Plain English Summary
Background and study aims
A stroke is a serious condition that occurs when the blood supply to part of the brain is cut off. People who survive a stroke are often left with long-term problems caused by injury to their brain, and some need a long period of rehabilitation before they can recover their former independence. The aim of this study is to assess the effects of a Health Empowerment Intervention for Stroke Self-management (HEISS) on the self-management behaviour and health outcomes of stroke rehabilitation patients.
Who can participate?
Stroke patients aged over 18 who are experiencing functional difficulties
What does the study involve?
Participants are randomly allocated to either the control group receiving usual care or the treatment group receiving HEISS. Usual care is the current stroke rehabilitation programme. HEISS, in addition to the usual care, is designed to empower patients with the knowledge and skills to practice self-management in the stroke rehabilitation journey. The emphasis is on patients’ perspective, taking into account their available resources, needs and preference, to set behavioural goals and an action plan for the highest possible self-care independence. The control group and the treatment group are compared in terms self-efficacy, engagement in self-management behaviours, ability to do daily activities, quality of life, unplanned hospital re-admissions and stroke recurrence. Data is collected at the start of the study and after 1 week, 3 months and 6 months.
What are the possible benefit and risks of participating?
Participants should benefit from HEISS by acquiring essential knowledge and skills, building self-efficacy in self-care performance after stroke, and establishing a supportive relationship with their significant others in the stroke recovery process. The study’s findings should provide directions for bridging hospital and community care for stroke rehabilitation patients. There should be no direct risk or harm from participating in the study except participants may experience tiredness or reduced concentration from prolonged small group interactions. Therefore, the study runs at a short duration (around 20 minutes per session per week) with a short break scheduled according to participants’ needs.
Where is the study run from?
The Chinese University of Hong Kong
When is the study starting and how long is it expected to run for?
May 2012 to May 2014
Who is funding the study?
Health Service Research Fund of the Food and Health Bureau, Hong Kong Government
Who is the main contact?
Dr Janet W.H. Sit
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
09100551
Study information
Scientific title
The effect of a Health Empowerment Intervention for Stroke Self-management (HEISS) on the self-management behaviour and health outcomes of stroke rehabilitation patients
Acronym
HEISS
Study hypothesis
Compared with the control group, participants in HEISS will have a significant improvement in:
1. Self-efficacy
2. Self-management behaviour
3. Functional ability in activities of daily living
Null hypothesis:
There will be no difference between control group and treatment group in the above three outcomes.
Ethics approval
Ethics Committee of Hong Kong East Cluster, Hospital Authority, ref: HKEC-2011-038
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Stroke post-acute stage
Intervention
Participants will be randomised to either the control group receiving usual care or the treatment group receiving HEISS
HEISS is based on the Theory of Health Empowerment. It consists of:
Part I: Six weekly small group sessions (20 mins per session and 4-6 participants per group). On completion of the 6 sessions, an individualized mutually agreed action plan and Stroke Self-management Work Book will be made for individual home-based implementation.
Part II: Home-based implementation of the action plan with two nurse reinforcement telephone follow-ups.
Part III: A small group re-union session after the individual home-based implementation (20 mins with the same group composition as in Part I). The purpose is to facilitate personal reflection and experience sharing.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Self-efficacy
2. Engagement in self-management behaviour
3. Functional ability in activities of daily living (ADLs)
Measured pre-test, 1-week, 3-month and 6-month post-test
Secondary outcome measures
1. Quality of life
2. Unplanned hospital re-admission rate
3. Stroke recurrent rate
Overall trial start date
10/05/2012
Overall trial end date
09/05/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients who experience stroke (haemorrhagic or ischaemic) as diagnosed by medical doctors, currently admitted to the ambulatory stroke rehabilitation programme with no pre-morbid disability
2. Experiencing post-stroke functional difficulties that limit participation in self-care activities
3. Aged over 18, with Chinese ethnicity and Cantonese dialect communicability
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
210
Participant exclusion criteria
1. Patients with aphasia and/or cognitive decline [minimental state examination (MMSE)<18] that are severe enough to affect participation in the intervention
2. Patients who are currently diagnosed to have depression
Recruitment start date
10/05/2012
Recruitment end date
09/05/2014
Locations
Countries of recruitment
Hong Kong
Trial participating centre
The Chinese University of Hong Kong
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-
Hong Kong
Sponsor information
Organisation
Hong Kong SAR Government (Hong Kong)
Sponsor details
Health and Health Service Research Fund
Food and Health Bureau
-
-
Hong Kong
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Health Service Research Fund - Hong Kong SAR Government (Hong Kong) ref: 09100551
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary