跳至主要内容
临床试验/NCT06835764
NCT06835764已完成不适用

Enhancing Self-Efficacy and Lowering Anxiety Through a Telenovela Intervention for Caregivers of African-American and Hispanic Hospice Patients

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
1
主要终点
HFCG Anxiety Before and After NOVELA as Assessed by the Generalized Anxiety Disorder 7-item Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Research staff analyzing data will be unaware of study arm assignment.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •HFCG of patients that are actively dying
  • •Caregivers younger than 18 years
  • •With cognitive impairment
  • •Without internet access.

研究组 & 干预措施

Usual hospice care

No Intervention

HFCGs will receive usual hospice care.

NOVELA

Experimental

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.

干预措施: NOVELA (Behavioral)

结局指标

主要结局

HFCG Anxiety Before and After NOVELA as Assessed by the Generalized Anxiety Disorder 7-item Scale

时间窗: 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

时间窗: 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)

时间窗: Baseline and 2 weeks

Patient Health Questionnaire (PHQ-8) - Score ranges from 0-24, higher scores reflect higher depressive symptoms.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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