Digital Solutions for Elderly Care by Informal Caregivers: A Study on Nursing Benefits
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Mean change in function and disability of the elderly participant estimated with Barthel Index (BI)
研究概览
简要总结
The study aims to determine the benefits of a web-based documentation and advice for elderly people and their caregivers. It is a randomized controlled trial with two arms (intervention, control). While the participants will be supported by a web-based application within the intervention, they will receive standard care only in the control. In addition, a follow-up until the end of the study will be realized.
详细描述
Background: The majority of elderly people want to live at home, and the home care they need is often provided by informal caregivers. In addition, the number of elderly people is increasing while the number of people who can support them is decreasing. It is therefore important to improve the quality of care and support caregivers. Unfortunately, caregivers are often under heavy strain and the amount of time they can spend receiving advice and support is very limited. Web-based applications could be a solution to address the time needs of caregivers, but little is known about whether such applications are of benefit to the elderly themselves or their caregivers.
Description of the Intervention: A web-based documentation and advice application for home care for elderly people. The intervention is based on the daily status diary, the completion of daily tasks, the writing of short reports (if applicable) and the documentation of the caregiver's constitution. Adherence to the purpose of the web-based application is defined as entering data at least 5 out of 7 days per week.
It is a single-center, open-label, randomized controlled trial with two arms (intervention, control). The study consists of one in person screening visit, two in person study visits and 3 monthly follow-up visits via phone (Visit 0: Screening Visit, Visit 1: Baseline Visit, Visit 2: End of Study Visit, Visit 3: Follow-up). The study-related measurements are: Barthel Index, Short Form of the Late Life Function and Disability Instrument, 5-level EuroQol quality of life questionnaire (EQ-5D-5L), De Morton Mobility Index (DEMMI), individual's general self-efficacy (GSE), user experience questionnaire short form (UEQ-S), Adherence (minimum frequency with which the daily diary was completed by the caregiver). The study begins when both parties in the pair (elderly person and caregiver) sign the informed consent form and ends when the older person dies or the study ends, whichever comes first. The intervention period is 12 weeks.
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
Only pseudonymous, blinded data will be provided to statisticians for analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for the Elderly Person:
- •55 years and older
- •Community-dwelling
- •Resident in Upper Austria
- •Barthel Index below 100
- •Requires assistance with activities of daily living
排除标准
- •for the Elderly Person:
- •Planned nursing home admission in the next 12 weeks
- •Chronic obstructive pulmonary disease stage III or IV
- •Insufficient understanding and judgment to consent to the study
- •Main Inclusion Criteria for the Caregiver:
- •Caregiver of an older person
- •Tech savvy
- •Committed to using an app to support caregiving
- •Main Exclusion Criteria for the Caregiver:
- •17 years and younger
- •Insufficient insight and judgment to consent to the study
结局指标
主要结局
Mean change in function and disability of the elderly participant estimated with Barthel Index (BI)
时间窗: 104 Weeks
The BI assesses the functional status and independence in basic activities of daily living (ADL) of elderly people. Each domain is scored on a 0-5 or 0-10 scale, with the overall score ranging from 0 to 100. A higher score represents a higher level of independence. The BI will be rated by the study staff. The Hamburg Classification Manual provides detailed criteria for scoring.
次要结局
- Mean change in function and disability of the elderly participant estimated with Short Form of the Late-Life Function and Disability Instrument (SF-LLFDI)(104 Weeks)
- Mean change in quality of life of the elderly participant estimated using the 5-item and 5-dimension versions of the EuroQoL questionnaire (EQ-5D-5L)(104 Weeks)
- Mean change in mobility of the elderly participant estimated with the de Morton Mobility Index (DEMMI)(104 Weeks)
- Mean change in self-efficacy of the elderly participant estimated using the General Self-Efficacy Short Scale (GSE)(104 Weeks)
- Mean change in quality of life of the caregiver estimated with EQ-5D-5L(104 Weeks)
- User experience estimated with the UEQ-S(1 Hour)
- Change in status of the caregiver over time estimated with the daily caregiver status diary(12 Weeks)
- Adherence by days with no entry in the daily status diary(12 Weeks)
- Survival of the elderly participant based on the number of Grade 5 adverse events in the elderly participant estimated using an adverse event (AE) reporting form.(104 Weeks)
- Hospitalization rate, with the number of adverse events requiring hospitalization of the elderly participant estimated using an adverse event (AE) reporting form.(104 Weeks)
- Safety, with number of adverse events estimated using an adverse event (AE) reporting form.(104 Weeks)