An Enhanced Post-discharge Home-based Care Program (EHP) to Improve the Quality of Life for Stroke Survivors in Harbin China: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Quality of life measured by the Stroke Impact Scale 3.0 (SIS 3.0)
研究概览
简要总结
In China, about 70% of stroke survivors are living with the negative consequences of stroke. Post stroke home-based care, a broad concept of rehabilitation, is an important care strategy to enhance recovery and improve quality of life for stroke survivors. However, home-based healthcare service is less available for patients discharged home from hospital. The investigators propose to develop and evaluate a home-based nursing intervention program to provide tailored and timely support to post-stroke patients returning to their daily livings at home after hospitalization. The enhanced post-discharge home-based care intervention is coupled with pre-discharge coaching and post-discharge home follow-up, focusing on functional recovery and self-care skills. This project has the potential to improve the quality of life and the related outcomes of stroke survivors, compared to usual care.
详细描述
This project will empirically test an innovated care delivery model, an enhanced post-discharge home-based care program (EHP) to address the challenges facing China on post-stroke care. The study will adopt a randomized controlled trial design to assess the effects of the EHP compared with usual care for post-discharged stroke survivors. Economic evaluation will be parallel with the trial.
Eligible participants will be recruited from the neurology units of a large general hospital in Harbin, China. Consented participants will be randomly assigned to receive either usual care or usual care plus EHP intervention. The EHP has two key components: pre-discharge coaching and post-discharge home follow-up which involves five intervention protocols for assessment, treatment and procedures, teaching, guidance and counselling, case management and surveillance, addressing on home-based rehabilitation training and self-care. The 12-week EHP will be provided by a trained nurse case manager with the support of a clinical team. All participants will be follow-up for 12 months with three assessments on study outcomes, including quality of life, self-efficacy, activities of daily living, anxiety and depression, adherence, satisfaction and healthcare utilization after baseline data collection. The incremental cost-effectiveness ratio and cost will also be calculated and compared between the two groups. In addition, focus group interviews will be conducted to gain an in-depth understanding of stakeholders' experience on post-stroke care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (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
- •Aged 18 years or over
- •Acute ischemic stroke diagnosed by a neurologist
- •National Institutes of Health Stroke Scale score ≥ 4 or <16
- •Modified Rankin Scale score 2 - 4
- •Discharged to their own home
- •Premorbid independence
- •being able to provide informed consent to participate in the study
排除标准
- •Global aphasia or expressive aphasia
- •Montreal Cognitive Assessment (MoCA-Beijing) score ≤ 22
- •Discharged to rehabilitation settings
- •At critical stage of illness or palliative treatment approach being provided
- •Conditions likely to interfere with rehabilitation
结局指标
主要结局
Quality of life measured by the Stroke Impact Scale 3.0 (SIS 3.0)
时间窗: Baseline, Day 90 (pre and post-intervention)
Change in quality of life from baseline to 90 days is measured using the Stroke Impact Scale 3.0 (SIS3.0), a stroke specific quality of life instrument. The SIS measures self-perceived health within eight domains (strength, hand functionality, activities of daily living, mobility, communication, emotions, memory and thinking, and participation) on a 5-point Likert scale. Scores for each domain are averaged and transformed into a score ranging from 0 to 100, and higher scores denote better health.
Quality of life measured by EuroQol-Visual Analogue Scale (EQ-VAS)
时间窗: Baseline, Day 90 (pre and post-intervention)
Change in quality of life from baseline to 90 days is measured using the EuroQol-Visual Analogue Scale (EQ-VAS). The EQ-VAS records the stroke survivor's self-rated health on a vertical visual analogue scale with end points of 0 (the worst health) and 100 (the best health).
Quality of life measured by EuroQol-Five Dimension Questionnaire
时间窗: Baseline, Day 90 (pre and post-intervention)
Change in quality of life from baseline to 90 days is measured using the EuroQol-Five Dimension Questionnaire (EQ-5D-5L), a generic health related quality of life instrument. The EuroQol-Five Dimension descriptive system covers five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five response levels; and the responses to 5 dimensions can be combined to provide a 5 digit profile describing the respondent's health state with a single index value. An EQ-5D-5L index score of 1 represents full health.
Quality of life measured by Stroke recovery score of the Stroke Impact Scale 3.0 (SIS 3.0)
时间窗: Baseline, Day 90 (pre and post-intervention)
Change in quality of life from baseline to 90 days is measured using the Stroke recovery score of the Stroke Impact Scale 3.0 (SIS3.0). The SIS 3.0 also includes a question to assess the patient's global perception of recovery on a visual scale of 0 (no recovery) to 100 (full recovery).
次要结局
- Quality of life measured by Stroke recovery score of the Stroke Impact Scale 3.0 (SIS 3.0)(Baseline, Day 180, Day 365 (follow-up))
- Independence of daily activities measured by the Modified Barthel Index (MBI)(Baseline, Day 180, Day 365 (follow-up))
- Quality of life measured by the Stroke Impact Scale 3.0 (SIS 3.0)(Baseline, Day 180, Day 365 (follow-up))
- Adherence to medication measured by the Adherence to Refills and Medication Scale (ARMS)(Baseline, Day 90 (pre and post-intervention))
- Quality of life measured by EuroQol-Five Dimension Questionnaire (EQ-5D-5L)(Baseline, Day 180, Day 365 (follow-up))
- Quality of life measured by EuroQol-Visual Analogue Scale (EQ-VAS)(Baseline, Day 180, Day 365 (follow-up))
- Self-Efficacy measured by the Self-Efficacy for Managing Chronic Disease 6-item Scale (SEMCD-6)(Baseline, Day 180, Day 365 (follow-up))
- Satisfaction level measured by the Patient Satisfaction with Care Questionnaire (PSCQ)(Day 90 (post-intervention))
- Anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS)(Baseline, Day 90 (pre and post-intervention))