A Multi-Site Trial of the Impact of Assistive Technology With Individuals With Mobility Limitations and Their Caregivers.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 240
- 试验地点
- 6
- 主要终点
- Caregiver Assistive Technology Outcome Measure
研究概览
简要总结
Many individuals with mobility limitations, especially those who are older and have more severe impairments, use a combination of assistive devices and personal assistance to meet their needs. Assistive technology (AT), which includes devices such as wheelchairs, walkers, bathroom grab bars, and dressing aids, helps facilitate day-to-day activities and social participation (basic and instrumental activities of daily living) among these individuals and may decrease their dependence on human assistance. Although some research has reported beneficial outcomes of AT use, few studies have used controlled experimental designs. Furthermore, the results are often difficult to interpret because the AT interventions are only vaguely described. Another concern is that many individuals receive help from others, but scant attention has been paid to the impact of AT on caregivers. This neglect produces an incomplete portrayal of the effect of AT interventions. The proposed study addresses these deficiencies by evaluating the effects of a formalized dyadic AT intervention on individuals with mobility limitations and on their caregivers. The Assistive Technology Provision, Updating and Training (ATPUT)intervention involves a detailed in-home assessment of participants' current AT; the negotiation and implementation of a personal AT plan with the participants and their caregivers; and the provision of AT devices, non-structural home modifications, and device training.
Objectives:
- To determine the efficacy of the Assistive Technology Provision, Updating and Training intervention for assistance users and for their caregivers.
- To explore how the intervention is experienced by these individuals and to help explain the study findings.
General Hypotheses:
The investigators anticipate this intervention will increase the daily activities and social participation of individuals with mobility limitations; decrease the psychological and physical demands on caregivers; and reduce the amount of caregiving required.
Methodologies:
This research will use a combination of quantitative and qualitative methods. The quantitative portion will be an experimental, single-blinded study in which the investigators randomly assign participants to either the ATPUT or a customary care group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •daily activity and/or mobility disability
- •referred to homecare
- •have an unpaid informal caregiver who is above the age of consent and willing to participate in the study
- •can communicate in English or French.
排除标准
- •cognitive impairments that are likely to prevent them from reliably completing the study questionnaires.
结局指标
主要结局
Caregiver Assistive Technology Outcome Measure
时间窗: 58 Weeks
The caregiver assistive technology outcome measure captures physical and psychological associated with informal care provision.
Functional Autonomy Measure (Système de mesure de l'autonomie fonctionnelle (SMAF))
时间窗: 58 weeks
A composite from two sub-scales of the SMAF will be used the primary outcome measure for users (self-care and mobility)
次要结局
- Qualitative interviews(week 6 and week 58)
- Sub-scale scores from the Functional Autonomy Measure (Système de mesure de l'autonomie fonctionnelle (SMAF))(baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3))
- Sub-scale scores from the Caregiver Assistive Technology Outcome Measure(baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).)
- Euro-QOL 5(baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).)
- Caregiver Burden Inventory(baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).)
- Reintegration to Normal Living Index (RNLI)(baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).)
- Self-report of Functional Independence(baseline (Time 0), week 6 (Time 1), week 22 (Time 2) and at week 58 (Time 3).)
研究者
Louise Demers
Directrice, Département de l'ergothérapie
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal