Caregivers, Hospice
Conditions
Keywords
videos, hospice family caregivers, education, telenovelas, self-efficacy, anxiety, feasibility
Brief 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). 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.
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) 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.
Sponsors
Johns Hopkins University
Maryland Cigarette Restitution Fund
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Research staff analyzing data will be unaware of study arm assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 |
|---|---|---|
| HFCG Anxiety Before and After NOVELA as Assessed by the Generalized Anxiety Disorder 7-item Scale | 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 | 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) | Baseline and 2 weeks | Patient Health Questionnaire (PHQ-8) - Score ranges from 0-24, higher scores reflect higher depressive symptoms. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDULCE CRUZ-OLIVER, MD
Johns Hopkins University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 59.6 years STANDARD_DEVIATION 13.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 43 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 19 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 62 Participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 28 |
| other Total, other adverse events | 0 / 34 | 0 / 28 |
| serious Total, serious adverse events | 0 / 34 | 0 / 28 |
Outcome results
None listed