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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04359264
Recruitment Status : Active, not recruiting
First Posted : April 24, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Tracking Information
First Submitted Date  ICMJE April 16, 2020
First Posted Date  ICMJE April 24, 2020
Last Update Posted Date July 7, 2020
Actual Study Start Date  ICMJE April 20, 2020
Actual Primary Completion Date May 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2020)		 Symptoms consisent with COVID-19 [ Time Frame: 14 days ]
32-item Influenza Patient-reported Outcome (FLU-PRO) symptom score. Higher score is worse.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2020)
  • Number of close contacts [ Time Frame: Sum of contacts on days 5, 10 and 14 ]
  • Number of participants with positive test for COVID-19 [ Time Frame: 14 days ]
  • Self-reported health based on the single question: "In general, would you say your health is.." [ Time Frame: 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 21, 2020)
  • Health care utilization [ Time Frame: 14 days ]
  • Food security [ Time Frame: 14 days ]
    Three-items (worry about food running out, food did not last, balanced meals)
  • 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?"
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Direct Income SupporT and Advice Negating Spread of Epidemic COVID-19: a Randomized Controlled Trial
Official Title  ICMJE Direct Income SupporT and Advice Negating Spread of Epidemic COVID-19: a Randomized Controlled Trial (DISTANSE COVID-19 RCT)
Brief Summary This is a clinical trial of a cash transfer on symptoms consistent with COVID-19 and adherence to physical distancing guidance.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE Other: Cash transfer
Cash transfer of $1000
Study Arms  ICMJE
  • Experimental: Cash transfer
    Intervention: Other: Cash transfer
  • No Intervention: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 21, 2020)		 392
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Actual Primary Completion Date May 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04359264
Other Study ID Numbers  ICMJE 20-081
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party St. Michael's Hospital, Toronto
Study Sponsor  ICMJE St. Michael's Hospital, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account St. Michael's Hospital, Toronto
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP