ADL/IADL independence.
IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning): IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) is an intervention designed to be delivered in primary care settings by an on-site occupational therapist. Based on the premise of preventing the physical and cognitive decline that is associated with aging and chronic disease, the 12-week intervention includes a comprehensive assessment of ADL functioning and ten intervention sessions addressing disease management, physical activity and executive functioning.
|
Usual Care
n=22 Participants
Participants in the control group will receive usual services which might include primary care and prescription medications for chronic disease management.
Usual primary care services: Usual primary care services might include monitoring of vitals and other relevant laboratory testing, prescription of medications for chronic disease management, as well as counseling for lifestyle changes.
|
|---|---|---|
|
Self-efficacy Measured Using the Manage Symptoms Scale From the Self-Management Resource Center
|
7.30 score on a scale
Standard Deviation 2.05
|
7.18 score on a scale
Standard Deviation 2.21
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
Change from pre-test (baseline) to post-test (12 weeks) in self-efficacy for getting support from others as measured on a 4-item validated self-reported assessment; Scores range from 1 to 10; higher scores indicate better self-efficacy
Outcome measures
| Measure |
IPROACTIF
n=18 Participants
10 weekly sessions. First two sessions focus on comprehensive assessment of physical and executive functioning, assessment of home safety and accessibility, assessment of ADL/IADL competence and performance in context; information in these areas is used by the interventionist to collaboratively identify three patient-centered goals. Goal planning is followed by 10 treatment sessions. Treatment sessions focus on chronic disease education, problem solving issues related to disease management by modifying daily routines, recommendations for embedding physical activity in everyday tasks, and environmental modifications or activity adaptations to increase ADL/IADL independence.
IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning): IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) is an intervention designed to be delivered in primary care settings by an on-site occupational therapist. Based on the premise of preventing the physical and cognitive decline that is associated with aging and chronic disease, the 12-week intervention includes a comprehensive assessment of ADL functioning and ten intervention sessions addressing disease management, physical activity and executive functioning.
|
Usual Care
n=22 Participants
Participants in the control group will receive usual services which might include primary care and prescription medications for chronic disease management.
Usual primary care services: Usual primary care services might include monitoring of vitals and other relevant laboratory testing, prescription of medications for chronic disease management, as well as counseling for lifestyle changes.
|
|---|---|---|
|
Self-efficacy for Chronic Disease Management Using the Obtain Help From Community, Family, Friends Scale From the Self-Management Resource Center
|
0.10 score on a scale
Interval -3.3 to 5.3
|
0.35 score on a scale
Interval -2.8 to 4.2
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
Change from pre-test (baseline) to post-test (12 weeks) in self-efficacy for general disease management as measured on a 5-item validated self-reported assessment; Scores range from 1 to 10; higher scores indicate better self-efficacy
Outcome measures
| Measure |
IPROACTIF
n=18 Participants
10 weekly sessions. First two sessions focus on comprehensive assessment of physical and executive functioning, assessment of home safety and accessibility, assessment of ADL/IADL competence and performance in context; information in these areas is used by the interventionist to collaboratively identify three patient-centered goals. Goal planning is followed by 10 treatment sessions. Treatment sessions focus on chronic disease education, problem solving issues related to disease management by modifying daily routines, recommendations for embedding physical activity in everyday tasks, and environmental modifications or activity adaptations to increase ADL/IADL independence.
IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning): IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) is an intervention designed to be delivered in primary care settings by an on-site occupational therapist. Based on the premise of preventing the physical and cognitive decline that is associated with aging and chronic disease, the 12-week intervention includes a comprehensive assessment of ADL functioning and ten intervention sessions addressing disease management, physical activity and executive functioning.
|
Usual Care
n=22 Participants
Participants in the control group will receive usual services which might include primary care and prescription medications for chronic disease management.
Usual primary care services: Usual primary care services might include monitoring of vitals and other relevant laboratory testing, prescription of medications for chronic disease management, as well as counseling for lifestyle changes.
|
|---|---|---|
|
Self-efficacy for Chronic Disease Management Using the Manage Disease in General Scale From the Self-Management Resource Center
|
0.20 score on a scale
Interval -3.88 to 3.2
|
0.00 score on a scale
Interval -4.2 to 3.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
Change from pre-test (baseline) to post-test (12 weeks) in self-efficacy for engaging in social and recreational activities as measured on a 2-item validated self-reported assessment; Scores range from 1 to 10; higher scores indicate better self-efficacy
Outcome measures
| Measure |
IPROACTIF
n=18 Participants
10 weekly sessions. First two sessions focus on comprehensive assessment of physical and executive functioning, assessment of home safety and accessibility, assessment of ADL/IADL competence and performance in context; information in these areas is used by the interventionist to collaboratively identify three patient-centered goals. Goal planning is followed by 10 treatment sessions. Treatment sessions focus on chronic disease education, problem solving issues related to disease management by modifying daily routines, recommendations for embedding physical activity in everyday tasks, and environmental modifications or activity adaptations to increase ADL/IADL independence.
IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning): IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) is an intervention designed to be delivered in primary care settings by an on-site occupational therapist. Based on the premise of preventing the physical and cognitive decline that is associated with aging and chronic disease, the 12-week intervention includes a comprehensive assessment of ADL functioning and ten intervention sessions addressing disease management, physical activity and executive functioning.
|
Usual Care
n=22 Participants
Participants in the control group will receive usual services which might include primary care and prescription medications for chronic disease management.
Usual primary care services: Usual primary care services might include monitoring of vitals and other relevant laboratory testing, prescription of medications for chronic disease management, as well as counseling for lifestyle changes.
|
|---|---|---|
|
Self-efficacy for Chronic Disease Management Using the Social Recreational Activities Scale From the Self-Management Resource Center
|
0.02 score on a scale
Interval -2.5 to 5.0
|
0.50 score on a scale
Interval -5.0 to 3.04
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
Change from pre-test (baseline) to post-test (12 weeks) in self-efficacy for getting regular exercise as measured on a 3-item validated self-reported assessment; scores range from 1 to 10; higher scores indicate better self-efficacy
Outcome measures
| Measure |
IPROACTIF
n=18 Participants
10 weekly sessions. First two sessions focus on comprehensive assessment of physical and executive functioning, assessment of home safety and accessibility, assessment of ADL/IADL competence and performance in context; information in these areas is used by the interventionist to collaboratively identify three patient-centered goals. Goal planning is followed by 10 treatment sessions. Treatment sessions focus on chronic disease education, problem solving issues related to disease management by modifying daily routines, recommendations for embedding physical activity in everyday tasks, and environmental modifications or activity adaptations to increase ADL/IADL independence.
IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning): IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) is an intervention designed to be delivered in primary care settings by an on-site occupational therapist. Based on the premise of preventing the physical and cognitive decline that is associated with aging and chronic disease, the 12-week intervention includes a comprehensive assessment of ADL functioning and ten intervention sessions addressing disease management, physical activity and executive functioning.
|
Usual Care
n=22 Participants
Participants in the control group will receive usual services which might include primary care and prescription medications for chronic disease management.
Usual primary care services: Usual primary care services might include monitoring of vitals and other relevant laboratory testing, prescription of medications for chronic disease management, as well as counseling for lifestyle changes.
|
|---|---|---|
|
Self-efficacy for Chronic Disease Management Using the Exercise Regularly Scale From the Self-Management Resource Center
|
1.02 score on a scale
Interval -2.4 to 6.3
|
0.24 score on a scale
Interval -3.7 to 5.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
Change from pre-test (baseline) to post-test (12 weeks) as measured on the Performance Assessment of Self-care Skills (PASS). The PASS is a performance-based assessment; individual is expected to perform an ADL/IADL task which is rated on independence, safety, and adequacy. Independence scores range from 0-3; higher scores indicate better performance
Outcome measures
| Measure |
IPROACTIF
n=18 Participants
10 weekly sessions. First two sessions focus on comprehensive assessment of physical and executive functioning, assessment of home safety and accessibility, assessment of ADL/IADL competence and performance in context; information in these areas is used by the interventionist to collaboratively identify three patient-centered goals. Goal planning is followed by 10 treatment sessions. Treatment sessions focus on chronic disease education, problem solving issues related to disease management by modifying daily routines, recommendations for embedding physical activity in everyday tasks, and environmental modifications or activity adaptations to increase ADL/IADL independence.
IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning): IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) is an intervention designed to be delivered in primary care settings by an on-site occupational therapist. Based on the premise of preventing the physical and cognitive decline that is associated with aging and chronic disease, the 12-week intervention includes a comprehensive assessment of ADL functioning and ten intervention sessions addressing disease management, physical activity and executive functioning.
|
Usual Care
n=22 Participants
Participants in the control group will receive usual services which might include primary care and prescription medications for chronic disease management.
Usual primary care services: Usual primary care services might include monitoring of vitals and other relevant laboratory testing, prescription of medications for chronic disease management, as well as counseling for lifestyle changes.
|
|---|---|---|
|
Performance of Daily Living Tasks Using the Performance Assessment of Self-care Skills
|
0.09 score on a scale
Interval -1.6 to 1.5
|
0.00 score on a scale
Interval -0.69 to 2.17
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
Change from pre-test (baseline) to post-test (12 weeks) as measured on the Executive Function Performance Test (EFPT). The EFPT is a performance-based assessment; original assessment comprises three tasks; only the medication management task was used; scores range from 0-25 for this task; higher scores indicate poorer performance.
Outcome measures
| Measure |
IPROACTIF
n=18 Participants
10 weekly sessions. First two sessions focus on comprehensive assessment of physical and executive functioning, assessment of home safety and accessibility, assessment of ADL/IADL competence and performance in context; information in these areas is used by the interventionist to collaboratively identify three patient-centered goals. Goal planning is followed by 10 treatment sessions. Treatment sessions focus on chronic disease education, problem solving issues related to disease management by modifying daily routines, recommendations for embedding physical activity in everyday tasks, and environmental modifications or activity adaptations to increase ADL/IADL independence.
IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning): IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) is an intervention designed to be delivered in primary care settings by an on-site occupational therapist. Based on the premise of preventing the physical and cognitive decline that is associated with aging and chronic disease, the 12-week intervention includes a comprehensive assessment of ADL functioning and ten intervention sessions addressing disease management, physical activity and executive functioning.
|
Usual Care
n=22 Participants
Participants in the control group will receive usual services which might include primary care and prescription medications for chronic disease management.
Usual primary care services: Usual primary care services might include monitoring of vitals and other relevant laboratory testing, prescription of medications for chronic disease management, as well as counseling for lifestyle changes.
|
|---|---|---|
|
Executive Functioning Using the Executive Function Performance Test
|
1.70 score on a scale
Interval -9.0 to 7.0
|
1.00 score on a scale
Interval -6.0 to 7.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intent to Treat population (all participants assigned to IPROACTIF or Control). Expectation Maximization imputation method.
The NIH Toolbox Dimensional Change Card Sort (DCCS) Test is a computer-administered measure of cognitive flexibility and attention. Test takers match bivalent test pictures to the target pictures along dimensions of shape and color. Scoring is based on combining accuracy and reaction time \& converted to a scale score with mean of 100 and SD of 15. Scale scores may be adjusted for age. Adjusted scores are relative to a normative sample with no universally applicable fixed minimum or maximum. Higher scores indicate better performance. Scores listed represent unadjusted scale scores.
Outcome measures
| Measure |
IPROACTIF
n=18 Participants
10 weekly sessions. First two sessions focus on comprehensive assessment of physical and executive functioning, assessment of home safety and accessibility, assessment of ADL/IADL competence and performance in context; information in these areas is used by the interventionist to collaboratively identify three patient-centered goals. Goal planning is followed by 10 treatment sessions. Treatment sessions focus on chronic disease education, problem solving issues related to disease management by modifying daily routines, recommendations for embedding physical activity in everyday tasks, and environmental modifications or activity adaptations to increase ADL/IADL independence.
IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning): IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) is an intervention designed to be delivered in primary care settings by an on-site occupational therapist. Based on the premise of preventing the physical and cognitive decline that is associated with aging and chronic disease, the 12-week intervention includes a comprehensive assessment of ADL functioning and ten intervention sessions addressing disease management, physical activity and executive functioning.
|
Usual Care
n=22 Participants
Participants in the control group will receive usual services which might include primary care and prescription medications for chronic disease management.
Usual primary care services: Usual primary care services might include monitoring of vitals and other relevant laboratory testing, prescription of medications for chronic disease management, as well as counseling for lifestyle changes.
|
|---|---|---|
|
Executive Functioning Using the Dimensional Change Card Sort Test
|
4.00 score on a scale
Interval -36.0 to 18.87
|
3.94 score on a scale
Interval -7.0 to 32.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intent to Treat population (all participants assigned to IPROACTIF or Control).
Change from pre-test (baseline) to post-test (12 weeks) in the average time spent in moderate to vigorous physical activity as measured by an accelerometer worn for at least 6 hours for at least 4 days during a 7-day period.
Outcome measures
| Measure |
IPROACTIF
n=13 Participants
10 weekly sessions. First two sessions focus on comprehensive assessment of physical and executive functioning, assessment of home safety and accessibility, assessment of ADL/IADL competence and performance in context; information in these areas is used by the interventionist to collaboratively identify three patient-centered goals. Goal planning is followed by 10 treatment sessions. Treatment sessions focus on chronic disease education, problem solving issues related to disease management by modifying daily routines, recommendations for embedding physical activity in everyday tasks, and environmental modifications or activity adaptations to increase ADL/IADL independence.
IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning): IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) is an intervention designed to be delivered in primary care settings by an on-site occupational therapist. Based on the premise of preventing the physical and cognitive decline that is associated with aging and chronic disease, the 12-week intervention includes a comprehensive assessment of ADL functioning and ten intervention sessions addressing disease management, physical activity and executive functioning.
|
Usual Care
n=15 Participants
Participants in the control group will receive usual services which might include primary care and prescription medications for chronic disease management.
Usual primary care services: Usual primary care services might include monitoring of vitals and other relevant laboratory testing, prescription of medications for chronic disease management, as well as counseling for lifestyle changes.
|
|---|---|---|
|
Physical Activity Level
|
-0.85 minutes
Interval -60.07 to 10.71
|
0.07 minutes
Interval -12.36 to 15.64
|
Adverse Events
IPROACTIF
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IPROACTIF
n=18 participants at risk
10 weekly sessions. First two sessions focus on comprehensive assessment of physical and executive functioning, assessment of home safety and accessibility, assessment of ADL/IADL competence and performance in context; information in these areas is used by the interventionist to collaboratively identify three patient-centered goals. Goal planning is followed by 10 treatment sessions. Treatment sessions focus on chronic disease education, problem solving issues related to disease management by modifying daily routines, recommendations for embedding physical activity in everyday tasks, and environmental modifications or activity adaptations to increase ADL/IADL independence.
IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning): IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) is an intervention designed to be delivered in primary care settings by an on-site occupational therapist. Based on the premise of preventing the physical and cognitive decline that is associated with aging and chronic disease, the 12-week intervention includes a comprehensive assessment of ADL functioning and ten intervention sessions addressing disease management, physical activity and executive functioning.
|
Usual Care
n=22 participants at risk
Participants in the control group will receive usual services which might include primary care and prescription medications for chronic disease management.
Usual primary care services: Usual primary care services might include monitoring of vitals and other relevant laboratory testing, prescription of medications for chronic disease management, as well as counseling for lifestyle changes.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
1/18 • Number of events 1 • 3 months
|
0.00%
0/22 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place