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

Sponsor
Johns Hopkins University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04533594
Collaborator
University of Colorado, Denver (Other), National Institute of Nursing Research (NINR) (NIH)
60
1
1
25.2
2.4

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: NOVELA
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single group pretest-posttest design.Single group pretest-posttest design.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Improving Self-efficacy Through A Telenovela Intervention for Caregivers of Patients Receiving Hospice Care: Feasibility Study
Actual Study Start Date :
Oct 23, 2020
Actual Primary Completion Date :
Apr 30, 2022
Anticipated Study Completion Date :
Nov 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in HFCG Anxiety before and after NOVELA as assessed by the Generalized Anxiety Disorder 7-item scale [Baseline and 4 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.

  2. Change in HFCG Self-efficacy before and after NOVELA as assessed by the Caregiver Self-Efficacy Scale [Baseline and 4 weeks]

    Caregiver Self-Efficacy Scale (CaSES) - 21-items, scale 1-4, score range 21-84; higher scores reflect higher self-efficacy.

Secondary Outcome Measures

  1. Change in HFCG satisfaction during and after NOVELA as assessed by a single-item satisfaction question [2 and 4 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".

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins Univeristy Baltimore Maryland United States 21287

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT04533594
Other Study ID Numbers:
  • IRB00256812
  • U2CNR014637
First Posted:
Aug 31, 2020
Last Update Posted:
May 20, 2022
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Johns Hopkins University

Study Results

No Results Posted as of May 20, 2022