Back to resultsDirect Income SupporT and Advice Negating Spread of Epidemic COVID-19: a Randomized Controlled Trial (DISTANSE COVID)
Primary Purpose
COVID-19
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cash transfer
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19
Eligibility Criteria
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
Sites / Locations
- Municipality of Assiginack Family Health Team
- St Michael's Hospital Academic Family Health Team
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cash transfer
Control
Arm Description
Outcomes
Primary Outcome Measures
Symptoms consisent with COVID-19
32-item Influenza Patient-reported Outcome (FLU-PRO) symptom score. Higher score is worse.
Secondary Outcome Measures
Number of close contacts
Number of participants with positive test for COVID-19
Self-reported health based on the single question: "In general, would you say your health is.."
Ability to make ends meet based on the single question: "At the end of the month, are you able to make ends meet?"
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04359264
Brief Title
Direct Income SupporT and Advice Negating Spread of Epidemic COVID-19: a Randomized Controlled Trial
Acronym
DISTANSE COVID
Official Title
Direct Income SupporT and Advice Negating Spread of Epidemic COVID-19: a Randomized Controlled Trial (DISTANSE COVID-19 RCT)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2020 (Actual)
Primary Completion Date
May 29, 2020 (Actual)
Study Completion Date
December 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a clinical trial of a cash transfer on symptoms consistent with COVID-19 and adherence to physical distancing guidance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
392 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cash transfer
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Cash transfer
Intervention Description
Cash transfer of $1000
Primary Outcome Measure Information:
Title
Symptoms consisent with COVID-19
Description
32-item Influenza Patient-reported Outcome (FLU-PRO) symptom score. Higher score is worse.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Number of close contacts
Time Frame
Sum of contacts on days 5, 10 and 14
Title
Number of participants with positive test for COVID-19
Time Frame
14 days
Title
Self-reported health based on the single question: "In general, would you say your health is.."
Time Frame
14 days
Title
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
Other Pre-specified Outcome Measures:
Title
Health care utilization
Time Frame
14 days
Title
Food security
Description
Three-items (worry about food running out, food did not last, balanced meals)
Time Frame
14 days
Title
Cost-related medicine non-adherence
Description
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?"
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Municipality of Assiginack Family Health Team
City
Assiginack
State/Province
Ontario
ZIP/Postal Code
P0P 1N0
Country
Canada
Facility Name
St Michael's Hospital Academic Family Health Team
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34924360
Citation
Persaud N, Thorpe KE, Bedard M, Hwang SW, Pinto A, Juni P, da Costa BR; DISTANSE COVID-19 (Direct Income SupporT and Advice Negating Spread of Epidemic COVID-19: a randomized controlled trial) study team. Cash transfer during the COVID-19 pandemic: a multicentre, randomised controlled trial. Fam Med Community Health. 2021 Dec;9(4):e001452. doi: 10.1136/fmch-2021-001452.
Results Reference
derived
Learn more about this trial
Direct Income SupporT and Advice Negating Spread of Epidemic COVID-19: a Randomized Controlled Trial
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