Study Stopped
Lack of accrual
A Study of the EMPOWER Program for Latinx Caregivers of ICU Patients
Pilot Feasibility of the Cultural Adaptation of EMPOWER for Latinx Informal Caregivers in Intensive Care Units in the Context of COVID-19
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The researchers are doing this study to find out whether EMPOWER (Enhancing \& Mobilizing the Potential for Wellness \& Emotional Resilience) may reduce emotional distress in Latinx caregivers of patients in the ICU.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2022
CompletedStudy Start
First participant enrolled
October 18, 2022
CompletedFirst Posted
Study publicly available on registry
October 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 7, 2023
CompletedNovember 9, 2023
November 1, 2023
1.1 years
October 18, 2022
November 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
feasibility of EMPOWER-Latinx
Targets will include completion of 4/6 modules for feasibility.
1 year
Study Arms (1)
EMPOWER-Latinx intervention
EXPERIMENTALInformal caregivers will meet with the interventionist one-on-one via telepsychiatry (e.g., WebEx, Zoom) for 6, 15-20 minute modules to be completed within about 2-3 days from initiation of the first module, not including the booster modules. Informal caregivers will complete study assessments as per the schedule of assessments.
Interventions
EMPOWER-Latinx will be delivered in Spanish by videoconferencing (i.e., Zoom, WebEx) with a trained study interventionist. Intervention modules will be audio- and video-recorded (videorecording optional).
Eligibility Criteria
You may qualify if:
- Informal caregivers of patients, who were admitted in an ICU or step-down unit during their current admission/stay or within 2 weeks of discharge from their last admission/stay.
- Informal caregivers listed as a designated health care proxy or decision-making patient surrogate by ICU medical staff.
- Age 18 years or older as per self-report.
- Residing in New York or New Jersey as per self-report or able to complete modules while complying with current telehealth regulations.
- Spanish-speaking as per the Spanish language assessment items below and willing to receive the intervention in Spanish.
- What is the participant's preferred language?
- (Specify Lang)\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
- How well does the participant speak Spanish?
- Very well (PARTICIPANT IS ELIGIBLE)
- Well (PARTICIPANT is ELIGIBLE)
- Not well (PARTICIPANT is NOT ELIGIBLE)
- Not at all (PARTICIPANT is NOT ELIGIBLE)
You may not qualify if:
- Informal caregivers who score low, moderate or high on the Columbia Suicide Severity Rating Scale.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Rosairo Costas Muniz, PhD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2022
First Posted
October 21, 2022
Study Start
October 18, 2022
Primary Completion
November 7, 2023
Study Completion
November 7, 2023
Last Updated
November 9, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.