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Caregivers of Patients on Hospice CareNCT06024278

Developing and Testing Culturally Based Educational Videos for Puerto Rican and African American Home Hospice Caregivers

A study testing Caregiver educational videos for African American caregivers and Caregiver educational videos for Puerto Rican caregivers in people with Caregivers of Patients on Hospice Care, run by Weill Medical College of Cornell University at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Caregivers of Patients on Hospice Care
What is being tested?
Caregiver educational videos for African American caregivers and Caregiver educational videos for Puerto Rican caregivers
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
3 sitesin 2 countries
Study dates
5 Jun 2023to 22 Feb 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

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

Who cannot join

None listed.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Puerto Rico2 sites
  • Hospicio Luz Celeste

    Caguas, 00725

  • Hospicio Toque De Amor

    Manati, PR, 00674

Other trials in Puerto Rico

United States1 site
  • VNS Health

    New York, New York, 10017

Other trials in United States

About this study

Official title: Developing and Pilot Testing Culturally Based Educational Videos for Puerto Rican and African American Home Hospice Caregivers

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.

Read the detailed description

The clinical trial for this project is a cross-sectional study conducted with VNS Health hospice, Hospicio Toque de Amor, and Hospicio Luz Celeste. Names of Puerto Rican and African American caregivers receiving home hospice care will be referred to the study team by the site leader/hospice leadership at each hospice. Demographic data will be collected from each caregiver participant. Prior to showing participants the culturally tailored videos, a research member will administer a set of Likert style questions developed by the research team around comfort in managing symptom related issues. The same questions will be administered again post video intervention. In addition, the preparedness scale, chronic pain self-efficacy scale, and caregiving competence scale will be administered to participants pre and post video intervention. The PI will not be involved in the administering the intervention for this study. After the culturally tailored videos have been shown to the participant, a research member will also conduct an open-ended interview about content, reactions, attitudes, usefulness and limitations around each video. Interviews will be conducted in either English and/or Spanish.

Being tested
Caregiver educational videos for African American caregivers, Caregiver educational videos for Puerto Rican caregivers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Caregiver educational videos for African American caregiversBehavioural

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

  • Caregiver educational videos for Puerto Rican caregiversBehavioural

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

Study groups in NCT06024278
Study groupRoleWhat they receive
African American Hospice CaregiversExperimentalCulturally tailored educations videos will be administered to African American participants.
Receives: Behavioral: Caregiver educational videos for African American caregivers
Puerto Rican Hospice CaregiversExperimentalCulturally tailored educations videos will be administered to Puerto Rican participants.
Receives: Behavioral: Caregiver educational videos for Puerto Rican caregivers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Pre-intervention at Day 1

  2. 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)

    Measured: Post-intervention at Day 1

  3. 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)

    Measured: Pre-intervention at Day 1

  4. 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)

    Measured: Post-intervention at Day 1

  5. 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)

    Measured: Pre-intervention at Day 1

  6. 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)

    Measured: Post-intervention at Day 1

  7. 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)

    Measured: Pre-intervention at Day 1

  8. 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)

    Measured: Post-intervention at Day 1

  9. 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)

    Measured: Pre-intervention at Day 1

  10. 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)

    Measured: Post-intervention at Day 1

  11. 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)

    Measured: Pre-intervention at Day 1

  12. 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)

    Measured: Post-intervention at Day 1

  13. 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)

    Measured: Pre-intervention at Day 1

  14. 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)

    Measured: Post-intervention at Day 1

  15. 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)

    Measured: Pre-intervention at Day 1

  16. 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)

    Measured: Post-intervention at Day 1

  17. 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)

    Measured: Pre-intervention at Day 1

  18. 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)

    Measured: Post-intervention at Day 1

  19. 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)

    Measured: Pre-intervention at Day 1

  20. 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)

    Measured: Post-intervention at Day 1

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

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

    Measured: Pre-intervention at Day 1

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

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

    Measured: Post-intervention at Day 1

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

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

    Measured: Pre-intervention at Day 1

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

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

    Measured: Post-intervention at Day 1

  25. 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)

    Measured: Pre-intervention at Day 1

  26. 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)

    Measured: Post-intervention at Day 1

  27. 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)

    Measured: Pre-intervention at Day 1

  28. 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)

    Measured: Post-intervention at Day 1

  29. 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)

    Measured: Pre-intervention at Day 1

  30. 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)

    Measured: Post-intervention at Day 1

  31. 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)

    Measured: Pre-intervention at Day 1

  32. 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)

    Measured: Post-intervention at Day 1

Secondary outcomes (8)
  1. Caregiver Preparedness Scale Score at Pre-Intervention

    An 8-item scale. Each question ranges from 0 (Not at all prepared) to 4 (Very well prepared). Total score can range from 0 to 32 with higher scores are indicative of feeling better prepared for the caregiving role.

    Measured: Pre-intervention at Day 1

  2. Caregiver Preparedness Scale Score at Post-Intervention

    An 8-item scale. Each question ranges from 0 (Not at all prepared) to 4 (Very well prepared). Total score can range from 0 to 32 with higher scores are indicative of feeling better prepared for the caregiving role.

    Measured: Post-intervention at Day 1

  3. Caregiving Competence Scale Score at Pre-Intervention

    A 4-item scale. Each question ranges from 1 (Not at all competent) to 4 (Very competent)

    Measured: Pre-intervention at Day 1

  4. Caregiving Competence Scale Score at Post-Intervention

    A 4-item scale. Each question ranges from 1 (Not at all competent) to 4 (Very competent)

    Measured: Post-intervention at Day 1

  5. Chronic Pain Self-Efficacy Scale at Pre-Intervention

    A 22-item scale. Each question is rated on a Likert scale between 10 (very uncertain) to 100 (very certain).

    Measured: Pre-intervention at Day 1

  6. Chronic Pain Self-Efficacy Scale at Post-Intervention

    A 22-item scale. Each question is rated on a Likert scale between 10 (very uncertain) to 100 (very certain).

    Measured: Post-intervention at Day 1

  7. Number of Participants Who Provided Qualitative Feedback That Each Video Culturally Tailored for African American Hospice Caregivers Was Helpful at Post-Intervention

    Open ended interviews will be conducted to obtain participant feedback around content, attitudes, usefulness and limitations of the videos. Participants will answer questions asking if each video was helpful in improving their knowledge and comfort with managing their care recipient's symptoms.

    Video 1 includes content on managing shortness of breath, delivering liquid medication to a patient, and caregiver resources offered in hospice care. Video 2 includes content on using opioids to treat pain and turning a patient in bed. Video 3 includes content on recognizing agitation and confusion in a patient. Video 4 includes content on recognizing the signs and symptoms when a patient is at the end of life.

    Measured: Post-intervention at Day 1

  8. Number of Participants Who Provided Qualitative Feedback That Each Video Culturally Tailored for Puerto Rican Hospice Caregivers Was Helpful at Post-Intervention

    Open ended interviews will be conducted to obtain participant feedback around content, attitudes, usefulness and limitations of the videos. Participants will answer questions asking if each video was helpful in improving their knowledge and comfort with managing their care recipient's symptoms.

    Video 1 includes content on managing shortness of breath related to anxiety, using opioids to ease shortness of breath, and spiritual resources offered in hospice care. Video 2 includes content on managing nausea, managing constipation, and recognizing caregiver stress. Video 3 includes content on coping with lack of appetite for someone at the end of life. Video 4 includes content on making financial preparations at the end of life, managing agitation and confusion, and recognizing end-of-life signs and symptoms.

    Measured: Post-intervention at Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2023
  2. Study start5 Jun 2023
  3. Primary completion22 Feb 2024
  4. Study completion22 Feb 2024

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06024278
Sponsor's protocol ID
22-04024661
Other IDs
3K76AG059997-03S1
Status last verified
Nov 2024
First submitted
29 Aug 2023
Last updated
11 Dec 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Caregiver educational videos for African American caregivers and Caregiver educational videos for Puerto Rican caregivers in people with Caregivers of Patients on Hospice Care, run by Weill Medical College of Cornell University at 3 sites in 2 countries.

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 4 inclusion and 0 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: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Puerto Rico, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 11 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Caregivers' Comfort in Managing Shortness of Breath as Assessed by a Likert Scale at Pre-Intervention (time frame: Pre-intervention at Day 1). The study lists 32 primary outcomes in all. 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 11 Dec 2024.

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