Trial Outcomes & Findings for A Telenovela Intervention for Caregivers of African-American and Hispanic Hospice Patients (NCT NCT06835764)
NCT ID: NCT06835764
Last Updated: 2026-06-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
Baseline and 2 weeks
Results posted on
2026-06-30
Participant Flow
Participant milestones
| Measure |
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, twice per week.
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) 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.
|
Usual Hospice Care
HFCGs will receive usual hospice care.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
28
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
18
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Telenovela Intervention for Caregivers of African-American and Hispanic Hospice Patients
Baseline characteristics by cohort
| Measure |
NOVELA
n=34 Participants
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.
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) 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.
|
Usual Hospice Care
n=28 Participants
HFCGs will receive usual hospice care.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 16.2 • n=20 Participants
|
59.6 years
STANDARD_DEVIATION 13.8 • n=20 Participants
|
59.3 years
STANDARD_DEVIATION 15.1 • n=40 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=20 Participants
|
26 Participants
n=20 Participants
|
53 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=20 Participants
|
19 Participants
n=20 Participants
|
43 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
24 Participants
n=20 Participants
|
19 Participants
n=20 Participants
|
43 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
34 Participants
n=20 Participants
|
28 Participants
n=20 Participants
|
62 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline and 2 weeksPopulation: Participants with data collected.
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.
Outcome measures
| Measure |
NOVELA
n=28 Participants
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.
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) 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.
|
Usual Hospice Care
n=24 Participants
HFCGs will receive usual hospice care.
|
|---|---|---|
|
HFCG Anxiety Before and After NOVELA as Assessed by the Generalized Anxiety Disorder 7-item Scale
Baseline
|
5.39 units on a scale
Standard Deviation 4.72
|
7.58 units on a scale
Standard Deviation 5.72
|
|
HFCG Anxiety Before and After NOVELA as Assessed by the Generalized Anxiety Disorder 7-item Scale
2 weeks
|
5.25 units on a scale
Standard Deviation 4.14
|
8.20 units on a scale
Standard Deviation 4.71
|
PRIMARY outcome
Timeframe: Baseline and 2 weeksPopulation: Participants with data collected
Caregiver Self-Efficacy Scale (CaSES) - 21-items, scale range 1-4,; higher scores reflect higher self-efficacy. Mean participant's scale choice is reported.
Outcome measures
| Measure |
NOVELA
n=28 Participants
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.
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) 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.
|
Usual Hospice Care
n=24 Participants
HFCGs will receive usual hospice care.
|
|---|---|---|
|
HFCG Self-efficacy Before and After NOVELA as Assessed by the Caregiver Self-Efficacy Scale
Baseline
|
3.13 units on a scale
Standard Deviation 0.42
|
3.12 units on a scale
Standard Deviation 0.38
|
|
HFCG Self-efficacy Before and After NOVELA as Assessed by the Caregiver Self-Efficacy Scale
2 weeks
|
3.17 units on a scale
Standard Deviation 0.47
|
2.95 units on a scale
Standard Deviation 0.40
|
PRIMARY outcome
Timeframe: Baseline and 2 weeksPopulation: Participants with data collected.
Patient Health Questionnaire (PHQ-8) - Score ranges from 0-24, higher scores reflect higher depressive symptoms.
Outcome measures
| Measure |
NOVELA
n=28 Participants
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.
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) 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.
|
Usual Hospice Care
n=24 Participants
HFCGs will receive usual hospice care.
|
|---|---|---|
|
HFCG Depression Before and After NOVELA as Assessed by the Patient Health Questionnaire 8-item Scale (PHQ-8)
Baseline
|
4.39 units on a scale
Standard Deviation 4.56
|
5.96 units on a scale
Standard Deviation 5.13
|
|
HFCG Depression Before and After NOVELA as Assessed by the Patient Health Questionnaire 8-item Scale (PHQ-8)
2 weeks
|
4.31 units on a scale
Standard Deviation 3.55
|
7.40 units on a scale
Standard Deviation 3.50
|
Adverse Events
NOVELA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Hospice Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place