Piloting the IPROACTIF Program to Preserve Functioning and Prevent Cognitive Decline

Sponsor

University of Illinois at Chicago (Other)

Overall Status

Recruiting

CT.gov ID

NCT04682977

Collaborator

National Institute on Aging (NIA) (NIH)

Enrollment

Location

Arms

18.6

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Disease (Coronary Artery Disease, Ischemic Heart Disease, Hypertensive Heart Disease) Uncontrolled Diabetes (HBA1c ≥ 10)	Other: IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) Other: Usual primary care services	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Investigator, Outcomes Assessor)

Masking Description:

The statistician conducting data analysis will be blinded to group assignment of study participants. A numerical code will be used to identify the study arm for each participant in the outcome database. Outcome measurement will be carried out by blinded assessors at baseline and immediately post-intervention.

Primary Purpose:

Prevention

Official Title:

Piloting the IPROACTIF Program to Preserve Functioning and Prevent Cognitive Decline

Actual Study Start Date :

Aug 11, 2021

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IPROACTIF 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) 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.
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.

Arm

Intervention/Treatment

Experimental: IPROACTIF

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)

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Physical activity level [12 weeks]
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.
Self-efficacy for chronic disease management using the Chronic Disease Self-Efficacy and Self-Management Measures [12 weeks]
Self-reported assessment; range of possible scores varies by subscale; generally higher scores indicate better self-efficacy and self-management
Health related quality of life using the PROMIS Global Health Measure (physical and mental subscales) [12 weeks]
Self-reported assessment; raw scores for both sub-scales range from 4-20; higher score indicated better health-related quality of life
Participation in life activities and roles using the Late Life Functioning and Disability Index [12 weeks]
Self-rated measure; scaled scores for both dimensions (frequency and limitation) range from 0-100; higher scores indicate less difficulty i.e. better performance

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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