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

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ClinicalTrials.gov Identifier: NCT03884621
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
The Hong Kong Polytechnic University

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.

Condition or disease Intervention/treatment Phase
Stroke Other: EHP Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
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
Actual Study Start Date : September 25, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
Experimental: EHP Group
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
The Enhanced post-discharge home-based care program (EHP) plus usual care

No Intervention: Control Group
Usual discharge care and post-discharge care provided to all stroke patients discharged home.



Primary Outcome Measures :
  1. Quality of life measured by EuroQol-Five Dimension Questionnaire [ Time Frame: 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.

  2. Quality of life measured by EuroQol-Visual Analogue Scale (EQ-VAS) [ Time Frame: 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).

  3. Quality of life measured by the Stroke Impact Scale 3.0 (SIS 3.0) [ Time Frame: 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.

  4. Quality of life measured by Stroke recovery score of the Stroke Impact Scale 3.0 (SIS 3.0) [ Time Frame: 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).


Secondary Outcome Measures :
  1. Quality of life measured by EuroQol-Five Dimension Questionnaire (EQ-5D-5L) [ Time Frame: Baseline, Day 180, Day 365 (follow-up) ]
    Change in quality of life from baseline to 180 days or 365 days is measured using the EuroQol-Five Dimension Questionnaire (EQ-5D-5L), a generic health related quality of life instrument. The EQ-5D-5L 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.

  2. Quality of life measured by EuroQol-Visual Analogue Scale (EQ-VAS) [ Time Frame: Baseline, Day 180, Day 365 (follow-up) ]
    Change in quality of life from baseline to 180 days or 365 days is measured using the EuroQol-Visual Analogue Scale (EQ-VAS) , the second part of the EQ-5D-5L. 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).

  3. Quality of life measured by the Stroke Impact Scale 3.0 (SIS 3.0) [ Time Frame: Baseline, Day 180, Day 365 (follow-up) ]
    Change in quality of life from baseline to 180 days or 365 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.

  4. Quality of life measured by Stroke recovery score of the Stroke Impact Scale 3.0 (SIS 3.0) [ Time Frame: Baseline, Day 180, Day 365 (follow-up) ]
    Change in quality of life from baseline to 180 days or 365 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).

  5. Self-Efficacy measured by the Self-Efficacy for Managing Chronic Disease 6-item Scale (SEMCD-6) [ Time Frame: Baseline, Day 90 (pre and post-intervention) ]
    Change in Self-Efficacy from baseline to 90 days is evaluated by the Managing Chronic Disease 6-item Scale (SEMCD-6). The SEMCD-6 contains six items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident).

  6. Self-Efficacy measured by the Self-Efficacy for Managing Chronic Disease 6-item Scale (SEMCD-6) [ Time Frame: Baseline, Day 180, Day 365 (follow-up) ]
    Change in Self-Efficacy from baseline to 180 days or 365 days is evaluated by the Managing Chronic Disease 6-item Scale (SEMCD-6). The SEMCD-6 contains six items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident).

  7. Independence of daily activities measured by the Modified Barthel Index (MBI) [ Time Frame: Baseline, Day 90 (pre and post-intervention) ]
    Change in independence of daily activities from baseline to 90 days is evaluated by the Modified Barthel Index (MBI). The MBI is a 10-item, self-report measure to assess level of independence in ability to perform basic activities of daily living. Scale score ranges 0 - 100 with higher scores indicating greater independence in activities of daily living.

  8. Independence of daily activities measured by the Modified Barthel Index (MBI) [ Time Frame: Baseline, Day 180, Day 365 (follow-up) ]
    Change in independence of daily activities from baseline to 180 days or 365 days is evaluated by the Modified Barthel Index (MBI). The MBI is a 10-item, self-report measure to assess level of independence in ability to perform basic activities of daily living. Scale score ranges 0 - 100 with higher scores indicating greater independence in activities of daily living.

  9. Anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline, Day 90 (pre and post-intervention) ]
    Change in anxiety and depression from baseline to 90 days is evaluated by the Hospital Anxiety and Depression Scale (HADS). The HADS consists of two 7-item subscales measuring depression and anxiety. Items are rated on a four point scale (0-3) and the item scores are summed to give either a depression score or an anxiety score between 0 and 21. Higher score indicates higher levels of disorder.

  10. Adherence to medication measured by the Adherence to Refills and Medication Scale (ARMS) [ Time Frame: Baseline, Day 90 (pre and post-intervention) ]
    Change in adherence to medication from baseline to 90 days is assessed by the Adherence to Refills and Medication Scale (ARMS). The ARMS consists of two subscales, an 8- item medication taking subscale and a 4-item prescription refill subscale. Each item is given values from 1 to 4. An overall adherence score ranges from 12-48, with higher scores representing more problems with medication adherence.

  11. Satisfaction level measured by the Patient Satisfaction with Care Questionnaire (PSCQ) [ Time Frame: Day 90 (post-intervention) ]
    Satisfaction level in the time in completing the Patient Satisfaction Questionnaire at 90 days.


Other Outcome Measures:
  1. Healthcare utilization [ Time Frame: Enrollment to 90 days, 180 days and 365 days ]
    Combined number of emergency department visits, outpatient visits, rehabilitation center visits, hospitalizations, and days hospitalized per participant will be compared between the EHP group and control group with data collected by completing the Health Care Utilization and Cost Questionnaire (HCUCQ) at 90 days, 180 days and 365 days.

  2. Incremental cost-effectiveness ratio (for economic evaluation) [ Time Frame: Enrollment to 90 days, 180 days and 365 days ]
    Incremental cost-effectiveness ratio (ICER) calculated with data collected in completing the EQ-5D-5L and the HCUCQ questionnaires at 3 months, 6 months and 12 months. ICER = (Ci - Cc) / (Ei - Ec), where Ci and Ei are the cost and effect in the EHP group and where Cc and Ec are the cost and the effect in the control group.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884621


Contacts
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Contact: Frances KY Wong, PhD 852-27666419 frances.wong@polyu.edu.hk
Contact: Shaoling Wang, PhD 852-34003800 shaoling.wang@polyu.edu.hk

Locations
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China, Heilongjiang
The First Hospital of Harbin Recruiting
Harbin, Heilongjiang, China, 150010
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
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Principal Investigator: Frances Wong, PhD School of Nursing, The Hong Kong Polytechnic University
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Responsible Party: The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03884621    
Other Study ID Numbers: 5-ZH2Q
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Hong Kong Polytechnic University:
continuity of patient care
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases