Heart Disease (Coronary Artery Disease, Ischemic Heart Disease, Hypertensive Heart Disease)NCT04682977
Piloting the IPROACTIF Program to Preserve Functioning and Prevent Cognitive Decline
A study testing IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) and Usual primary care services in people with Heart Disease (Coronary Artery Disease, Ischemic Heart Disease, Hypertensive Heart Disease) and Uncontrolled Diabetes (HBA1c ≥ 10), run by University of Illinois at Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Heart Disease (Coronary Artery Disease, Ischemic Heart Disease, Hypertensive Heart Disease), Uncontrolled Diabetes (HBA1c ≥ 10)
- What is being tested?
- IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) and Usual primary care services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2021to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60608
About this study
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.
Read the 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.
- Conditions
- Heart Disease (Coronary Artery Disease, Ischemic Heart Disease, Hypertensive Heart Disease), Uncontrolled Diabetes (HBA1c ≥ 10)
- Being tested
- IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning), Usual primary care services
- Keywords
- chronic disease, aging, physical function, executive function, activities of daily living, primary care
- Medical subject headings
- Heart Diseases, Coronary Artery Disease, Myocardial Ischemia, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning)Other
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.
Usual primary care servicesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| IPROACTIF | Experimental | 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. Receives: Other: IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) |
| Usual care | Other | Participants in the control group will receive usual services which might include primary care and prescription medications for chronic disease management. Receives: Other: Usual primary care services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 12 weeks
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start11 Aug 2021
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart Disease (Coronary Artery Disease, Ischemic Heart Disease, Hypertensive Heart Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Mansha Parven Mirza, University of Illinois at Chicago
- Investigators
- Mansha Mirza, PhD, OTR/L, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682977
- Sponsor's protocol ID
- 2020-1461
- Other IDs
- 5P30AG022849-17
- Status last verified
- Aug 2025
- First submitted
- 17 Dec 2020
- Last updated
- 19 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting the IPROACTIF Program to Preserve Functioning and Prevent Cognitive Decline
- ClinicalTrials.gov ID
- NCT04682977
- Acronym / sponsor ID
- 2020-1461
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Posted 19 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| IPROACTIF | Experimental | Other: IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning)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. |
| Usual care | Other | Other: Usual primary care servicesParticipants in the control group will receive usual services which might include primary care and prescription medications for chronic disease management. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | IPROACTIF |
| Usual primary care servicesUsual 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. | Other | Usual care |
Primary outcome
Physical Functioning Measured Using the Patient-Specific Functional Scale
Time frame: 12 weeks
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
Physical Functioning Measured Using the PROMIS Physical Function Short Form 20
Time frame: 12 weeks
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.
Physical Functioning Measured Using the Physical Performance Test (9-item)
Time frame: 12 weeks
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
14 secondary outcomes
Participation in Life Activities and Roles Using the Late Life Functioning and Disability Index (Disability Component) - Frequency Dimension
Time frame: 12 weeks
Participation in Life Activities and Roles Using the Late Life Functioning and Disability Index (Disability Component) - Limitations Dimension
Time frame: 12 weeks
Health Related Quality of Life Using the PROMIS Global Health Measure (Physical Subscale)
Time frame: 12 weeks
Health Related Quality of Life Using the PROMIS Global Health Measure (Mental Subscale)
Time frame: 12 weeks
Self-efficacy Measured Using the Doing Chores Scale From the Self-Management Resource Center
Time frame: 12 weeks
Self-efficacy Measured Using the Manage Symptoms Scale From the Self-Management Resource Center
Time frame: 12 weeks
Self-efficacy for Chronic Disease Management Using the Obtain Help From Community, Family, Friends Scale From the Self-Management Resource Center
Time frame: 12 weeks
Self-efficacy for Chronic Disease Management Using the Manage Disease in General Scale From the Self-Management Resource Center
Time frame: 12 weeks
Self-efficacy for Chronic Disease Management Using the Social Recreational Activities Scale From the Self-Management Resource Center
Time frame: 12 weeks
Self-efficacy for Chronic Disease Management Using the Exercise Regularly Scale From the Self-Management Resource Center
Time frame: 12 weeks
Performance of Daily Living Tasks Using the Performance Assessment of Self-care Skills
Time frame: 12 weeks
Executive Functioning Using the Executive Function Performance Test
Time frame: 12 weeks
Executive Functioning Using the Dimensional Change Card Sort Test
Time frame: 12 weeks
Physical Activity Level
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mansha Mirza, PhD, OTR/L principal investigator
University of Illinois at Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) and Usual primary care services in people with Heart Disease (Coronary Artery Disease, Ischemic Heart Disease, Hypertensive Heart Disease) and Uncontrolled Diabetes (HBA1c ≥ 10), run by University of Illinois at Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Functioning Measured Using the Patient-Specific Functional Scale (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025; AzTrials last refreshed its copy on 26 Oct 2026.