Informal CaregiverNCT05589883
A Study of the EMPOWER Program for Latinx Caregivers of ICU Patients
A study testing EMPOWER-Latinx in people with Informal Caregiver, run by Memorial Sloan Kettering Cancer Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Informal Caregiver
- What is being tested?
- EMPOWER-Latinx
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 18 Oct 2022to 7 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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?
Show all 12Show fewer
- (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)
Who cannot join
- Informal caregivers who score low, moderate or high on the Columbia Suicide Severity Rating Scale.
About this study
Official title: 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.
- Conditions
- Informal Caregiver
- Being tested
- EMPOWER-Latinx
- Keywords
- EMPOWER Program, Latinx Caregivers, ICU Patients, 22-141
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMPOWER-LatinxBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: EMPOWER-Latinx |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of EMPOWER-Latinx
Targets will include completion of 4/6 modules for feasibility.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start18 Oct 2022
- Primary completion7 Nov 2023
- Study completion7 Nov 2023
Why it stopped: Lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Informal CaregiverStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The design of this study is a single-arm open trial.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Devika Jutagir, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589883
- Sponsor's protocol ID
- 22-141
- Status last verified
- Aug 2026
- First submitted
- 18 Oct 2022
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility of the Cultural Adaptation of EMPOWER for Latinx Informal Caregivers in Intensive Care Units in the Context of COVID-19
- ClinicalTrials.gov ID
- NCT05589883
- Acronym / sponsor ID
- 22-141
- Conditions
- Informal Caregiver
- Keywords
- EMPOWER Program, Latinx Caregivers, ICU Patients, 22-141
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 7 Nov 2023 (actual)
- Study completion
- 7 Nov 2023 (actual)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The design of this study is a single-arm open trial.
| Arm | Type | Receives |
|---|---|---|
| EMPOWER-Latinx intervention | Experimental | Behavioral: EMPOWER-LatinxInformal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (1 listed)
- Informal caregivers who score low, moderate or high on the Columbia Suicide Severity Rating Scale.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMPOWER-LatinxEMPOWER-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). | Behavioural | EMPOWER-Latinx intervention |
Primary outcome
feasibility of EMPOWER-Latinx
Time frame: 1 year
Targets will include completion of 4/6 modules for feasibility.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Devika Jutagir, PhD principal investigator
Memorial Sloan Kettering Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing EMPOWER-Latinx in people with Informal Caregiver, run by Memorial Sloan Kettering Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility of EMPOWER-Latinx (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.