NCT06024278

Brief Summary

The investigators hypothesize that culturally based educational videos for Puerto Rican and African American home hospice caregivers will better inform caregivers in managing symptoms, preparedness, self-efficacy, and competence.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2024

Completed
10 months until next milestone

Results Posted

Study results publicly available

December 11, 2024

Completed
Last Updated

December 11, 2024

Status Verified

November 1, 2024

Enrollment Period

9 months

First QC Date

August 29, 2023

Results QC Date

October 15, 2024

Last Update Submit

November 15, 2024

Conditions

Caregivers of Patients on Hospice Care

Outcome Measures

Primary Outcomes (32)

  • Caregivers' Comfort in Managing Shortness of Breath as Assessed by a Likert Scale at Pre-Intervention

    Question ranges from 1 (Extremely uncomfortable) to 5 (Very comfortable)

    Pre-intervention at Day 1

  • Caregivers' Comfort in Managing Shortness of Breath as Assessed by a Likert Scale at Post-Intervention

    Question ranges from 1 (Extremely uncomfortable) to 5 (Very comfortable)

    Post-intervention at Day 1

  • Caregivers' Knowledge in Delivering Liquid Medication as Assessed by a Likert Scale at Pre-Intervention

    Question ranges from 1 (No knowledge) to 5 (Very knowledgeable)

    Pre-intervention at Day 1

  • Caregivers' Knowledge in Delivering Liquid Medication as Assessed by a Likert Scale at Post-Intervention

    Question ranges from 1 (No knowledge) to 5 (Very knowledgeable)

    Post-intervention at Day 1

  • Caregivers' Knowledge in Caregiver Resources in Hospice as Assessed by a Likert Scale at Pre-Intervention

    Question ranges from 1 (No knowledge) to 5 (Very knowledgeable)

    Pre-intervention at Day 1

  • Caregivers' Knowledge in Caregiver Resources in Hospice as Assessed by a Likert Scale at Post-Intervention

    Question ranges from 1 (No knowledge) to 5 (Very knowledgeable)

    Post-intervention at Day 1

  • Caregivers' Comfort in Using Opioids to Treat Pain as Assessed by a Likert Scale at Pre-Intervention

    Question ranges from 1 (Extremely uncomfortable) to 5 (Very comfortable)

    Pre-intervention at Day 1

  • Caregivers' Comfort in Using Opioids to Treat Pain as Assessed by a Likert Scale at Post-Intervention

    Question ranges from 1 (Extremely uncomfortable) to 5 (Very comfortable)

    Post-intervention at Day 1

  • Caregivers' Knowledge in Turning a Patient in Bed as Assessed by a Likert Scale at Pre-Intervention

    Question ranges from 1 (No knowledge) to 5 (Very knowledgeable)

    Pre-intervention at Day 1

  • Caregivers' Knowledge in Turning a Patient in Bed as Assessed by a Likert Scale at Post-Intervention

    Question ranges from 1 (No knowledge) to 5 (Very knowledgeable)

    Post-intervention at Day 1

  • Caregivers' Knowledge in Recognizing Patients' Agitation and Confusion as Assessed by a Likert Scale at Pre-Intervention

    Question ranges from 1 (No knowledge) to 5 (Very knowledgeable)

    Pre-intervention at Day 1

  • Caregivers' Knowledge in Recognizing Patients' Agitation and Confusion as Assessed by a Likert Scale at Post-Intervention

    Question ranges from 1 (No knowledge) to 5 (Very knowledgeable)

    Post-intervention at Day 1

  • Caregivers' Knowledge in Recognizing End-of-life Signs and Symptoms as Assessed by a Likert Scale at Pre-Intervention

    Question ranges from 1 (No knowledge) to 5 (Very knowledgeable)

    Pre-intervention at Day 1

  • Caregivers' Knowledge in Recognizing End-of-life Signs and Symptoms as Assessed by a Likert Scale at Post-Intervention

    Question ranges from 1 (No knowledge) to 5 (Very knowledgeable)

    Post-intervention at Day 1

  • Caregivers' Comfort in Managing Shortness of Breath Related to Anxiety as Assessed by a Likert Scale at Pre-Intervention

    Question ranges from 1 (Extremely uncomfortable) to 5 (Very comfortable)

    Pre-intervention at Day 1

  • Caregivers' Comfort in Managing Shortness of Breath Related to Anxiety as Assessed by a Likert Scale at Post-Intervention

    Question ranges from 1 (Extremely uncomfortable) to 5 (Very comfortable)

    Post-intervention at Day 1

  • Caregivers' Knowledge About Spiritual Resources in Hospice Care as Assessed by a Likert Scale at Pre-Intervention

    Question ranges from 1 (No knowledge) to 5 (Very knowledgeable)

    Pre-intervention at Day 1

  • Caregivers' Knowledge About Spiritual Resources in Hospice Care as Assessed by a Likert Scale at Post-Intervention

    Question ranges from 1 (No knowledge) to 5 (Very knowledgeable)

    Post-intervention at Day 1

  • Caregivers' Comfort in Using Opioids Like Morphine to Help Ease Shortness of Breath as Assessed by a Likert Scale at Pre-Intervention

    Question ranges from 1 (Extremely uncomfortable) to 5 (Very comfortable)

    Pre-intervention at Day 1

  • Caregivers' Comfort in Using Opioids Like Morphine to Help Ease Shortness of Breath as Assessed by a Likert Scale at Post-Intervention

    Question ranges from 1 (Extremely uncomfortable) to 5 (Very comfortable)

    Post-intervention at Day 1

  • Caregivers' Comfort in Managing Nausea as Assessed by a Likert Scale at Pre-Intervention

    Question ranges from 1 (Extremely uncomfortable) to 5 (Very comfortable)

    Pre-intervention at Day 1

  • Caregivers' Comfort in Managing Nausea as Assessed by a Likert Scale at Post-Intervention

    Question ranges from 1 (Extremely uncomfortable) to 5 (Very comfortable)

    Post-intervention at Day 1

  • Caregivers' Comfort in Managing Constipation as Assessed by a Likert Scale at Pre-Intervention

    Question ranges from 1 (Extremely uncomfortable) to 5 (Very comfortable)

    Pre-intervention at Day 1

  • Caregivers' Comfort in Managing Constipation as Assessed by a Likert Scale at Post-Intervention

    Question ranges from 1 (Extremely uncomfortable) to 5 (Very comfortable)

    Post-intervention at Day 1

  • Caregivers' Knowledge About Recognizing Caregiver Stress as Assessed by a Likert Scale at Pre-Intervention

    Question ranges from 1 (No knowledge) to 5 (Very knowledgeable)

    Pre-intervention at Day 1

  • Caregivers' Knowledge About Recognizing Caregiver Stress as Assessed by a Likert Scale at Post-Intervention

    Question ranges from 1 (No knowledge) to 5 (Very knowledgeable)

    Post-intervention at Day 1

  • Caregivers' Comfort in Coping With Lack of Appetite for Someone at the End of Life as Assessed by a Likert Scale at Pre-Intervention

    Question ranges from 1 (Extremely uncomfortable) to 5 (Very comfortable)

    Pre-intervention at Day 1

  • Caregivers' Comfort in Coping With Lack of Appetite for Someone at the End of Life as Assessed by a Likert Scale at Post-Intervention

    Question ranges from 1 (Extremely uncomfortable) to 5 (Very comfortable)

    Post-intervention at Day 1

  • Caregivers' Knowledge in Making Financial Preparations at the End of Life as Assessed by a Likert Scale at Pre-Intervention

    Question ranges from 1 (No knowledge) to 5 (Very knowledgeable)

    Pre-intervention at Day 1

  • Caregivers' Knowledge in Making Financial Preparations at the End of Life as Assessed by a Likert Scale at Post-Intervention

    Question ranges from 1 (No knowledge) to 5 (Very knowledgeable)

    Post-intervention at Day 1

  • Caregivers' Comfort in Managing Agitation and Confusion as Assessed by a Likert Scale at Pre-Intervention

    Question ranges from 1 (Extremely uncomfortable) to 5 (Very comfortable)

    Pre-intervention at Day 1

  • Caregivers' Comfort in Managing Agitation and Confusion as Assessed by a Likert Scale at Post-Intervention

    Question ranges from 1 (Extremely uncomfortable) to 5 (Very comfortable)

    Post-intervention at Day 1

Secondary Outcomes (8)

  • Caregiver Preparedness Scale Score at Pre-Intervention

    Pre-intervention at Day 1

  • Caregiver Preparedness Scale Score at Post-Intervention

    Post-intervention at Day 1

  • Caregiving Competence Scale Score at Pre-Intervention

    Pre-intervention at Day 1

  • Caregiving Competence Scale Score at Post-Intervention

    Post-intervention at Day 1

  • Chronic Pain Self-Efficacy Scale at Pre-Intervention

    Pre-intervention at Day 1

  • +3 more secondary outcomes

Study Arms (2)

African American Hospice Caregivers

EXPERIMENTAL

Culturally tailored educations videos will be administered to African American participants.

Behavioral: Caregiver educational videos for African American caregivers

Puerto Rican Hospice Caregivers

EXPERIMENTAL

Culturally tailored educations videos will be administered to Puerto Rican participants.

Behavioral: Caregiver educational videos for Puerto Rican caregivers

Interventions

Caregiver educational videos for African American caregiversBEHAVIORAL

The intervention will be culturally tailored education videos for African American caregivers receiving hospice services.

African American Hospice Caregivers
Caregiver educational videos for Puerto Rican caregiversBEHAVIORAL

The intervention will be culturally tailored education videos for Puerto Rican caregivers receiving hospice services.

Puerto Rican Hospice Caregivers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Family caregivers who identify themselves as Puerto Rican or African American
  • English and/or Spanish speaking
  • year of age or older
  • Currently receiving home hospice services with a patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

VNS Health

New York, New York, 10017, United States

Location

Hospicio Toque De Amor

Manatí, PR, 00674, Puerto Rico

Location

Hospicio Luz Celeste

Caguas, 00725, Puerto Rico

Location

Results Point of Contact

Title
Dr. Veerawat Phongtankuel
Organization
Weill Cornell Medicine
vep9012@med.cornell.edu
212-746-7000

Study Officials

  • Veerawat Phongtankuel, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2023

First Posted

September 6, 2023

Study Start

June 5, 2023

Primary Completion

February 22, 2024

Study Completion

February 22, 2024

Last Updated

December 11, 2024

Results First Posted

December 11, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)PR(2)