Enhanced Post-discharge Home-based Care Program (EHP) for Stroke Survivors in Harbin China

The Hong Kong Polytechnic University

Status: Completed

Conditions: Stroke

Treatments: Other: EHP Group

Study type: Interventional

Funder types: Other

Identifiers

NCT03884621

5-ZH2Q

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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144 participants in 2 patient groups

EHP Group

Experimental group

Description:

The Enhanced post-discharge home-based care program (EHP) offers one coaching session upon hospital discharge and 12-week home follow-up (including 6 home visits, 6 telephone calls and 24-hour hotline) post hospital discharge to participants by an especially trained nurse case manager with the support of a clinical team. The five intervention protocols integrate with an individualized home-based rehabilitation training and self-care plan.

Treatment:

Other: EHP Group

Control Group

No Intervention group

Description:

Usual discharge care and post-discharge care provided to all stroke patients discharged home.