Clinical trial NCT05838027: Pilot Guaranteed Income Study, Philadelphia, April 2023
Official title: Philly Family Trust Study: A Pilot Randomized Controlled Trial of an Unconditional Cash Transfer to Improve Health Behaviors Among Adults With Chronic Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-05-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: At the end of the baseline assessment, participants will be randomized using a permuted block technique with block size of 4 to either usual care (Arm 1) or to the unconditional cash transfer intervention (Arm 2).
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Health behaviors are major, modifiable risk factors for the development and progression of chronic diseases, which account for a large proportion of all deaths in the US and contribute to disparities in premature mortality based on both income and race. There is substantial evidence, for example, that behaviors like smoking, physical inactivity, and unhealthy diet are associated with an increased risk of cardiovascular disease (CVD), as are modifiable factors such as blood pressure, cholesterol, body mass index, and fasting glucose. A growing body of research suggests that poverty may affect health behaviors through financial and psychological pathways. However, few studies have rigorously examined the effects of poverty alleviation interventions on health behaviors, particularly among individuals at high risk for CVD. Even fewer studies have examined potential psychological mechanisms by which anti-poverty interventions might influence health behavior. This pilot project will examine the effect of unconditional cash transfers, an economic intervention that is gaining traction among policymakers, on risk factors for CVD and other chronic diseases. The project will focus on low-income adults in Philadelphia who have at least one health risk factor for CVD (diabetes/pre-diabetes and/or hypertension) and examines whether short-term, unconditional cash transfer payments result in changes in objective and self-reported health outcomes. The second aim examines potential psychological mechanisms through which the cash transfer intervention may affect study participants' behavior, including mental health, psychosocial stress, bandwidth, and future orientation. The third aim uses qualitative methods to understand participants' experiences with this study. The project activities will include developing and testing the cash transfer intervention (Stage 1) as well as basic science analysis of mechanisms of change (Stage 0).

Survey and measurement data will be collected from 100 participants at baseline and 3 month follow-up in a two-arm randomized controlled trial (50 in control, 50 in intervention). 16 participants will receive a blood pressure cuff to take home and send measurements weekly to assess the feasibility of at-home measurement (8 control, 8 intervention; half of each group will transmit wirelessly, the other half will not). 30 participants from the 3-month follow-up who are interested in doing an interview will provide additional qualitative data on their experience.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Food Security Category
timeFrame: Assessed at 1-hour appointment at baseline and 3 months
measure: Change in Utility Security Category
timeFrame: Assessed at 1-hour appointment at baseline and 3 months
measure: Change in Financial Well-being Scale
timeFrame: Assessed at 1-hour appointment at baseline and 3 months
measure: Change in Perceived Stress Scale
timeFrame: Assessed at 1-hour appointment at baseline and 3 months
measure: Change in State Anxiety Scale
timeFrame: Assessed at 1-hour appointment at baseline and 3 months
measure: Change in Mental Bandwidth
timeFrame: Assessed at 1-hour appointment at baseline and 3 months
measure: Change in Health Care Expenditures on Medications
timeFrame: Assessed at 1-hour appointment at baseline and 3 months
measure: Change in Adherence to Medication Refills Scale
timeFrame: Assessed at 1-hour appointment at baseline and 3 months
Secondary outcomes:
measure: Change in Number of Emergency Department Visits
timeFrame: 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.
measure: Change in Number of Health Care Visits (Non-emergency Department)
timeFrame: 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.
measure: Change in Cigarette Dependence Scale
timeFrame: Assessed at 1-hour appointment at baseline and 3 months
measure: Change in Alcohol Use Scale
timeFrame: Assessed at 1-hour appointment at baseline and 3 months
measure: Change in All Health Care Expenditures
timeFrame: Assessed at 1-hour appointment at baseline and 3 months
measure: Change in Time Preference (Patience)
timeFrame: Assessed at 1-hour appointment at baseline and 3 months
measure: Change in Time Preference (Behavioral Task)
timeFrame: Assessed at 1-hour appointment at baseline and 3 months
measure: Change in Psychological Distress Scale
timeFrame: Assessed at 1-hour appointment at baseline and 3 months
measure: Change in Number of Healthy Days
timeFrame: Assessed at 1-hour appointment at baseline and 3 months
measure: Change in Adherence to Taking Medications Scale
timeFrame: Assessed at 1-hour appointment at baseline and 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Aaron Richterman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Christina A Roberto, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Harsha Thirumurthy, PhD
role: PRINCIPAL_INVESTIGATOR
References: