NCT04533594

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 23, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
3 months until next milestone

Results Posted

Study results publicly available

May 25, 2023

Completed
Last Updated

May 25, 2023

Status Verified

May 1, 2023

Enrollment Period

1.5 years

First QC Date

August 28, 2020

Results QC Date

March 9, 2023

Last Update Submit

May 2, 2023

Conditions

Keywords

videoshospice family caregiverseducationtelenovelasself-efficacyanxietyfeasibility

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 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

    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 Outcomes (1)

  • Change in HFCG Satisfaction During and After NOVELA as Assessed by a Single-item Satisfaction Question

    2 weeks and up to 6 weeks

Study Arms (1)

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.

Behavioral: NOVELA

Interventions

NOVELABEHAVIORAL

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.

NOVELA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Univeristy

Baltimore, Maryland, 21287, United States

Location

Related Publications (6)

  • 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: 25594360BACKGROUND
  • 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: 26019262BACKGROUND
  • 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: 31690247BACKGROUND
  • 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: 32638608BACKGROUND
  • Cruz-Oliver DM, Blinka MD, Milner GE, Nelson KE, Bugayong M, Durkin N, Gallo JJ, Oliver DP, Abshire Saylor M. A Mixed-Methods Analysis of Response to NOVELA Among Hospice Family Caregivers. Am J Hosp Palliat Care. 2025 Sep 12:10499091251371149. doi: 10.1177/10499091251371149. Online ahead of print.

  • Cruz-Oliver DM, Abshire Saylor M, Nelson KE, Milner GE, Blinka MD, Durkin N, Budhathoki C, Parker-Oliver D, Smith TJ. Hospice Family Caregiver Perceptions of Benefits and Challenges of a Telenovela Educational Intervention. J Palliat Med. 2022 Jun;25(6):945-951. doi: 10.1089/jpm.2021.0628. Epub 2022 Apr 20.

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

Title
Dulce M. Cruz-Oliver, MD
Organization
JOHNS HOPKINS HOSPITAL

Study Officials

  • DULCE CRUZ-OLIVER, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Single group pretest-posttest design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2020

First Posted

August 31, 2020

Study Start

October 23, 2020

Primary Completion

April 30, 2022

Study Completion

February 28, 2023

Last Updated

May 25, 2023

Results First Posted

May 25, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

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

Shared Documents
CSR
Time Frame
One year after completion or after publication of results and data will be available for an unknown duration of time.
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.
More information

Locations