NCT05622903

Brief Summary

Using data from the Chelsea Eats program, we propose to study a randomized controlled trial in which the City of Chelsea, Massachusetts held a lottery to allocate cash benefits to its residents for ten months during the first two years of the COVID-19 pandemic. We will analyze the impact of the cash benefit on health care utilization and health.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,615

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 21, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

July 12, 2024

Status Verified

July 1, 2024

Enrollment Period

1.4 years

First QC Date

November 14, 2022

Last Update Submit

July 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Emergency department use

    Count of visits to the emergency department (ED) using the electronic health record

    10 months

Secondary Outcomes (10)

  • Behavioral health-related ED visit

    10 months

  • Substance use disorder-related ED visit

    10 months

  • Potentially avoidable ED visit

    10 months

  • ED visit resulting in admission to the hospital

    10 months

  • Outpatient service use

    10 months

  • +5 more secondary outcomes

Study Arms (2)

Treatment Group

EXPERIMENTAL

Participants in the treatment group received up to $400 per month.

Other: Cash Benefit

Control Group

ACTIVE COMPARATOR

Participants in the control group did not receive monthly cash benefits.

Other: No Cash Benefit

Interventions

Spending from the cards was not restricted to food but could be spent on anything and anywhere Visa was accepted. The debit cards were credited with the first payment on November 18th, 2020 and the second payment on December 18th, 2020. The program continued with monthly credits through August 2021.

Also known as: Basic Income, Debit Card
Treatment Group

No monthly cash benefit.

Control Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Resident of Chelsea, Massachusetts
  • Household income at or below 30% of the U.S. Department of Housing and Urban Development's Area Median Income

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard Medical School

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Sumit Agarwal, MD, MPH

    Brigham and Women's Hospital and Harvard Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

November 14, 2022

First Posted

November 21, 2022

Study Start

July 27, 2020

Primary Completion

December 31, 2021

Study Completion

February 1, 2024

Last Updated

July 12, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations