Cardiovascular DiseasesPGINCT05838027
Pilot Guaranteed Income Study, Philadelphia, April 2023
A study testing Cash Transfer in people with Cardiovascular Diseases, run by University of Pennsylvania at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Cash Transfer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2023to 20 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Does not meet all of the inclusion criteria
- Unable to provide consent
- Non-English speaker
- Cognitive impairment, per principal investigators' discretion
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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
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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Cash Transfer
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cash TransferBehavioural
Participants will receive $125 every 2 weeks for 8 payments via ClinCard, for a total of $1000.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cash Transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: Assessed at 1-hour appointment at baseline and 3 months
Secondary outcomes (10)
Change in Number of Emergency Department Visits
We had initially hoped to descriptively summarize these outcomes as part of this pilot study, but the staff member leading our analyses departed during the course of this study and we no longer had someone with the skills and bandwidth to pull, merge, and analyze these data from the electronic health record. For that reason, the data were never collected in this sample and so we have not reported these outcomes
Measured: 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)
We had initially hoped to descriptively summarize these outcomes as part of this pilot study, but the staff member leading our analyses departed during the course of this study and we no longer had someone with the skills and bandwidth to pull, merge, and analyze these data from the electronic health record. For that reason, the data were never collected in this sample and so we have not reported these outcomes
Measured: 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
Change from baseline in current cigarette dependence as measured by the Cigarette Dependence Scale (short version; 5-25, higher scores indicate more dependence).
Measured: Assessed at 1-hour appointment at baseline and 3 months
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).
Measured: Assessed at 1-hour appointment at baseline and 3 months
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.
Measured: Assessed at 1-hour appointment at baseline and 3 months
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).
Measured: Assessed at 1-hour appointment at baseline and 3 months
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).
Measured: Assessed at 1-hour appointment at baseline and 3 months
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).
Measured: Assessed at 1-hour appointment at baseline and 3 months
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).
Measured: Assessed at 1-hour appointment at baseline and 3 months
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).
Measured: Assessed at 1-hour appointment at baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start4 Apr 2023
- Primary completion20 Oct 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Aaron Richterman, MD, MPH, Principal investigator, University of PennsylvaniaChristina A Roberto, PhD, Principal investigator, University of PennsylvaniaHarsha Thirumurthy, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838027
- Sponsor's protocol ID
- 852028
- Other IDs
- 5P30AG034546-14
- Acronym
- PGI
- Status last verified
- Feb 2025
- First submitted
- 3 Apr 2023
- Last updated
- 19 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05838027
- Acronym / sponsor ID
- PGI / 852028
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 1 May 2023 (actual)
- Results
- Posted 19 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention |
| Cash Transfer | Experimental | Behavioral: Cash TransferParticipants will receive $125 every 2 weeks for 8 payments via ClinCard, for a total of $1000. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Does not meet all of the inclusion criteria
- Unable to provide consent
- Non-English speaker
- Cognitive impairment, per principal investigators' discretion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cash TransferParticipants will receive $125 every 2 weeks for 8 payments via ClinCard, for a total of $1000. | Behavioural | Cash Transfer |
Primary outcome
Change in Food Security Category
Time frame: Assessed at 1-hour appointment at baseline and 3 months
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.
Change in Utility Security Category
Time frame: Assessed at 1-hour appointment at baseline and 3 months
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.
Change in Financial Well-being Scale
Time frame: Assessed at 1-hour appointment at baseline and 3 months
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).
Change in Perceived Stress Scale
Time frame: Assessed at 1-hour appointment at baseline and 3 months
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).
Change in State Anxiety Scale
Time frame: Assessed at 1-hour appointment at baseline and 3 months
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.
Change in Mental Bandwidth
Time frame: Assessed at 1-hour appointment at baseline and 3 months
Change from baseline in number of lapses in the Psychomotor Vigilance Task (more lapses indicate less mental bandwidth).
Change in Health Care Expenditures on Medications
Time frame: Assessed at 1-hour appointment at baseline and 3 months
Change from baseline in number of dollars spent out-of-pocket on medications in the past 30 days.
Change in Adherence to Medication Refills Scale
Time frame: Assessed at 1-hour appointment at baseline and 3 months
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).
10 secondary outcomes
Change in Number of Emergency Department Visits
Time frame: 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)
Time frame: 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
Time frame: Assessed at 1-hour appointment at baseline and 3 months
Change in Alcohol Use Scale
Time frame: Assessed at 1-hour appointment at baseline and 3 months
Change in All Health Care Expenditures
Time frame: Assessed at 1-hour appointment at baseline and 3 months
Change in Time Preference (Patience)
Time frame: Assessed at 1-hour appointment at baseline and 3 months
Change in Time Preference (Behavioral Task)
Time frame: Assessed at 1-hour appointment at baseline and 3 months
Change in Psychological Distress Scale
Time frame: Assessed at 1-hour appointment at baseline and 3 months
Change in Number of Healthy Days
Time frame: Assessed at 1-hour appointment at baseline and 3 months
Change in Adherence to Taking Medications Scale
Time frame: Assessed at 1-hour appointment at baseline and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Richterman, MD, MPH principal investigator
University of Pennsylvania
Christina A Roberto, PhD principal investigator
University of Pennsylvania
Harsha Thirumurthy, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cash Transfer in people with Cardiovascular Diseases, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Food Security Category (time frame: Assessed at 1-hour appointment at baseline and 3 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.