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

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Feasibility of the Cultural Adaptation of EMPOWER for Latinx Informal Caregivers in Intensive Care Units in the Context of COVID-19

Conditions
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Informal Caregiver

Intervention / Treatment
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* Behavioral: EMPOWER-Latinx


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: The design of this study is a single-arm open trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EMPOWER-Latinx intervention<br>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. | Behavioral: EMPOWER-Latinx<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility of EMPOWER-Latinx | Targets will include completion of 4/6 modules for feasibility. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EMPOWER Program, Latinx Caregivers, ICU Patients, 22-141