Piloting the IPROACTIF Program to Preserve Functioning and Prevent Cognitive Decline

Study Overview
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Brief Summary
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Conduct a pilot randomized control to assess the preliminary efficacy of IPROACTIF, an occupational therapist-delivered primary care intervention for aging and chronic disease management.

Detailed Description
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The IPROACTIF intervention is 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. This pilot randomized control trial will compare whether patients who receive IPROACTIF perform better than usual care patients on physical functioning, self-efficacy for chronic disease management, physical activity levels, executive functioning, health-related quality of life, and participation in life roles and activities.

Official Title
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Piloting the IPROACTIF Program to Preserve Functioning and Prevent Cognitive Decline

Conditions
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Heart Disease (Coronary Artery Disease, Ischemic Heart Disease, Hypertensive Heart Disease), Uncontrolled Diabetes (HBA1c ≥ 10)

Intervention / Treatment
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* Other: IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning)
* Other: Usual primary care services


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English speaking Community-dwelling 55 years of age Primary diagnosis of heart disease (coronary artery disease, ischemic heart disease, hypertensive heart disease), or uncontrolled diabetes (HBA1c greater than/equal to 10) Self-reported risk of functional decline (score of 3 or higher) on the 11-item Brief Risk Identification of Geriatric Health Tool or self-reported need for assistance with disease management Exclusion Criteria Current/past diagnosis of stroke or other neurological disorders Receiving pharmacological treatment for cognition Receiving outpatient rehabilitation services Participating in other exercise or ADL-focused intervention studies Non-English speaking Residing in a long-term care institution Compromised decision-making capacity (score >8 on SOMCT)

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to receive the IPROACTIF intervention or usual primary care services. Stratified randomization will be carried out with each diagnostic category (diabetes and heart disease) serving as a stratum.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPROACTIF<br>12 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. | Other: IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning)<br>* 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.<br>|
| Other: Usual care<br>Participants in the control group will receive usual services which might include primary care and prescription medications for chronic disease management. | Other: Usual primary care services<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical functioning measured using the PROMIS Physical Function Short Form 20 | Self-reported assessment with raw scores ranging from 20 to 100; higher scores indicate better physical functioning | 12 weeks | 
| Physical functioning measured using the Patient-Specific Functional Scale | Self-reported assessment; scoring depends on number of activities rated, for a single activity, scores can range from 0 to 10; higher scores indicate better physical functioning | 12 weeks | 
| Physical functioning measured using the Physical Performance Test (9-item) | Performance-based assessment; scores can range from 0 to 36; higher scores indicate better physical functioning | 12 weeks | 
| Performance of daily living tasks using the Performance Assessment of Self-care Skills | Performance-based measure; summary score for each task ranges from 0-12; higher scores indicate better performance | 12 weeks | 
| Executive functioning using the Dimensional Change Card Sort Test | Performance-based measure; scores range from 0-10; higher scores indicate better performance | 12 weeks | 
| Executive functioning using the Executive Function Performance Test | Performance-based measure; only the medication management task will be used; scores range from 0-25 for this task; higher scores indicate poorer performance | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity level | Total minutes per day in moderate to vigorous physical activity and sedentary activity as measured by an accelerometer worn for at least 12 hours over seven consecutive days. | 12 weeks | 
| Self-efficacy for chronic disease management using the Chronic Disease Self-Efficacy and Self-Management Measures | Self-reported assessment; range of possible scores varies by subscale; generally higher scores indicate better self-efficacy and self-management | 12 weeks | 
| Health related quality of life using the PROMIS Global Health Measure (physical and mental subscales) | Self-reported assessment; raw scores for both sub-scales range from 4-20; higher score indicated better health-related quality of life | 12 weeks | 
| Participation in life activities and roles using the Late Life Functioning and Disability Index | Self-rated measure; scaled scores for both dimensions (frequency and limitation) range from 0-100; higher scores indicate less difficulty i.e. better performance | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic disease, aging, physical function, executive function, activities of daily living, primary care