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Lack of accrual
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMPOWER-Latinx intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMPOWER-Latinx | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| feasibility of EMPOWER-Latinx | Targets will include completion of 4/6 modules for feasibility. | 1 year |
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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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rosairo Costas Muniz, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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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.
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The design of this study is a single-arm open trial.
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