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Completed

NCT Number: NCT04682977

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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 services

Other

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 outcomes

  1. 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

  2. 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.

  3. 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

Secondary outcomes

  1. Participation in Life Activities and Roles Using the Late Life Functioning and Disability Index (Disability Component) - Frequency Dimension

    Time frame: 12 weeks

    16-item self-reported measure; scaled scores for the frequency dimension range from 0-100; higher scores indicate greater frequency i.e. better performance.

  2. Participation in Life Activities and Roles Using the Late Life Functioning and Disability Index (Disability Component) - Limitations Dimension

    Time frame: 12 weeks

    16-item self-reported measure; scaled scores for the frequency dimension range from 0-100; higher scores indicate lesser difficulty i.e. better performance.

  3. Health Related Quality of Life Using the PROMIS Global Health Measure (Physical Subscale)

    Time frame: 12 weeks

    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.

  4. Health Related Quality of Life Using the PROMIS Global Health Measure (Mental Subscale)

    Time frame: 12 weeks

    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.

  5. Self-efficacy Measured Using the Doing Chores Scale From the Self-Management Resource Center

    Time frame: 12 weeks

    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.

  6. Self-efficacy Measured Using the Manage Symptoms Scale From the Self-Management Resource Center

    Time frame: 12 weeks

    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.

  7. 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

    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

  8. Self-efficacy for Chronic Disease Management Using the Manage Disease in General Scale From the Self-Management Resource Center

    Time frame: 12 weeks

    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

  9. Self-efficacy for Chronic Disease Management Using the Social Recreational Activities Scale From the Self-Management Resource Center

    Time frame: 12 weeks

    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

  10. Self-efficacy for Chronic Disease Management Using the Exercise Regularly Scale From the Self-Management Resource Center

    Time frame: 12 weeks

    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

  11. Performance of Daily Living Tasks Using the Performance Assessment of Self-care Skills

    Time frame: 12 weeks

    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. Executive Functioning Using the Executive Function Performance Test

    Time frame: 12 weeks

    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.

  13. Executive Functioning Using the Dimensional Change Card Sort Test

    Time frame: 12 weeks

    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.

  14. Physical Activity Level

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 24, 2020
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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