HospiceNOVELANCT06835764
A Telenovela Intervention for Caregivers of African-American and Hispanic Hospice Patients
A study testing NOVELA in people with Hospice and Caregivers, run by Johns Hopkins University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospice, Caregivers
- What is being tested?
- NOVELA
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- HFCG of patients that are actively dying
- Caregivers younger than 18 years
- With cognitive impairment
- Without internet access.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Self-Efficacy and Lowering Anxiety Through a Telenovela Intervention for Caregivers of African-American and Hispanic Hospice Patients
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.
Read the 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.
In a follow-up study, the investigators developed an interventionist-led conversation guide as a companion for the telenovela. The intervention, which includes the video series and the conversation guide, is named NOVELA (short for telenovela). The investigators preliminary single-arm trial found NOVELA feasible and acceptable in the hospice setting, with promising improvements in caregiver anxiety symptoms. Thus, storytelling and culturally tailored videos can be powerful tools to educate family caregivers of hospice patients. 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: Investigate the preliminary efficacy of delivering NOVELA to African American (AA) and Hispanic HFCGs of cancer patients.
- Specific Aim 2: Evaluate the benefits of NOVELA as perceived by hospice staff.
- Conditions
- Hospice, Caregivers
- Being tested
- NOVELA
- Keywords
- videos, hospice family caregivers, education, telenovelas, self-efficacy, anxiety, feasibility
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOVELABehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: NOVELA |
| Usual hospice care | No intervention | HFCGs will receive usual hospice care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. Score range 0-21; higher scores reflect higher anxiety.
Measured: Baseline and 2 weeks
HFCG Self-efficacy Before and After NOVELA as Assessed by the Caregiver Self-Efficacy Scale
Caregiver Self-Efficacy Scale (CaSES) - 21-items, scale range 1-4,; higher scores reflect higher self-efficacy. Mean participant's scale choice is reported.
Measured: Baseline and 2 weeks
HFCG Depression Before and After NOVELA as Assessed by the Patient Health Questionnaire 8-item Scale (PHQ-8)
Patient Health Questionnaire (PHQ-8) - Score ranges from 0-24, higher scores reflect higher depressive symptoms.
Measured: Baseline and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start1 Dec 2024
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HospiceStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Maryland Cigarette Restitution Fund
- Responsible party
- Sponsor
- Investigators
- DULCE CRUZ-OLIVER, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835764
- Sponsor's protocol ID
- IRB00457633
- Other IDs
- CRF25
- Acronym
- NOVELA
- Status last verified
- Jun 2026
- First submitted
- 14 Feb 2025
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25594360Cruz-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.
PubMed 26019262Washington 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.
PubMed 31690247Cruz-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.
PubMed 32638608
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Self-Efficacy and Lowering Anxiety Through a Telenovela Intervention for Caregivers of African-American and Hispanic Hospice Patients
- ClinicalTrials.gov ID
- NCT06835764
- Acronym / sponsor ID
- NOVELA / IRB00457633
- Conditions
- Hospice, Caregivers
- Keywords
- videos, hospice family caregivers, education, telenovelas, self-efficacy, anxiety, feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Maryland Cigarette Restitution Fund
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 19 Feb 2025 (actual)
- Results
- Posted 30 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
In a follow-up study, the investigators developed an interventionist-led conversation guide as a companion for the telenovela. The intervention, which includes the video series and the conversation guide, is named NOVELA (short for telenovela). The investigators preliminary single-arm trial found NOVELA feasible and acceptable in the hospice setting, with promising improvements in caregiver anxiety symptoms. Thus, storytelling and culturally tailored videos can be powerful tools to educate family caregivers of hospice patients. 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: Investigate the preliminary efficacy of delivering NOVELA to African American (AA) and Hispanic HFCGs of cancer patients.
- Specific Aim 2: Evaluate the benefits of NOVELA as perceived by hospice staff.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NOVELA | Experimental | Behavioral: NOVELAHospice 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. |
| Usual hospice care | No intervention | –HFCGs will receive usual hospice care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- HFCG of patients that are actively dying
- Caregivers younger than 18 years
- With cognitive impairment
- Without internet access.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOVELAThe 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. | Behavioural | NOVELA |
Primary outcome
HFCG Anxiety Before and After NOVELA as Assessed by the Generalized Anxiety Disorder 7-item Scale
Time frame: Baseline and 2 weeks
Generalized Anxiety Disorder 7-item (GAD-7) scale. Family caregiver indicate the frequency participants have been bothered by generalized anxiety. Score range 0-21; higher scores reflect higher anxiety.
HFCG Self-efficacy Before and After NOVELA as Assessed by the Caregiver Self-Efficacy Scale
Time frame: Baseline and 2 weeks
Caregiver Self-Efficacy Scale (CaSES) - 21-items, scale range 1-4,; higher scores reflect higher self-efficacy. Mean participant's scale choice is reported.
HFCG Depression Before and After NOVELA as Assessed by the Patient Health Questionnaire 8-item Scale (PHQ-8)
Time frame: Baseline and 2 weeks
Patient Health Questionnaire (PHQ-8) - Score ranges from 0-24, higher scores reflect higher depressive symptoms.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25594360Crist 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.
- Background: PubMed 26019262Cruz-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.
- Background: PubMed 31690247Washington 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.
- Background: PubMed 32638608Cruz-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DULCE CRUZ-OLIVER, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOVELA in people with Hospice and Caregivers, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HFCG Anxiety Before and After NOVELA as Assessed by the Generalized Anxiety Disorder 7-item Scale (time frame: Baseline and 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06835764, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.