Improving Self-Efficacy Through a Telenovela: Feasibility Study (NOVELA)

May 2, 2023 updated by: Johns Hopkins University

Improving Self-efficacy Through A Telenovela Intervention for Caregivers of Patients Receiving Hospice Care: Feasibility Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Univeristy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NOVELA
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HFCG Anxiety Before and After NOVELA as Assessed by the Generalized Anxiety Disorder 7-item Scale
Time Frame: Baseline and up to 8 weeks

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
Change in HFCG Self-efficacy Before and After NOVELA as Assessed by the Caregiver Self-Efficacy Scale
Time Frame: Baseline and up to 8 weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HFCG Satisfaction During and After NOVELA as Assessed by a Single-item Satisfaction Question
Time Frame: 2 weeks and up to 6 weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

University of Colorado, Denver
National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: DULCE CRUZ-OLIVER, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2020

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

August 28, 2020

First Submitted That Met QC Criteria

August 28, 2020

First Posted (Actual)

August 31, 2020

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00256812
  • U2CNR014637 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The de-identified data will be submitted to the Palliative Care Research Cooperative (PCRC) data repository at the end of pilot study.

IPD Sharing Time Frame

One year after completion or after publication of results and data will be available for an unknown duration of time.

IPD Sharing Access Criteria

Investigators may request access to the de-identified PCRC Data Repositories for secondary data analysis. Each request must be submitted in writing, must identify the research question that will be addressed, and must specify the data elements that are requested. Each request must also include a data security plan and explanation of how and for how long the data will be stored and who will have access to the data. The PCRC, and when applicable the Study Principal Investigator (PI), reviews all data requests. If all requirements are adequately met, arrangements are made to transfer the data in the most efficient, secure,and affordable manner to the requesting investigator.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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