Direct Income SupporT and Advice Negating Spread of Epidemic COVID-19: a Randomized Controlled Trial (DISTANSE COVID)

July 6, 2020 updated by: Unity Health Toronto

Direct Income SupporT and Advice Negating Spread of Epidemic COVID-19: a Randomized Controlled Trial (DISTANSE COVID-19 RCT)

This is a clinical trial of a cash transfer on symptoms consistent with COVID-19 and adherence to physical distancing guidance.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

392

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Assiginack, Ontario, Canada, P0P 1N0
        • Municipality of Assiginack Family Health Team
      • Toronto, Ontario, Canada, M5B 1W8
        • St Michael's Hospital Academic Family Health Team

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • trouble "making ends meet at the end of the month" due to COVID-19 related disruptions

Exclusion Criteria:

  • confirmed positive for COVID-19 based on laboratory testing
  • current symptoms consistent with COVID-19

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Cash transfer
Other: Cash transfer
Cash transfer of $1000

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms consisent with COVID-19
Time Frame: 14 days
32-item Influenza Patient-reported Outcome (FLU-PRO) symptom score. Higher score is worse.
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of close contacts
Time Frame: Sum of contacts on days 5, 10 and 14
Sum of contacts on days 5, 10 and 14
Number of participants with positive test for COVID-19
Time Frame: 14 days
14 days
Self-reported health based on the single question: "In general, would you say your health is.."
Time Frame: 14 days
14 days
Ability to make ends meet based on the single question: "At the end of the month, are you able to make ends meet?"
Time Frame: 14 days
14 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health care utilization
Time Frame: 14 days
14 days
Food security
Time Frame: 14 days
Three-items (worry about food running out, food did not last, balanced meals)
14 days
Cost-related medicine non-adherence
Time Frame: 14 days
Single item: "During the last two weeks, did you or any member of your household not take a medication, skip some doses, split pills or do anything else to make a medication last longer due to the cost?"
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2020

Primary Completion (Actual)

May 29, 2020

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

April 16, 2020

First Submitted That Met QC Criteria

April 21, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

July 7, 2020

Last Update Submitted That Met QC Criteria

July 6, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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