NCT04359264

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
392

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

April 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

1 month

First QC Date

April 16, 2020

Last Update Submit

July 6, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Symptoms consisent with COVID-19

    32-item Influenza Patient-reported Outcome (FLU-PRO) symptom score. Higher score is worse.

    14 days

Secondary Outcomes (4)

  • Number of close contacts

    Sum of contacts on days 5, 10 and 14

  • Number of participants with positive test for COVID-19

    14 days

  • Self-reported health based on the single question: "In general, would you say your health is.."

    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?"

    14 days

Other Outcomes (3)

  • Health care utilization

    14 days

  • Food security

    14 days

  • Cost-related medicine non-adherence

    14 days

Study Arms (2)

Cash transfer

EXPERIMENTAL
Other: Cash transfer

Control

NO INTERVENTION

Interventions

Cash transfer of $1000

Cash transfer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Municipality of Assiginack Family Health Team

Assiginack, Ontario, P0P 1N0, Canada

Location

St Michael's Hospital Academic Family Health Team

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 24, 2020

Study Start

April 20, 2020

Primary Completion

May 29, 2020

Study Completion

December 30, 2020

Last Updated

July 7, 2020

Record last verified: 2020-07

Locations