WeCareToFeedDysphagia to Reduce Care-partner Burden Full-scale RCT
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 802
- 试验地点
- 1
- 主要终点
- Mean Care Partner Burden at 3 Months Post Hospital Discharge
研究概览
简要总结
The goal of this clinical trial is to learn if a newly-created website tool, called WeCareToFeedDysphagia, helps to reduce feelings of burden in care partners of patients with Alzheimer's disease and related dementias (AD/ADRD) who were diagnosed with trouble swallowing (oropharyngeal dysphagia). The main questions this study aims to answer are:
- How effective is the WeCareToFeedDysphagia tool in reducing feelings of burden in care partners?
- Does the WeCareToFeed Dysphagia tool help improve patient outcomes?
- Does care partner age, gender, and patient dysphagia severity impact the strength of the effect of the WeCareToFeedDysphagia tool?
- Is the strength of the effect of the WeCareToFeedDysphagia tool impacted by care partner's beliefs in being able to manage behavior and stress (self-efficacy)?
Researchers will compare a group of care partners who have access to the WeCareToFeedDysphagia tool (intervention) to a group of care partners who do not have access to the tool. Both groups will receive contact information for help from a speech language pathologist expert (enhanced usual care).
Participants will:
- be given access to the web tool and receive 3 text message reminders over 3 weeks to use the tool (intervention group only).
- be asked to complete a remote, web-based survey three times: when enrolled in the study, at 1 month following patient leaving the hospital, and at 3 months following patient leaving the hospital.
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
- Double (Investigator, Outcomes Assessor)
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
- •Self-identifies as the primary care partner of an older adult patient (patient age ≥ 65 years) with AD/ADRD and oropharyngeal dysphagia (OD) admitted to the Northwell medicine service
- •Age ≥ 18 years
- •Designated as the legally authorized representative (LAR) or health care proxy (HCP), or designated by the LAR or HCP to participate
- •Proficient in English
- •Has access to a device (e.g. smartphone, iPad, computer) capable of accessing a web browser
排除标准
- •Care partner of patient with a percutaneous feeding tube (i.e. PEG, PEJ used exclusively)
- •Care partner of patient who will not be discharged to the home or community setting (e.g., home, assisted living, independent living)
- •Care partner will not be involved with OD management (e.g. buying or making food, feeding, supervising) after hospital discharge
研究组 & 干预措施
Enhanced Control + WeCareToFeedDysphagia
Participants receive usual care from their medical team and receive contact information for speech-language pathology follow-up care. Participants will also receive access to the WeCareToFeedDysphagia web tool and receive text message reminders to use the tool.
干预措施: WeCareToFeedDysphagia web tool (Behavioral)
Enhanced Control
Participants receive usual care from their medical team and receive contact information for speech-language pathology follow-up care.
结局指标
主要结局
Mean Care Partner Burden at 3 Months Post Hospital Discharge
时间窗: 3 months from hospital discharge
Burden will be measured using the Zarit Burden Scale (ZBI-22), a validated measure that assesses 22 statements related to personal strain accompanying caring for another person, which is rated with 5 frequency-related response categories, scored 0 (never) to 4 (nearly always). The total score ranges between 0 and 88 (higher scores indicating higher burden). A score greater than 21 has been suggested to indicate care-partner burden. Outcome measures will be captured through a link to an online questionnaire which will be sent to the care partner's smart phone/device via text message.
Mean Care Partner Burden at 3 Months Post Hospital Discharge
时间窗: 3 months from hospital discharge
Burden will be measured using the Zarit Burden Scale (ZBI-22), a validated measure that assesses 22 statements related to personal strain accompanying caring for another person, which is rated with 5 frequency-related response categories, scored 0 (never) to 4 (nearly always). The total score ranges between 0 and 88 (higher scores indicating higher burden). A score greater than 21 has been suggested to indicate care-partner burden. Outcome measures will be captured through a link to an online questionnaire which will be sent to the care partner's smart phone/device via text message.
次要结局
- Mean Care Partner Burden at 1 Month Post Hospital Discharge(1 month from hospital discharge)
- Mean Care Partner Quality of Life at 1 Month Post Hospital Discharge(1 month from hospital discharge)
- Mean Care Partner Quality of Life at 3 Months Post Hospital Discharge(3 months from hospital discharge)
- Percent Engagement with the WeCareToFeedDysphagia Tool(3 months from hospital discharge)
- Mean Care Partner Burden at 1 Month Post Hospital Discharge(1 month from hospital discharge)
- Mean Care Partner Quality of Life at 1 Month Post Hospital Discharge(1 month from hospital discharge)
- Mean Care Partner Quality of Life at 3 Months Post Hospital Discharge(3 months from hospital discharge)
- Percent Engagement with the WeCareToFeedDysphagia Tool(3 months from hospital discharge)
研究者
Liron Sinvani
Associate Professor
Northwell Health