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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

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

Condition or disease Intervention/treatment Phase
COVID-19 Other: Cash transfer Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 392 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Direct Income SupporT and Advice Negating Spread of Epidemic COVID-19: a Randomized Controlled Trial (DISTANSE COVID-19 RCT)
Actual Study Start Date : April 20, 2020
Actual Primary Completion Date : May 29, 2020
Estimated Study Completion Date : December 30, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cash transfer Other: Cash transfer
Cash transfer of $1000
No Intervention: Control


Outcome Measures
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Primary Outcome Measures :
  1. Symptoms consisent with COVID-19 [ Time Frame: 14 days ]
    32-item Influenza Patient-reported Outcome (FLU-PRO) symptom score. Higher score is worse.


Secondary Outcome Measures :
  1. Number of close contacts [ Time Frame: Sum of contacts on days 5, 10 and 14 ]
  2. Number of participants with positive test for COVID-19 [ Time Frame: 14 days ]
  3. Self-reported health based on the single question: "In general, would you say your health is.." [ Time Frame: 14 days ]
  4. 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 Outcome Measures:
  1. Health care utilization [ Time Frame: 14 days ]
  2. Food security [ Time Frame: 14 days ]
    Three-items (worry about food running out, food did not last, balanced meals)

  3. 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?"


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04359264


Locations
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Canada, Ontario
Municipality of Assiginack Family Health Team
Assiginack, Ontario, Canada, P0P 1N0
St Michael's Hospital Academic Family Health Team
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
More Information
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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT04359264    
Other Study ID Numbers: 20-081
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No