A Telenovela Intervention for Caregivers of African-American and Hispanic Hospice Patients

NCT06835764 | Active Not Recruiting

• 2 other identifiers: IRB00457633CRF25
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial (RCT) intends to look at the preliminary efficacy of NOVELA (intervention group) in changing anxiety and self-efficacy compared to usual hospice care (control group). In the NOVELA intervention, hospice care will be enhanced with the telenovela videos for hospice family caregivers (HFCG) education during twice weekly hospice telehealth visits to prepare caregivers for proper use of hospice support and healthcare services.

Conditions

Hospice; Caregivers

Keywords

videos; hospice family caregivers; education; telenovelas; self-efficacy; anxiety; feasibility

Outcome Measures

Primary Outcomes (2)

• 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 participants have been bothered by generalized anxiety. 7-items, scale 0-3, score range 0-21; higher scores reflect higher anxiety.

  Baseline and 2 weeks

• 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 21-84; higher scores reflect higher self-efficacy.

  Baseline and 2 weeks

Study Arms (2)

NOVELA

EXPERIMENTAL

Hospice family caregivers will work with the interventionist to use a web-enabled device (computer, smartphone or tablet) to access and view the video (3-6 mins) over the course of 4 hospice telehealth visits, twice per week.

Behavioral: NOVELA

Usual hospice care

NO INTERVENTION

HFCGs will receive usual hospice care.

Interventions

NOVELA BEHAVIORAL

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) twice per week over the course of 4 hospice telehealth visits (one episode per visit). All four visits will use 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.

NOVELA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• HFCG of patients that are actively dying
• Caregivers younger than 18 years
• With cognitive impairment
• Without internet access.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Maryland Cigarette Restitution Fund: collaborator

Study Sites (1)

Johns Hopkins Univeristy

Baltimore, Maryland, 21287, United States

Location

Related 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.

  PMID: 25594360 BACKGROUND

• 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.

  PMID: 26019262 BACKGROUND

• 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.

  PMID: 31690247 BACKGROUND

• 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.

  PMID: 32638608 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• DULCE CRUZ-OLIVER, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research staff analyzing data will be unaware of study arm assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 19, 2025
• Study Start: December 1, 2024
• Primary Completion: January 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

US (1)