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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04533594
Other study ID # IRB00256812
Secondary ID U2CNR014637
Status Completed
Phase N/A
First received
Last updated
Start date October 23, 2020
Est. completion date February 28, 2023

Study information

Verified date May 2023
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In the NOVELA intervention, hospice care will be enhanced with the telenovela videos for hospice family caregivers (HFCG) education during weekly hospice visits to prepare caregivers for proper use of hospice support and healthcare services


Description:

Telenovela is a television drama or soap opera that can be used to lead viewers to contemplate and discuss critical issues through video storytelling. Prior work showed informational telenovelas had a positive effect on Latino family caregivers' attitudes toward end-of-life (EOL) care services. The role of videos in hospice and palliative care shows significant promise, underscoring the videos as a mode of education for family caregivers that could potentially enhance caregiver's self-efficacy, decrease caregiver's anxiety, and reduce burnout. Despite the value of video education, many programs have failed to provide engaging material. Based on input from HFCG, the investigators have produced a bilingual (Spanish and English version) four chapter telenovela video series (To Care/ El privilegio de cuidar) as part of NCI funded diversity supplement study. Founded upon extensive preliminary work, To Care portrays the journey of one hospice family as the family struggle with the hospice decision, pain management, decision-making, and finally the dying process. Averaging only 4:65 minutes, each chapter addresses one of these problems, validating family experiences and identifying potential solutions. Based on this work and interviews with hospice staff the investigators have built an intervention, NOVELA, to disseminate telenovelas to family caregivers in hospice agencies. The investigators will test the feasibility of NOVELA delivery in the hospice setting and evaluate efficacy of the intervention. The overall expectation is that NOVELA will improve self-efficacy thus lowering anxiety in hospice family caregivers. This proposal has the following aims: - Specific Aim 1: To pilot test the feasibility and acceptability of integrating NOVELA with hospice care for family caregivers of hospice patients - Specific Aim 2: To investigate the preliminary efficacy of integrating NOVELA with hospice care for family caregivers of hospice patients


Recruitment information / eligibility

Status Completed
Enrollment 59
Est. completion date February 28, 2023
Est. primary completion date April 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Identified family caregiver of patients enrolled in hospice - Caregivers must be over the age of 18 - Without cognitive impairment - With access to wireless device and internet. Exclusion Criteria: - HFCG of patients that are actively dying - Caregivers younger than 18 years - With cognitive impairment - Without internet access.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
NOVELA
The family caregivers that consent to participate will work with the interventionist to use a web-enabled device (computer, smartphone or tablet) to access and view the telenovela video (one of four episodes, each 3-6 mins) over the course of 4 hospice visits (one episode per visit). All four visits will be in person using telehealth via video-conferencing. The number of visits is based on the number of videos which content is prioritized based on previous work. The interventionist will introduce the purpose and topic of the video, facilitate video viewing and then elicit clarifying questions and reinforce main message.

Locations

Country Name City State
United States Johns Hopkins Univeristy Baltimore Maryland

Sponsors (3)

Lead Sponsor Collaborator
Johns Hopkins University National Institute of Nursing Research (NINR), University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (4)

Crist JD, Pasvogel A, Hepworth JT, Koerner KM. The impact of a telenovela intervention on use of home health care services and Mexican American older adult and caregiver outcomes. Res Gerontol Nurs. 2015 Mar-Apr;8(2):62-76. doi: 10.3928/19404921-20150105-02. Epub 2015 Jan 16. — View Citation

Cruz-Oliver DM, Abshire M, Budhathoki C, Oliver DP, Volandes A, Smith TJ. Reflections of Hospice Staff Members About Educating Hospice Family Caregivers Through Telenovela. Am J Hosp Palliat Care. 2021 Feb;38(2):161-168. doi: 10.1177/1049909120936169. Epub 2020 Jul 8. — View Citation

Cruz-Oliver DM, Malmstrom TK, Fernandez N, Parikh M, Garcia J, Sanchez-Reilly S. Education Intervention "Caregivers Like Me" for Latino Family Caregivers Improved Attitudes Toward Professional Assistance at End-of-life Care. Am J Hosp Palliat Care. 2016 Jul;33(6):527-36. doi: 10.1177/1049909115584315. Epub 2015 May 27. — View Citation

Washington KT, Oliver DP, Benson JJ, Rolbiecki AJ, Jorgensen LA, Cruz-Oliver DM, Demiris G. Factors influencing engagement in an online support group for family caregivers of individuals with advanced cancer. J Psychosoc Oncol. 2020 May-Jun;38(3):235-250. doi: 10.1080/07347332.2019.1680592. Epub 2019 Nov 6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in HFCG Anxiety Before and After NOVELA as Assessed by the Generalized Anxiety Disorder 7-item Scale Generalized Anxiety Disorder 7-item (GAD-7) scale. Family caregiver indicate the frequency they have been bothered by generalized anxiety. 7-items, scale 0-3, score range 0-21; higher scores reflect higher anxiety.
Final score was collected up to 8 weeks from baseline.
Baseline and up to 8 weeks
Primary Change in HFCG Self-efficacy Before and After NOVELA as Assessed by the Caregiver Self-Efficacy Scale Caregiver Self-Efficacy Scale (CaSES) - 21-items, scale 1-4, score range 1-4; higher scores reflect higher self-efficacy.
Final score was collected up to 8 weeks from baseline.
Baseline and up to 8 weeks
Secondary Change in HFCG Satisfaction During and After NOVELA as Assessed by a Single-item Satisfaction Question Single-item satisfaction question related to HFCG satisfaction with intervention. Investigator developed Likert scale item scored from 1 to 5 where 1 = "Not satisfied" and 5 = "Very satisfied".
First score was at 2 weeks and final score was up to 6 weeks from first score assessment.
2 weeks and up to 6 weeks
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