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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
45
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 might include monitoring of vitals and other relevant laboratory testing, prescription of medications for chronic disease management, as well as counseling for lifestyle changes.
University of Illinois at Chicago
Chicago, Illinois, United States
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
Time frame: 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.
Time frame: 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
Time frame: 12 weeks
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.
Time frame: 12 weeks
Participation in Life Activities and Roles Using the Late Life Functioning and Disability Index (Disability Component) - Limitations Dimension
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16-item self-reported measure; scaled scores for the frequency dimension range from 0-100; higher scores indicate lesser difficulty i.e. better performance.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks