Piloting the IPROACTIF Program to Preserve Functioning and Prevent Cognitive Decline

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.

Study Overview

• Status: Completed
• Conditions: Heart Disease (Coronary Artery Disease, Ischemic Heart Disease, Hypertensive Heart Disease); Uncontrolled Diabetes (HBA1c ≥ 10)
• Intervention / Treatment: Other: IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning); Other: Usual primary care services

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60608
      • University of Illinois at Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Usual care; 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; 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.
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Functioning Measured Using the Patient-Specific Functional Scale	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	12 weeks
Physical Functioning Measured Using the PROMIS Physical Function Short Form 20	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.	12 weeks
Physical Functioning Measured Using the Physical Performance Test (9-item)	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	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation in Life Activities and Roles Using the Late Life Functioning and Disability Index (Disability Component) - Frequency Dimension	16-item self-reported measure; scaled scores for the frequency dimension range from 0-100; higher scores indicate greater frequency i.e. better performance.	12 weeks
Participation in Life Activities and Roles Using the Late Life Functioning and Disability Index (Disability Component) - Limitations Dimension	16-item self-reported measure; scaled scores for the frequency dimension range from 0-100; higher scores indicate lesser difficulty i.e. better performance.	12 weeks
Health Related Quality of Life Using the PROMIS Global Health Measure (Physical Subscale)	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.	12 weeks
Health Related Quality of Life Using the PROMIS Global Health Measure (Mental Subscale)	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.	12 weeks
Self-efficacy Measured Using the Doing Chores Scale From the Self-Management Resource Center	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.	12 weeks
Self-efficacy Measured Using the Manage Symptoms Scale From the Self-Management Resource Center	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.	12 weeks
Self-efficacy for Chronic Disease Management Using the Obtain Help From Community, Family, Friends Scale From the Self-Management Resource Center	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	12 weeks
Self-efficacy for Chronic Disease Management Using the Manage Disease in General Scale From the Self-Management Resource Center	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	12 weeks
Self-efficacy for Chronic Disease Management Using the Social Recreational Activities Scale From the Self-Management Resource Center	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	12 weeks
Self-efficacy for Chronic Disease Management Using the Exercise Regularly Scale From the Self-Management Resource Center	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	12 weeks
Performance of Daily Living Tasks Using the Performance Assessment of Self-care Skills	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	12 weeks
Executive Functioning Using the Executive Function Performance Test	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.	12 weeks
Executive Functioning Using the Dimensional Change Card Sort Test	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.	12 weeks
Physical Activity Level	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.	12 weeks

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Mansha Mirza, PhD, OTR/L, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2021
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: December 19, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: primary care; aging; activities of daily living; physical function; executive function; chronic disease
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Cognitive Dysfunction; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: 2020-1461; 5P30AG022849-17 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No