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

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.

Study Overview

• Status: Withdrawn
• Conditions: Informal Caregiver
• Intervention / Treatment: Behavioral: EMPOWER-Latinx

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Rosario Costas Muniz, PhD; Phone Number: 646-888-8062
      • Principal Investigator: Rosario Costas Muniz, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Rosairo Costas Muniz, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2022
• Primary Completion (Actual): November 7, 2023
• Study Completion (Actual): November 7, 2023

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: EMPOWER Program; Latinx Caregivers; ICU Patients; 22-141
• Other Study ID Numbers: 22-141

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No