Study to determine whether the empowered stroke patients demonstrate better self-management behaviour and health outcomes
| ISRCTN | ISRCTN08913646 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08913646 |
| Secondary identifying numbers | 09100551 |
- Submission date
- 02/05/2012
- Registration date
- 06/06/2012
- Last edited
- 23/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
The Nethersole School of Nursing
Faculty of Medicine
The Chinese University of Hong Kong
-
-
Hong Kong
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study acronym | HEISS |
| Study objectives | 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(s) | Ethics Committee of Hong Kong East Cluster, Hospital Authority, ref: HKEC-2011-038 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 10/05/2012 |
| Completion date | 09/05/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 210 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/05/2012 |
| Date of final enrolment | 09/05/2014 |
Locations
Countries of recruitment
- Hong Kong
Study participating centre
-
Hong Kong
Sponsor information
Government
Health and Health Service Research Fund
Food and Health Bureau
-
-
Hong Kong
| Website | http://www.gov.hk/en/ |
|---|---|
"ROR" |
https://ror.org/034179816 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
23/06/2017: Plain English summary added.
