Heart Disease (Coronary Artery Disease, Ischemic Heart Disease, Hypertensive Heart Disease) Clinical Trial
Official title:
Piloting the IPROACTIF Program to Preserve Functioning and Prevent Cognitive Decline
| Verified date | June 2024 |
| Source | University of Illinois at Chicago |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 45 |
| Est. completion date | March 1, 2024 |
| Est. primary completion date | March 1, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 55 Years and older |
| Eligibility | 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 - 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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Illinois at Chicago | Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| University of Illinois at Chicago | National Institute on Aging (NIA) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | Executive functioning using the Dimensional Change Card Sort Test | Performance-based measure; scores range from 0-10; higher scores indicate better performance | 12 weeks | |
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |