Developing and Piloting a Multi-component Technology-based Care Intervention to Address Patient Symptoms and Caregiver Burden in Home Hospice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Participant Recruitment Rate
研究概览
简要总结
With the growth of hospice, older adults have the opportunity to receive home-based care aimed at reducing suffering and focusing on quality of life at the end of life. While use of technology and educational videos has yet to be fully developed, structured, and evaluated in home hospice care, it has shown promise to improve care in other settings. Therefore, this study aims to develop and evaluate a multi-component technology-based care intervention, i.e., Improving Home hospice Management of End of life issues through technology (I-HoME).
详细描述
The study intervention focuses on assessing and addressing patient symptoms in the home hospice setting through weekly telehealth visits (for up to 6 weeks) and educational videos that are geared for the patient's informal caregiver. The aim of this phase of the project is two fold. One is that the study team will conduct a single armed (N=6 dyads) pilot study with a focus on optimizing data collection protocols and the intervention. After this step, a randomized pilot study evaluating the feasibility and potential efficacy of I-HoME (N=50 dyads) compared to usual care (N=50 dyads) will be conducted.
Phase I of the study to assess feasibility of the intervention was registered on ClinicalTrials.gov as NCT04074304.
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
- None
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Home hospice caregivers must be:
- •English speaking
- •18 years of age or older
- •not blind
- •having a family member receiving home hospice care
- •Home hospice patients must be:
- •English speaking
- •65 years of age or older
- •not blind
- •enrolled in home hospice care.
排除标准
- •Patients with a terminal diagnosis of dementia or patients who have cognitive impairment and unable to sign a written informed consent will be excluded.
结局指标
主要结局
Participant Recruitment Rate
时间窗: During recruitment (22 months)
Recruitment rate was measured by the number of participants consented divided by the number of eligible participants.
Participant Attrition From Enrollment to End of Study
时间窗: At the end of the intervention or at 6 weeks, which ever is earlier.
This measure is the total number of participants who withdrew consent or were unreachable for study activities after consent.
Percentage of Tele-visits With Hardware Issues Out of the Total Number of Tele-visit Intervention Visits
时间窗: At the end of the intervention or at 6 weeks, which ever is earlier.
After each intervention visit, participants answered questions about whether they experienced technical issues. This measure was calculated by dividing the number of I-HoME tele-visits during which the participant and/or the interventionist experienced hardware issues by the total number of I-HoME tele-visits administered during the entire study period.
Average Length of I-HoME Tele-visit
时间窗: At the end of the intervention or at 6 weeks, which ever is earlier.
This measure was collected by calculating the average duration (in minutes) of each tele-visit between the participant in I-HoME intervention arm and the interventionalist.
Total Number of Educational Videos Watched by I-HoME Intervention Arm Participants
时间窗: At the end of the intervention or at 6 weeks, which ever is earlier.
This measure is the total number of videos watched by the I-HoME intervention arm participants who received at least one tele-visit. Intervention arm participants self-reported whether they watched the educational videos recommended to them by the interventionist.
Number of I-HoME Intervention Caregivers Who Experienced Technical Issues During the Tele-visits.
时间窗: At the end of the intervention or at 6 weeks, which ever is earlier.
The number of I-HoME intervention caregivers who reported at least one technical issues with the tele-visit. Participants in the intervention arm answered questions about whether they experienced technical issues.
Percentage of Tele-visits Conducted Out of the Total Possible Tele-visits.
时间窗: At the end of the intervention or at 6 weeks, which ever is earlier.
This measure is calculated by dividing the tele-visits conducted out of the total possible tele-visits. This measure shows the adherence of the I-HoME intervention arm to the tele-visits.
次要结局
- Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks.(At baseline and weekly for 6 weeks.)
- Number of Patient Hospitalizations From Enrollment to End of Intervention(From enrollment to the end of the intervention or at 6 weeks, which ever is earlier.)