An interventional study of NOVELA in Hospice and Caregivers, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Supportive care
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.
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:
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 62 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
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Exclusion Criteria:
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
HFCGs will receive usual hospice care.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 2 weeks
| Milestone | NOVELA | Usual Hospice Care |
|---|---|---|
| Started | 34 | 28 |
| Completed | 16 | 16 |
| Not completed | 18 | 12 |
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.
| units on a scale | NOVELA | Usual Hospice Care |
|---|---|---|
| Baseline | 5.39 ± 4.72 | 7.58 ± 5.72 |
| 2 weeks | 5.25 ± 4.14 | 8.20 ± 4.71 |
Caregiver Self-Efficacy Scale (CaSES) - 21-items, scale range 1-4,; higher scores reflect higher self-efficacy. Mean participant's scale choice is reported.
| units on a scale | NOVELA | Usual Hospice Care |
|---|---|---|
| Baseline | 3.13 ± 0.42 | 3.12 ± 0.38 |
| 2 weeks | 3.17 ± 0.47 | 2.95 ± 0.40 |
Patient Health Questionnaire (PHQ-8) - Score ranges from 0-24, higher scores reflect higher depressive symptoms.
| units on a scale | NOVELA | Usual Hospice Care |
|---|---|---|
| Baseline | 4.39 ± 4.56 | 5.96 ± 5.13 |
| 2 weeks | 4.31 ± 3.55 | 7.40 ± 3.50 |
Collected over From baseline up to 4 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NOVELA | 0/34 (0%) | 0/34 (0%) | 0/34 (0%) |
| Usual Hospice Care | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
Participants with data collected.
| Age, Continuous(years) | NOVELA | Usual Hospice Care | Total |
|---|---|---|---|
| Mean | 59.1 ± 16.2 | 59.6 ± 13.8 | 59.3 ± 15.1 |
| Sex: Female, Male(Participants) | NOVELA | Usual Hospice Care | Total |
|---|---|---|---|
| Female | 27 | 26 | 53 |
| Male | 7 | 2 | 9 |
| Ethnicity (NIH/OMB)(Participants) | NOVELA | Usual Hospice Care | Total |
|---|---|---|---|
| Hispanic or Latino | 24 | 19 | 43 |
| Not Hispanic or Latino | 10 | 9 | 19 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | NOVELA | Usual Hospice Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 10 | 9 | 19 |
| White | 0 | 0 | 0 |
| More than one race | 24 | 19 | 43 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | NOVELA | Usual Hospice Care | Total |
|---|---|---|---|
| United States | 34 | 28 | 62 |
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