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Piloting the IPROACTIF Program to Preserve Functioning and Prevent Cognitive Decline

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning)
Usual primary care services
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Disease (Coronary Artery Disease, Ischemic Heart Disease, Hypertensive Heart Disease) focused on measuring chronic disease, aging, physical function, executive function, activities of daily living, primary care

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

  • 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)

Sites / Locations

  • University of Illinois at ChicagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

IPROACTIF

Usual care

Arm Description

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.

Participants in the control group will receive usual services which might include primary care and prescription medications for chronic disease management.

Outcomes

Primary Outcome Measures

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
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
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
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
Executive functioning using the Dimensional Change Card Sort Test
Performance-based measure; scores range from 0-10; higher scores indicate better performance
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

Secondary Outcome Measures

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.
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
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
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

Full Information

First Posted
December 17, 2020
Last Updated
March 7, 2022
Sponsor
University of Illinois at Chicago
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04682977
Brief Title
Piloting the IPROACTIF Program to Preserve Functioning and Prevent Cognitive Decline
Official Title
Piloting the IPROACTIF Program to Preserve Functioning and Prevent Cognitive Decline
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2021 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease (Coronary Artery Disease, Ischemic Heart Disease, Hypertensive Heart Disease), Uncontrolled Diabetes (HBA1c ≥ 10)
Keywords
chronic disease, aging, physical function, executive function, activities of daily living, primary care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IPROACTIF
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
Other
Arm Description
Participants in the control group will receive usual services which might include primary care and prescription medications for chronic disease management.
Intervention Type
Other
Intervention Name(s)
IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual primary care services
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical functioning measured using the PROMIS Physical Function Short Form 20
Description
Self-reported assessment with raw scores ranging from 20 to 100; higher scores indicate better physical functioning
Time Frame
12 weeks
Title
Physical functioning measured using the Patient-Specific Functional Scale
Description
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
Time Frame
12 weeks
Title
Physical functioning measured using the Physical Performance Test (9-item)
Description
Performance-based assessment; scores can range from 0 to 36; higher scores indicate better physical functioning
Time Frame
12 weeks
Title
Performance of daily living tasks using the Performance Assessment of Self-care Skills
Description
Performance-based measure; summary score for each task ranges from 0-12; higher scores indicate better performance
Time Frame
12 weeks
Title
Executive functioning using the Dimensional Change Card Sort Test
Description
Performance-based measure; scores range from 0-10; higher scores indicate better performance
Time Frame
12 weeks
Title
Executive functioning using the Executive Function Performance Test
Description
Performance-based measure; only the medication management task will be used; scores range from 0-25 for this task; higher scores indicate poorer performance
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Physical activity level
Description
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.
Time Frame
12 weeks
Title
Self-efficacy for chronic disease management using the Chronic Disease Self-Efficacy and Self-Management Measures
Description
Self-reported assessment; range of possible scores varies by subscale; generally higher scores indicate better self-efficacy and self-management
Time Frame
12 weeks
Title
Health related quality of life using the PROMIS Global Health Measure (physical and mental subscales)
Description
Self-reported assessment; raw scores for both sub-scales range from 4-20; higher score indicated better health-related quality of life
Time Frame
12 weeks
Title
Participation in life activities and roles using the Late Life Functioning and Disability Index
Description
Self-rated measure; scaled scores for both dimensions (frequency and limitation) range from 0-100; higher scores indicate less difficulty i.e. better performance
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mansha Mirza, PhD, OTR/L
Phone
3123555427
Email
mmirza2@uic.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew DeMott, MPH
Phone
3123553174
Email
ademot1@uic.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mansha Mirza, PhD, OTR/L
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mansha Mirza, PhD, OTR/L
Phone
312-355-5427
Email
mmirza2@uic.edu
First Name & Middle Initial & Last Name & Degree
Andrew DeMott, MPH
Phone
3123553174
Email
ademot1@uic.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Piloting the IPROACTIF Program to Preserve Functioning and Prevent Cognitive Decline

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