Healthy
Conditions
Keywords
videos, hospice family caregivers, education, telenovelas, self-efficacy, anxiety, feasibility
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
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. Based on this work and interviews with hospice staff the investigators have built an intervention, NOVELA, to disseminate telenovelas to family caregivers in hospice agencies. The investigators will test the feasibility of NOVELA delivery in the hospice setting and evaluate efficacy of the intervention. 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: To pilot test the feasibility and acceptability of integrating NOVELA with hospice care for family caregivers of hospice patients * Specific Aim 2: To investigate the preliminary efficacy of integrating NOVELA with hospice care for family caregivers of hospice patients
Interventions
BEHAVIORALNOVELA
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.
Sponsors
Johns Hopkins University
University of Colorado, Denver
National Institute of Nursing Research (NINR)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Single group pretest-posttest design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* HFCG of patients that are actively dying * Caregivers younger than 18 years * With cognitive impairment * Without internet access.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HFCG Anxiety Before and After NOVELA as Assessed by the Generalized Anxiety Disorder 7-item Scale | Baseline and up to 8 weeks | 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. |
| Change in HFCG Self-efficacy Before and After NOVELA as Assessed by the Caregiver Self-Efficacy Scale | Baseline and up to 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HFCG Satisfaction During and After NOVELA as Assessed by a Single-item Satisfaction Question | 2 weeks and up to 6 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDULCE CRUZ-OLIVER, MD
Johns Hopkins University
Participant flow
Pre-assignment details
6 participants had their "loved one" died before starting intervention
Participants by arm
| Arm | Count |
|---|---|
| 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. | 59 |
| Total | 59 |
Baseline characteristics
| Characteristic | NOVELA |
|---|---|
| Age, Continuous | 59.8 years STANDARD_DEVIATION 10.4 |
| Education College, equivalent and advanced | 42 Participants |
| Education Did not report | 1 Participants |
| Education Primary or secondary school | 16 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Hospice diagnosis Cancer | 19 Participants |
| Hospice diagnosis Cardiovascular | 11 Participants |
| Hospice diagnosis Neurologic | 14 Participants |
| Hospice diagnosis Other (multi-system, infectious and renal. ) | 15 Participants |
| Marital Status Divorced and/or separated | 9 Participants |
| Marital Status Married and/or have a partner | 44 Participants |
| Marital Status Other (never married or unknown | 5 Participants |
| Marital Status Widowed | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Region of Enrollment United States | 59 participants |
| Relationship to patient Child | 29 Participants |
| Relationship to patient Other(grandchild, grandparent, friend, sibling, son/daughter-in-law and nephew). | 11 Participants |
| Relationship to patient Parent | 4 Participants |
| Relationship to patient Spouse or Life Partner | 15 Participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: Baseline and up to 8 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOVELA | Change in HFCG Anxiety Before and After NOVELA as Assessed by the Generalized Anxiety Disorder 7-item Scale | Baseline | 8.63 score on a scale | Standard Deviation 5.41 |
| NOVELA | Change in HFCG Anxiety Before and After NOVELA as Assessed by the Generalized Anxiety Disorder 7-item Scale | Final | 7.67 score on a scale | Standard Deviation 4.77 |
Primary
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.
Time frame: Baseline and up to 8 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOVELA | Change in HFCG Self-efficacy Before and After NOVELA as Assessed by the Caregiver Self-Efficacy Scale | Baseline | 3.01 score on a scale | Standard Deviation 0.47 |
| NOVELA | Change in HFCG Self-efficacy Before and After NOVELA as Assessed by the Caregiver Self-Efficacy Scale | Final score | 3.05 score on a scale | Standard Deviation 0.4 |
Secondary
Change in HFCG Satisfaction During and After NOVELA as Assessed by a Single-item Satisfaction Question
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.
Time frame: 2 weeks and up to 6 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NOVELA | 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 |
| NOVELA | Change in HFCG Satisfaction During and After NOVELA as Assessed by a Single-item Satisfaction Question | First score | 4.02 score on a scale | Standard Deviation 1.06 |