Cardiovascular Diseases Clinical Trial
— PGIOfficial title:
Philly Family Trust Study: A Pilot Randomized Controlled Trial of an Unconditional Cash Transfer to Improve Health Behaviors Among Adults With Chronic Diseases
Verified date | January 2024 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this pilot clinical trial is to learn about the effects of a short-term unconditional cash transfer (UCT) in people living with poverty and chronic disease (either prediabetes/diabetes or hypertension). The main questions it aims to answer are: - How feasible and acceptable is the intervention? - How are key health behaviors and outcomes affected by the intervention? - What are reasonable effect sizes to expect in a larger trial? Participants will complete surveys and health measurements at two timepoints 3 months apart. Half of the participants will be randomly assigned to the treatment where they will receive a UCT of $1000 over 4 months. Researchers will compare the treatment group to the control group to see if there are improvements in health risk factors directly related to insufficient resources (food and utility security, stress-levels, mental bandwidth), financial outcomes, and health behaviors.
Status | Completed |
Enrollment | 100 |
Est. completion date | October 20, 2023 |
Est. primary completion date | October 20, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age 18 years or greater - Pennsylvania Medicaid enrollee - At least one recent clinic visit at Penn Family Care (earliest six months before start of recruitment) - Diagnosis of pre-diabetes/diabetes and/or hypertension - Actively prescribed a medication for diabetes or hypertension - Regular resident of the Philadelphia metro area without plans to leave in the next 6 months Exclusion Criteria: - Does not meet all of the inclusion criteria - Unable to provide consent - Non-English speaker - Cognitive impairment, per principal investigators' discretion |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in food security category | Change from baseline in food security in the last 30 days as measured by the US Department of Agriculture food security scale. Outcome is 3 ordered categories: high or marginal food security, low food security, very low food security. | Assessed at 1-hour appointment at baseline and 3 months | |
Primary | Change in utility security category | Change from baseline in utility security in the last 3 months as measured by the Home Energy Insecurity scale. Outcome is 5 ordered categories: thriving, capable, stable, vulnerable, in-crisis. | Assessed at 1-hour appointment at baseline and 3 months | |
Primary | Change in financial well-being scale | Change from baseline in current financial well-being as measured by the Consumer Financial Protection Bureau Financial Well-Being 0-100 scale (higher scores are correlated to more well-being). | Assessed at 1-hour appointment at baseline and 3 months | |
Primary | Change in perceived stress scale | Change from baseline in perceived stress in the last 30 days as measured by the Perceived Stress Scale (short form; 0-16, higher scores are correlated to more stress). | Assessed at 1-hour appointment at baseline and 3 months | |
Primary | Change in state anxiety scale | Change from baseline in current anxiety as measured by the State Trait Anxiety Inventory (20-items reverse-coded and summed according to the manual, higher scores are correlated to more anxiety). | Assessed at 1-hour appointment at baseline and 3 months | |
Primary | Change in mental bandwidth | Change from baseline in number of lapses in the Psychomotor Vigilance Task (more lapses indicate less mental bandwidth). | Assessed at 1-hour appointment at baseline and 3 months | |
Primary | Change in health care expenditures on medications | Change from baseline in number of dollars spent out-of-pocket on medications in the past 30 days. | Assessed at 1-hour appointment at baseline and 3 months | |
Primary | Change in adherence to medication refills scale | Change from baseline in current adherence to refilling medications as measured by that subscale of the Adherence to Refills and Medications Scale (ARMS; 4-16, higher scores indicate lower adherence). | Assessed at 1-hour appointment at baseline and 3 months | |
Secondary | Change in number of emergency department visits | Change from baseline in number of emergency department visits in the prior 3 months as recorded in the Electronic Health Record. | Once all study appointments are completed, ED visit data will be collected through the Data Analytics Center for the 3-month period before baseline, and the 3-month period after baseline. | |
Secondary | Change in number of health care visits (non-emergency department) | Change from baseline in number of non-emergency department visits in the prior 3 months as recorded in the Electronic Health Record. | Once all study appointments are completed, number of health care visits(non-ED) data will be collected through the Data Analytics Center for the 3-month period before baseline, and the 3-month period after baseline. | |
Secondary | Change in cigarette dependence scale | Change from baseline in current cigarette dependence as measured by the Cigarette Dependence Scale (short version; 5-25, higher scores indicate more dependence). | Assessed at 1-hour appointment at baseline and 3 months | |
Secondary | Change in alcohol use scale | Change from baseline in current alcohol use as measured by the Alcohol Use Disorders Identification Test (0-12, higher scores indicate more use). | Assessed at 1-hour appointment at baseline and 3 months | |
Secondary | Change in all health care expenditures | Change from baseline in sum of dollars spent out-of-pocket on medications, office visits, and emergency room visits in the past 30 days. | Assessed at 1-hour appointment at baseline and 3 months | |
Secondary | Change in time preference (patience) | Change from baseline on current patience which is a single item in the Preference Survey Module (0 "completely unwilling" to 10 "completely willing" to give up present benefits for future benefits, higher scores indicate future preference). | Assessed at 1-hour appointment at baseline and 3 months | |
Secondary | Change in time preference (behavioral task) | Change from baseline on current snack choice (binary: chose a more or a less healthy snack, choosing a healthy snack indicates future preference). | Assessed at 1-hour appointment at baseline and 3 months | |
Secondary | Change in psychological distress scale | Change from baseline in psychological distress in the past 30 days as measured by the Kessler Psychological Distress Scale (K6+, 6-30, higher scores indicate more distress). | Assessed at 1-hour appointment at baseline and 3 months | |
Secondary | Change in number of healthy days | Change from baseline in self-reported number of healthy days in the past 30 as measured by the CDC Health-Related Quality of Life Scale (0-30 days). | Assessed at 1-hour appointment at baseline and 3 months | |
Secondary | Change in adherence to taking medications scale | Change from baseline in current adherence to taking medications as measured by that subscale of the Adherence to Refills and Medications Scale (ARMS; 8-32, higher scores indicate lower adherence). | Assessed at 1-hour appointment at baseline and 3 months |
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