Recruiting

Observational Study

Sponsor:

Lady Davis Institute

Code:

NCT06588101

Conditions

Family Members

Recruitment

Clinical Study

Retention

Recruitment of Participants

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Written informed consent with infographic

Compensation

Study Details

Brief summary:

There is a need to identify strategies that improve the conduct of clinical trials involving family members of intensive care unit (ICU) patients. The purpose of the present study is to evaluate recruitment and retention strategies for clinical trials involving family members of ICU patients. 4 strategies (2 recruitment and 2 retention) will be tested. Investigators will integrate the strategies into three existing studies that involve family members of ICU patients. Participants will be randomized using a 2x2 factorial design. The co-primary outcomes are recruitment percentage (participants enrolled/participants approached) and retention percentage (participants completing follow-up/participants enrolled).

Conditions

Family Members

Recruitment

Clinical Study

Retention

Recruitment of Participants

Study ID

NCT06588101

Start date

May 1, 2024

Status verified date

May, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Has family member admitted to an intensive care unit.
  • Expected hospital stay > 48 hours
  • Able to participate in English or French

Exclusion Criteria:

  • Has another family member participating in the trial
  • Repeat admissions within the study period

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Both recruitment strategies

Consent form with Infographic + Large compensation

no intervention: Neither recruitment strategy

Consent form + No compensation

experimental: One recruitment strategy - Infographic

Consent form with Infographic + No compensation

experimental: One recruitment strategy - Compensation

Consent form + Large compensation

Interventions

Written informed consent with infographic

Potential participants are provided a visual infographic depicting the key elements of the written consent form in addition to the standard written consent form.

Compensation

Potential participants are provided an e-gift card to Amazon or Second Cup as a reward for completing the enrollment questionnaire.

Primary outcome measure

  • Recruitment percentage [ Time Frame: At enrolment ]
  • Retention percentage [ Time Frame: From enrolment until 6 month follow-up completion ]

Central Contacts and Locations

Central contacts

Locations

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada

Contacts

Principal Investigator:

Michael J Goldfarb, MD, MSc

More Information

Sponsor

Lady Davis Institute

Last update posted

Jun 4, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lady Davis Institute on 2025-06-04.