Direct Income SupporT and Advice Negating Spread of Epidemic COVID-19: a Randomized Controlled Trial (DISTANSE COVID)
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ClinicalTrials.gov Identifier: NCT04359264 |
Recruitment Status : Unknown
Verified July 2020 by Unity Health Toronto.
Recruitment status was: Active, not recruiting
First Posted : April 24, 2020
Last Update Posted : July 7, 2020
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Sponsor:
Unity Health Toronto
Information provided by (Responsible Party):
Unity Health Toronto
Tracking Information | |||||
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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 |
Symptoms consisent with COVID-19 [ Time Frame: 14 days ] 32-item Influenza Patient-reported Outcome (FLU-PRO) symptom score. Higher score is worse.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures |
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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 |
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Condition ICMJE | COVID-19 | ||||
Intervention ICMJE | Other: Cash transfer
Cash transfer of $1000
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Study Arms ICMJE |
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Publications * | 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. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Unity Health Toronto | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Unity Health Toronto | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Unity Health Toronto | ||||
Verification Date | July 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |