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

NCT03884621 | Completed DMC

• 1 other identifier: 5-ZH2Q
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

continuity of patient care

Outcome Measures

Primary Outcomes (4)

• Quality of life measured by EuroQol-Five Dimension Questionnaire

  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.

  Baseline, Day 90 (pre and post-intervention)

• Quality of life measured by EuroQol-Visual Analogue Scale (EQ-VAS)

  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).

  Baseline, Day 90 (pre and post-intervention)

• Quality of life measured by the Stroke Impact Scale 3.0 (SIS 3.0)

  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.

  Baseline, Day 90 (pre and post-intervention)

• Quality of life measured by Stroke recovery score of the Stroke Impact Scale 3.0 (SIS 3.0)

  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).

  Baseline, Day 90 (pre and post-intervention)

Secondary Outcomes (11)

• 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)

• Quality of life measured by the Stroke Impact Scale 3.0 (SIS 3.0)

  Baseline, Day 180, Day 365 (follow-up)

• 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)

• Self-Efficacy measured by the Self-Efficacy for Managing Chronic Disease 6-item Scale (SEMCD-6)

  Baseline, Day 90 (pre and post-intervention)

Other Outcomes (2)

• Healthcare utilization

  Enrollment to 90 days, 180 days and 365 days

• Incremental cost-effectiveness ratio (for economic evaluation)

  Enrollment to 90 days, 180 days and 365 days

Study Arms (2)

EHP Group

EXPERIMENTAL

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.

Other: EHP Group

Control Group

NO INTERVENTION

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

Interventions

EHP Group OTHER

The Enhanced post-discharge home-based care program (EHP) plus usual care

EHP Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The First Hospital of Harbin

Harbin, Heilongjiang, 150010, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Frances Wong, PhD

  School of Nursing, The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 21, 2019
• Study Start: September 25, 2018
• Primary Completion: November 27, 2020
• Study Completion: November 27, 2020
• Last Updated: December 19, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)