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临床试验/NCT02230280
NCT02230280已完成不适用

Strengthening Community-Based Stroke Care: A Pilot Study of a Community Navigation and Rehabilitation Intervention That Includes a Mobile Health Solution

McMaster University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年5月8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
30
试验地点
1
主要终点
Changes in health-related quality of life (HRQoL) for both stroke survivors and caregivers as measured by the SF-12

研究概览

简要总结

Most stroke survivors live with other chronic health conditions that can negatively affect their recovery and overall health and well-being. Although stroke care has improved, there are still many challenges to the delivery of community-based stroke care. These challenges include: poor coordination of care across health care providers and settings; limited communication among health care providers; limited use of evidence-based treatment guidelines; difficulties navigating community services and supports; and limited client and family caregiver involvement in making healthcare decisions. The investigators developed a new mobile health (mHealth) application, My Stroke Team (MYST), to address these challenges to improve the overall quality of stroke care at home. This study will expand this work to: 1) explore the feasibility and acceptability of this mobile tool, 2) determine its impact and usability for home care providers, stroke survivors, and their family caregivers, and 3) determine its impact on the costs of use of health services.

详细描述

Research Questions:

  1. What is the feasibility and acceptability of the MYST app within the context of a 6-month community navigation and rehabilitation intervention from the perspectives of health care providers, clients, and family caregivers?
  2. What are the MYST app usage patterns by various subgroups of end-users (e.g., clients, health-care providers, age groups of HCPs, stroke survivors and family caregivers)?
  3. What is the effect of the intervention on stroke survivors' health-related quality of life, community re-integration, physical functioning, depression, anxiety, self-efficacy, and costs of use of health services, from a societal perspective?
  4. What is the effect of the intervention on family caregivers' health-related quality of life, caregiver strain, depression, anxiety, and costs of use of health services from a societal perspective?
  5. What is the effect of the intervention on HCP outcomes (interprofessional collaboration)?

Methods:

Due to the complexity of evaluating health services interventions, a mixed methods design will be used to evaluate the multi-component intervention. A pragmatic pre-test post-test single site study design will be used to evaluate the intervention. By pragmatic, the investigators mean the intervention will be implemented under real-world conditions, including reliance on existing staff at the participating site. Assessments will be made at baseline (pre-test) and immediately following the six-month intervention period (post-test). Descriptive qualitative methods will be used to explore the feasibility and acceptability of the intervention.

Outcomes will be assessed at baseline and 6 months. Summary descriptive measures will be reported for all variables.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

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

  • •Participants are newly referred for outpatient rehabilitation with a confirmed diagnosis of stroke (first ever or recurrent) within the past 12 months, and are not planning to move away from the community in the next 6 months. Participants have at least 2 predetermined comorbid conditions, and must have the capacity to provide informed consent, either independently or by substitute decision maker.

排除标准

  • •Participants will be excluded if they are unable to read and understand English and do not have access to a translator.

研究组 & 干预措施

The intervention cohort.

Other

A community transition and rehabilitation intervention that includes a mobile health solution

干预措施: Strengthening Community-Based Stroke Care: A Pilot Study of a Community Navigation and Rehabilitation Intervention that Includes a Mobile Health Solution (Other)

结局指标

主要结局

Changes in health-related quality of life (HRQoL) for both stroke survivors and caregivers as measured by the SF-12

时间窗: Baseline and the end of the intervention (6 months from baseline)

The Short-Form 12(SF-12) Health Survey will be administered to stroke survivors and caregivers to measure health-related quality of life

Feasibility of the mobile application as part of the intervention.

时间窗: At the end of the intervention (6 months)

Participants' perspectives on the feasibility of the mobile application will be assessed qualitatively through focus groups (HCPs) and interviews (stroke survivors and family caregivers).

次要结局

  • Changes in the degree of physical functioning related to stroke.(Baseline and the end of the intervention (6 months from baseline))
  • Change in the costs of use of health services by stroke survivors and family caregivers(Baseline and end of intervention (6 months from baseline))
  • Change in prevalence and severity of anxiety.(Baseline and end of intervention (6 months from baseline))
  • Change in the self efficacy of stroke survivors.(Baseline and end of the intervention (6 months from baseline))
  • Change in the community integration of stroke patients.(Baseline and end of the intervention (6 months from baseline))
  • Change in team functioning.(At three months into the intervention study and upon completion of the study (16 months))
  • Change in the prevalence and severity of depression symptoms in stroke survivors and family caregivers.(Baseline and the end of the intervention (6 months from baseline))
  • Change in the degree of strain of family caregiver.(Baseline and the end of the intervention (6months from baseline))
  • Change in level of integration between home care providers.(At three months into the intervention study and upon completion of the study (16 months))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maureen Markle-Reid

Associate Professor and Canada Research Chair

McMaster University

研究点 (1)

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My Stroke Team (MYST): Stroke App Pilot Study | 临床试验