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

Not Applicable

Withdrawn

• Conditions: Informal Caregiver
• Interventions: Behavioral: EMPOWER-Latinx

• Registration Number: NCT05589883
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-18
• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-21
• Status Verified: 2023-11
• Primary Completion: 2023-11-07
• Study Completion: 2023-11-07
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EMPOWER-Latinx intervention	EMPOWER-Latinx	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.

Primary Outcome Measures

Name	Time	Method
feasibility of EMPOWER-Latinx	1 year	Targets will include completion of 4/6 modules for feasibility.