Pilot Guaranteed Income Study, Philadelphia, April 2023

NCT05838027 | Completed Results

• 2 other identifiers: 8520285P30AG034546-14
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• Change in State Anxiety Scale

  Change from baseline in current anxiety as measured by the State Trait Anxiety Inventory subscale. The range is from 20-80 with lower scores meaning less anxiety.

  Assessed at 1-hour appointment at baseline and 3 months

• 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

• 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

• 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 Outcomes (10)

• Change in Number of Emergency Department Visits

  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.

• Change in Number of Health Care Visits (Non-emergency Department)

  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.

• Change in Cigarette Dependence Scale

  Assessed at 1-hour appointment at baseline and 3 months

• Change in Alcohol Use Scale

  Assessed at 1-hour appointment at baseline and 3 months

• Change in All Health Care Expenditures

  Assessed at 1-hour appointment at baseline and 3 months

Study Arms (2)

Control

NO INTERVENTION

No intervention

Cash Transfer

EXPERIMENTAL

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

Behavioral: Cash Transfer

Interventions

Cash Transfer BEHAVIORAL

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

Cash Transfer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to provide consent
• Non-English speaker
• Cognitive impairment, per principal investigators' discretion

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Results Point of Contact

• Title: Eva Fabian
• Organization: University of Pennsylvania

eva.fabian@pennmedicine.upenn.edu

760-791-2633

Study Officials

• Aaron Richterman, MD, MPH

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Christina A Roberto, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Harsha Thirumurthy, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: May 1, 2023
• Study Start: April 4, 2023
• Primary Completion: October 20, 2023
• Study Completion: October 20, 2023
• Last Updated: March 19, 2025
• Results First Posted: March 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)