A Study of the EMPOWER Program for Latinx Caregivers of ICU Patients

NCT ID: NCT05589883

Last Updated: 2023-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-18

Study Completion Date

2023-11-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Informal Caregiver

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

The design of this study is a single-arm open trial.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EMPOWER-Latinx intervention

Informal 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.

Group Type EXPERIMENTAL

EMPOWER-Latinx

Intervention Type BEHAVIORAL

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EMPOWER-Latinx

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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)

Exclusion Criteria

* Informal caregivers who score low, moderate or high on the Columbia Suicide Severity Rating Scale.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rosairo Costas Muniz, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Related Links

Access external resources that provide additional context or updates about the study.

http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

22-141

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.