StrokeNCT03884621
Enhanced Post-discharge Home-based Care Program (EHP) for Stroke Survivors in Harbin China
A study testing EHP Group in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- EHP Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2018to 27 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- EHP Group
- Keywords
- continuity of patient care
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EHP GroupOther
The Enhanced post-discharge home-based care program (EHP) plus usual care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: EHP Group |
| Control Group | No intervention | Usual discharge care and post-discharge care provided to all stroke patients discharged home. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: Baseline, Day 90 (pre and post-intervention)
Secondary outcomes (11)
Quality of life measured by EuroQol-Five Dimension Questionnaire (EQ-5D-5L)
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.
Measured: Baseline, Day 180, Day 365 (follow-up)
Quality of life measured by EuroQol-Visual Analogue Scale (EQ-VAS)
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).
Measured: Baseline, Day 180, Day 365 (follow-up)
Quality of life measured by the Stroke Impact Scale 3.0 (SIS 3.0)
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.
Measured: 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)
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).
Measured: Baseline, Day 180, Day 365 (follow-up)
Self-Efficacy measured by the Self-Efficacy for Managing Chronic Disease 6-item Scale (SEMCD-6)
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).
Measured: Baseline, Day 90 (pre and post-intervention)
Self-Efficacy measured by the Self-Efficacy for Managing Chronic Disease 6-item Scale (SEMCD-6)
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).
Measured: Baseline, Day 180, Day 365 (follow-up)
Independence of daily activities measured by the Modified Barthel Index (MBI)
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.
Measured: Baseline, Day 90 (pre and post-intervention)
Independence of daily activities measured by the Modified Barthel Index (MBI)
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.
Measured: Baseline, Day 180, Day 365 (follow-up)
Anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS)
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.
Measured: Baseline, Day 90 (pre and post-intervention)
Adherence to medication measured by the Adherence to Refills and Medication Scale (ARMS)
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.
Measured: Baseline, Day 90 (pre and post-intervention)
Satisfaction level measured by the Patient Satisfaction with Care Questionnaire (PSCQ)
Satisfaction level in the time in completing the Patient Satisfaction Questionnaire at 90 days.
Measured: Day 90 (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start25 Sep 2018
- Primary completion27 Nov 2020
- Study completion27 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frances Wong, PhD, Principal investigator, School of Nursing, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884621
- Sponsor's protocol ID
- 5-ZH2Q
- Status last verified
- Aug 2020
- First submitted
- 4 Mar 2019
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03884621
- Acronym / sponsor ID
- 5-ZH2Q
- Conditions
- Stroke
- Keywords
- continuity of patient care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 27 Nov 2020 (actual)
- Study completion
- 27 Nov 2020 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EHP Group | Experimental | Other: EHP GroupThe 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. |
| Control Group | No intervention | –Usual discharge care and post-discharge care provided to all stroke patients discharged home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EHP GroupThe Enhanced post-discharge home-based care program (EHP) plus usual care | Other | EHP Group |
Primary outcome
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.
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).
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.
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).
11 secondary outcomes
Quality of life measured by EuroQol-Five Dimension Questionnaire (EQ-5D-5L)
Time frame: Baseline, Day 180, Day 365 (follow-up)
Quality of life measured by EuroQol-Visual Analogue Scale (EQ-VAS)
Time frame: Baseline, Day 180, Day 365 (follow-up)
Quality of life measured by the Stroke Impact Scale 3.0 (SIS 3.0)
Time frame: 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)
Time frame: Baseline, Day 180, Day 365 (follow-up)
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)
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)
Independence of daily activities measured by the Modified Barthel Index (MBI)
Time frame: Baseline, Day 90 (pre and post-intervention)
Independence of daily activities measured by the Modified Barthel Index (MBI)
Time frame: Baseline, Day 180, Day 365 (follow-up)
Anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, Day 90 (pre and post-intervention)
Adherence to medication measured by the Adherence to Refills and Medication Scale (ARMS)
Time frame: Baseline, Day 90 (pre and post-intervention)
Satisfaction level measured by the Patient Satisfaction with Care Questionnaire (PSCQ)
Time frame: Day 90 (post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frances Wong, PhD principal investigator
School of Nursing, The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EHP Group in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life measured by EuroQol-Five Dimension Questionnaire (time frame: Baseline, Day 90 (pre and post-intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.