Clinical trial NCT03884621: Enhanced Post-discharge Home-based Care Program (EHP) for Stroke Survivors in Harbin China
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: continuity of patient care
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Quality of life measured by EuroQol-Five Dimension Questionnaire
timeFrame: Baseline, Day 90 (pre and post-intervention)
measure: Quality of life measured by EuroQol-Visual Analogue Scale (EQ-VAS)
timeFrame: Baseline, Day 90 (pre and post-intervention)
measure: Quality of life measured by the Stroke Impact Scale 3.0 (SIS 3.0)
timeFrame: Baseline, Day 90 (pre and post-intervention)
measure: Quality of life measured by Stroke recovery score of the Stroke Impact Scale 3.0 (SIS 3.0)
timeFrame: Baseline, Day 90 (pre and post-intervention)
Secondary outcomes:
measure: Quality of life measured by EuroQol-Five Dimension Questionnaire (EQ-5D-5L)
timeFrame: Baseline, Day 180, Day 365 (follow-up)
measure: Quality of life measured by EuroQol-Visual Analogue Scale (EQ-VAS)
timeFrame: Baseline, Day 180, Day 365 (follow-up)
measure: Quality of life measured by the Stroke Impact Scale 3.0 (SIS 3.0)
timeFrame: Baseline, Day 180, Day 365 (follow-up)
measure: Quality of life measured by Stroke recovery score of the Stroke Impact Scale 3.0 (SIS 3.0)
timeFrame: Baseline, Day 180, Day 365 (follow-up)
measure: Self-Efficacy measured by the Self-Efficacy for Managing Chronic Disease 6-item Scale (SEMCD-6)
timeFrame: Baseline, Day 90 (pre and post-intervention)
measure: Self-Efficacy measured by the Self-Efficacy for Managing Chronic Disease 6-item Scale (SEMCD-6)
timeFrame: Baseline, Day 180, Day 365 (follow-up)
measure: Independence of daily activities measured by the Modified Barthel Index (MBI)
timeFrame: Baseline, Day 90 (pre and post-intervention)
measure: Independence of daily activities measured by the Modified Barthel Index (MBI)
timeFrame: Baseline, Day 180, Day 365 (follow-up)
measure: Anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, Day 90 (pre and post-intervention)
measure: Adherence to medication measured by the Adherence to Refills and Medication Scale (ARMS)
timeFrame: Baseline, Day 90 (pre and post-intervention)
measure: Satisfaction level measured by the Patient Satisfaction with Care Questionnaire (PSCQ)
timeFrame: Day 90 (post-intervention)
Other outcomes:
measure: Healthcare utilization
timeFrame: Enrollment to 90 days, 180 days and 365 days
measure: Incremental cost-effectiveness ratio (for economic evaluation)
timeFrame: Enrollment to 90 days, 180 days and 365 days
Locations:
city: Harbin
country: China
facility: The First Hospital of Harbin
state: Heilongjiang
Study officials:
affiliation: School of Nursing, The Hong Kong Polytechnic University
name: Frances Wong, PhD
role: PRINCIPAL_INVESTIGATOR
References: