Pilot Guaranteed Income Study, Philadelphia, April 2023

NCT ID: NCT05838027

Last Updated: 2025-03-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-04

Study Completion Date

2023-10-20

Brief Summary

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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

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Cash Transfer

Participants will receive $125 every 2 weeks for 8 payments via ClinCard, for a total of $1000.

Group Type EXPERIMENTAL

Cash Transfer

Intervention Type BEHAVIORAL

Participants will receive $125 every 2 weeks for 8 payments via ClinCard, for a total of $1000.

Interventions

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Cash Transfer

Participants will receive $125 every 2 weeks for 8 payments via ClinCard, for a total of $1000.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* Unable to provide consent
* Non-English speaker
* Cognitive impairment, per principal investigators' discretion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aaron Richterman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Christina A Roberto, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Harsha Thirumurthy, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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5P30AG034546-14

Identifier Type: NIH

Identifier Source: secondary_id

View Link

852028

Identifier Type: -

Identifier Source: org_study_id

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