StrokeSESSMPNCT02112955
A Self-efficacy Enhancing Stroke Self-management Program for Community-dwelling Stroke Survivors
A study testing Stroke self-management program in people with Stroke, run by Queensland University of Technology at 3 sites in Hong Kong.
Trial summary
The aim of this study is to examine the effectiveness of a nurse-led self-efficacy enhancing stroke self-management program on recovery of community-dwelling 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?
- Stroke self-management program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 3 sitesHong Kong
- Study dates
- May 2014to May 2016
- 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 above
- have a clinical diagnosis of stroke
- currently live at home or will be discharged from hospital to home within one week
- have a Mini Mental State Examination score >18
- speak Cantonese
- capable of giving informed consent
- can attend sessions of the self-efficacy enhancing stroke self-management program
- can use a phone
Who cannot join
- diagnosed with transient ischemic attack, subdural or epidural hemorrhage
- have cerebrovascular events due to presence of malignancy or head trauma
- have limited comprehension and receptive aphasia
- have been diagnosed with schizophrenia, bipolar disorder, or dementia
- have received a stroke self-management program in the past 12 months as reported by the participants
Trial locations and contacts
3 sites in 1 country.
Hong Kong3 sites
Acute public hospital 1
Kowloon
Acute public hospital 2
New Territories
Acute public hospital 3
New Territories
About this study
Official title: A Randomized Controlled Trial of the Effectiveness of a Nurse-led Self-efficacy Enhancing Stroke Self-management Program for Community-dwelling Stroke Survivors
The aim of this study is to examine the effectiveness of a nurse-led self-efficacy enhancing stroke self-management program on recovery of community-dwelling stroke survivors.
Read the detailed description
Previous systematic reviews showed that theory-based stroke self-management programs had potential benefits in improving stroke survivors' quality of life and self-efficacy. However there is a lack of evidence evaluating the effectiveness of a nurse-led theory-based stroke self-management program among community-dwelling Chinese stroke survivors.
This is a parallel group, single-blinded, randomized controlled trial to be held in a community center. All participants will be assessed at two time-points (baseline before randomization, and one month after program completion). Eligible participants will be randomly allocated to either the control group (receiving usual care) or the intervention group (receiving the self-efficacy enhancing stroke self-management program). Participants in the intervention group will receive an additional assessment on usefulness of the program immediately after program completion.
- Conditions
- Stroke
- Being tested
- Stroke self-management program, Usual care
- Keywords
- Stroke, Disease management, Self efficacy, Quality of life, Community integration
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stroke self-management programBehavioural
A nurse-led community-based self-efficacy enhancing stroke self-management program.
Usual careBehavioural
Usual care such as hospital-based or community-based health education or services.
| Study group | Role | What they receive |
|---|---|---|
| Stroke self-management program | Experimental | The program is aimed at enhancing community-dwelling stroke survivors' post-stroke recovery. Receives: Behavioral: Stroke self-management program; Behavioral: Usual care |
| Usual care | Active comparator | Usual care provided to stroke survivors discharged to their home. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy in performing stroke self-management behaviors
Stroke Self-Efficacy Questionnaire
Measured: One month after the program
Secondary outcomes (5)
Stroke self-management behaviors
Stroke Self-management Behaviors Performance Scale
Measured: One month after the program
Health-related quality of life
Stroke Specific Quality of Life Scale
Measured: One month after the program
Depressive symptoms
Geriatric Depression Scale
Measured: One month after the program
Community reintegration
Reintegration to Normal Living Index
Measured: One month after the program
Outcome expectation
Stroke Self-management Outcome Expectation Scale
Measured: One month after the program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionJan 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queensland University of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzanne Hoi-Shan Lo, Queensland University of Technology
- Investigators
- Suzanne Lo, Principal investigator, Queensland University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112955
- Sponsor's protocol ID
- SESSMP01
- Acronym
- SESSMP
- Status last verified
- Nov 2016
- First submitted
- 9 Apr 2014
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
PubMed 34813082Lo SHS, Chang AM, Chau JPC. Stroke Self-Management Support Improves Survivors' Self-Efficacy and Outcome Expectation of Self-Management Behaviors. Stroke. 2018 Mar;49(3):758-760. doi: 10.1161/STROKEAHA.117.019437. Epub 2018 Feb 2.
PubMed 29438073Lo SH, Chang AM, Chau JP. Study protocol: a randomised controlled trial of a nurse-led community-based self-management programme for improving recovery among community-residing stroke survivors. BMC Health Serv Res. 2016 Aug 15;16(a):387. doi: 10.1186/s12913-016-1642-9.
PubMed 27528049
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Effectiveness of a Nurse-led Self-efficacy Enhancing Stroke Self-management Program for Community-dwelling Stroke Survivors
- ClinicalTrials.gov ID
- NCT02112955
- Acronym / sponsor ID
- SESSMP / SESSMP01
- Conditions
- Stroke
- Keywords
- Stroke, Disease management, Self efficacy, Quality of life, Community integration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Queensland University of TechnologyUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 14 Apr 2014 (estimated)
- 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.
The aim of this study is to examine the effectiveness of a nurse-led self-efficacy enhancing stroke self-management program on recovery of community-dwelling stroke survivors.
Detailed description
Previous systematic reviews showed that theory-based stroke self-management programs had potential benefits in improving stroke survivors' quality of life and self-efficacy. However there is a lack of evidence evaluating the effectiveness of a nurse-led theory-based stroke self-management program among community-dwelling Chinese stroke survivors.
This is a parallel group, single-blinded, randomized controlled trial to be held in a community center. All participants will be assessed at two time-points (baseline before randomization, and one month after program completion). Eligible participants will be randomly allocated to either the control group (receiving usual care) or the intervention group (receiving the self-efficacy enhancing stroke self-management program). Participants in the intervention group will receive an additional assessment on usefulness of the program immediately after program completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke self-management program | Experimental | Behavioral: Stroke self-management program, Behavioral: Usual careThe program is aimed at enhancing community-dwelling stroke survivors' post-stroke recovery. |
| Usual care | Active comparator | Behavioral: Usual careUsual care provided to stroke survivors discharged to their home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- aged 18 years or above
- have a clinical diagnosis of stroke
- currently live at home or will be discharged from hospital to home within one week
- have a Mini Mental State Examination score >18
- speak Cantonese
Key exclusion criteria (5 listed)
- diagnosed with transient ischemic attack, subdural or epidural hemorrhage
- have cerebrovascular events due to presence of malignancy or head trauma
- have limited comprehension and receptive aphasia
- have been diagnosed with schizophrenia, bipolar disorder, or dementia
- have received a stroke self-management program in the past 12 months as reported by the participants
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 |
|---|---|---|
| Stroke self-management programA nurse-led community-based self-efficacy enhancing stroke self-management program. | Behavioural | Stroke self-management program |
| Usual careUsual care such as hospital-based or community-based health education or services. | Behavioural | Stroke self-management program, Usual care |
Primary outcome
Self-efficacy in performing stroke self-management behaviors
Time frame: One month after the program
Stroke Self-Efficacy Questionnaire
5 secondary outcomes
Stroke self-management behaviors
Time frame: One month after the program
Health-related quality of life
Time frame: One month after the program
Depressive symptoms
Time frame: One month after the program
Community reintegration
Time frame: One month after the program
Outcome expectation
Time frame: One month after the program
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 9 Nov 2016.
- Derived from this study: PubMed 34813082Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
- Derived from this study: PubMed 29438073Lo SHS, Chang AM, Chau JPC. Stroke Self-Management Support Improves Survivors' Self-Efficacy and Outcome Expectation of Self-Management Behaviors. Stroke. 2018 Mar;49(3):758-760. doi: 10.1161/STROKEAHA.117.019437. Epub 2018 Feb 2.
- Derived from this study: PubMed 27528049Lo SH, Chang AM, Chau JP. Study protocol: a randomised controlled trial of a nurse-led community-based self-management programme for improving recovery among community-residing stroke survivors. BMC Health Serv Res. 2016 Aug 15;16(a):387. doi: 10.1186/s12913-016-1642-9.
- 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.
Suzanne Lo principal investigator
Queensland University of Technology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stroke self-management program in people with Stroke, run by Queensland University of Technology at 3 sites in Hong Kong.
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 8 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 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hong Kong. 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?
Self-efficacy in performing stroke self-management behaviors (time frame: One month after the program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02112955, which also lists 3 linked publications.
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 9 Nov 2016.