Trial Outcomes & Findings for Improving Self-Efficacy Through a Telenovela: Feasibility Study (NCT NCT04533594)
NCT ID: NCT04533594
Last Updated: 2023-05-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
59 participants
Primary outcome timeframe
Baseline and up to 8 weeks
Results posted on
2023-05-25
Participant Flow
6 participants had their "loved one" died before starting intervention
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.
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.
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|---|---|
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Overall Study
STARTED
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59
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Overall Study
Started Intervention
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53
|
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Overall Study
Completed Final Survey
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44
|
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Overall Study
COMPLETED
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33
|
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Overall Study
NOT COMPLETED
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26
|
Reasons for withdrawal
| 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.
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.
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|---|---|
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Overall Study
Death
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26
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Baseline Characteristics
Improving Self-Efficacy Through a Telenovela: Feasibility Study
Baseline characteristics by cohort
| Measure |
NOVELA
n=59 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.
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.
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|---|---|
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Age, Continuous
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59.8 years
STANDARD_DEVIATION 10.4 • n=5 Participants
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Sex: Female, Male
Female
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47 Participants
n=5 Participants
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Sex: Female, Male
Male
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12 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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59 participants
n=5 Participants
|
|
Education
Primary or secondary school
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16 Participants
n=5 Participants
|
|
Education
College, equivalent and advanced
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42 Participants
n=5 Participants
|
|
Education
Did not report
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1 Participants
n=5 Participants
|
|
Marital Status
Married and/or have a partner
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44 Participants
n=5 Participants
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Marital Status
Divorced and/or separated
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9 Participants
n=5 Participants
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Marital Status
Widowed
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1 Participants
n=5 Participants
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Marital Status
Other (never married or unknown
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5 Participants
n=5 Participants
|
|
Relationship to patient
Child
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29 Participants
n=5 Participants
|
|
Relationship to patient
Parent
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4 Participants
n=5 Participants
|
|
Relationship to patient
Spouse or Life Partner
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15 Participants
n=5 Participants
|
|
Relationship to patient
Other(grandchild, grandparent, friend, sibling, son/daughter-in-law and nephew).
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11 Participants
n=5 Participants
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Hospice diagnosis
Cancer
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19 Participants
n=5 Participants
|
|
Hospice diagnosis
Cardiovascular
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11 Participants
n=5 Participants
|
|
Hospice diagnosis
Neurologic
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14 Participants
n=5 Participants
|
|
Hospice diagnosis
Other (multi-system, infectious and renal. )
|
15 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline and up to 8 weeksPopulation: Only 43 participants had baseline and up to 8 weeks data. The goal was to analyze data for participants who had scores for the baseline and final assessment.
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.
Outcome measures
| Measure |
NOVELA
n=43 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.
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.
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|---|---|
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Change in HFCG Anxiety Before and After NOVELA as Assessed by the Generalized Anxiety Disorder 7-item Scale
Baseline
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8.63 score on a scale
Standard Deviation 5.41
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Change in HFCG Anxiety Before and After NOVELA as Assessed by the Generalized Anxiety Disorder 7-item Scale
Final
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7.67 score on a scale
Standard Deviation 4.77
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PRIMARY outcome
Timeframe: Baseline and up to 8 weeksPopulation: We had 44 participants that completed baseline and up to 8 weeks. The goal was to analyze data for participants who had scores for the baseline and final assessment.
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.
Outcome measures
| Measure |
NOVELA
n=44 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.
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.
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|---|---|
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Change in HFCG Self-efficacy Before and After NOVELA as Assessed by the Caregiver Self-Efficacy Scale
Baseline
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3.01 score on a scale
Standard Deviation 0.47
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Change in HFCG Self-efficacy Before and After NOVELA as Assessed by the Caregiver Self-Efficacy Scale
Final score
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3.05 score on a scale
Standard Deviation 0.40
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SECONDARY outcome
Timeframe: 2 weeks and up to 6 weeksPopulation: We had first and final score of 35 participants. The goal was to analyze data for participants who had scores for the first and final assessment.
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". First score was at 2 weeks and final score was up to 6 weeks from first score assessment.
Outcome measures
| Measure |
NOVELA
n=35 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.
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.
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|---|---|
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Change in HFCG Satisfaction During and After NOVELA as Assessed by a Single-item Satisfaction Question
First score
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4.02 score on a scale
Standard Deviation 1.06
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Change in HFCG Satisfaction During and After NOVELA as Assessed by a Single-item Satisfaction Question
Final score
|
4.26 score on a scale
Standard Deviation 0.89
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Adverse Events
NOVELA
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