StrokePEPSNCT01112488
Patient Engagement Program for Stroke - Pilot Study
A study testing Patient Engagement Programme in people with Stroke and Rehabilitation, run by Kowloon Hospital, Hong Kong at 1 site in China.
Trial summary
Currently there is a lot of literatures on stroke rehabilitation and post-discharge therapy. However, there are few evidence based guidelines on patient engagement after stroke in the post-rehabilitation community phase. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Rehabilitation
- What is being tested?
- Patient Engagement Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- May 2010to Dec 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A stroke patient being discharged from a rehabilitation unit planned to be discharged to community with new carer
Who cannot join
- plan to enter institution within 3 months of discharge
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Rehabilitation, Kowloon Hospital
Hong Kong
Mandy PM Fung, FHKCP, 31297111 ext. 7830, fungpm1@ha.org.hk
About this study
Currently there is a lot of literatures on stroke rehabilitation and post-discharge therapy. However, there are few evidence based guidelines on patient engagement after stroke in the post-rehabilitation community phase. There is evidence from stroke studies that stroke patients with mild to moderate disability, discharged early from an acute hospital unit can be rehabilitated in the community by an interdisciplinary stroke rehabilitation team and attain similar functional outcomes when compared to patients receiving in-patient rehabilitation. There is strong evidence that additional hospital based outpatient therapy improves short term functional outcomes compared to routine care over short term. Although meta-analyses have examined the efficacy of self management education programs, the interpretation of such reviews is limited by heterogeneity in populations and interventions and the limited range of outcomes measured. Few randomized controlled trials have found a reduction in health service utilization, such as incidences of hospitalization (in patients with chronic lung disease, heart disease, stroke and arthritis) as a direct outcome of attending an education program. For self-management support to be effective and sustainable in the community, it is postulated that initiatives simultaneously focus on supporting patients to engage in self management and equipping health care professionals with the necessary resources to assist them.
Read the detailed description
This is a randomized controlled pilot study of a post discharge community based patient engagement program for stroke patients discharged with a new carer after a period of in-hospital rehabilitation. Potential cases are identified within 2 weeks after admission into rehabilitation wards and randomized into either intervention group or usual care (control) group. Patients undergo the usual pre-discharge planning while in ward with predischarge assessment carried out by an independent (blinded) assessor. The control group are referred to receive the usual post-discharge community and rehabilitation backup. The intervention group has access to a special telephone hotline, home visits by team member within 1 week after discharge, patient diary to record home monitoring and back up of a specialist lead patient engagement clinic located in Kowloon Hospital. After 12 weeks, another home visit will be arranged for a repeat assessment by an independent (blinded) assessor. The outcomes to be measured include service parameters such as unplanned medical readmissions, AED attendances, length of stay at acute and rehabilitation units. Patient related parameters such as mortality, institutionalization, functional outcomes, mood, quality of life and complications will be measured as well as a carer strain and satisfaction survey.
- Conditions
- Stroke, Rehabilitation
- Being tested
- Patient Engagement Programme
- Keywords
- stroke, patient engagement programme, community rehabilitation, new carer
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Engagement ProgrammeOther
Patient's Diary, Ad Hoc medical support and Ad Hoc Clinical admission, Early post discharge Home visit
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | usual care |
| multidisciplinary intervention | Experimental | Patient engagement Programme Receives: Other: Patient Engagement Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unplanned Medical readmissions
Measured: 3 months
Length of hospital stay
Measured: 3 months
Emergency Department attendance rate
Measured: 3 months
Secondary outcomes (8)
Carer and Patient Satisfactory Survey
Measured: 3 months
Carer Strain Index
Measured: 3months
Medical complications
Measured: 3 months
Functional Independence Measure
Measured: 3 months
Barthel Index
Measured: 3 months
Modified Rivermead Mobility Index
Measured: 3 months
Modified Ashworth Score
Measured: 3 months
Geriatric Geriatric Depression Scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kowloon Hospital, Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Mandy PM Fung, FHKCP, Principal investigator, Department of Rehabilitaiton, Kowloon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112488
- Sponsor's protocol ID
- PEPS
- Acronym
- PEPS
- Status last verified
- Mar 2010
- First submitted
- 22 Apr 2010
- Last updated
- 28 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Engagement Program for Stroke - Pilot Study
- ClinicalTrials.gov ID
- NCT01112488
- Acronym / sponsor ID
- PEPS / PEPS
- Conditions
- Stroke, Rehabilitation
- Keywords
- stroke, patient engagement programme, community rehabilitation, new carer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kowloon Hospital, Hong KongUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 28 Apr 2010 (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.
Currently there is a lot of literatures on stroke rehabilitation and post-discharge therapy. However, there are few evidence based guidelines on patient engagement after stroke in the post-rehabilitation community phase. There is evidence from stroke studies that stroke patients with mild to moderate disability, discharged early from an acute hospital unit can be rehabilitated in the community by an interdisciplinary stroke rehabilitation team and attain similar functional outcomes when compared to patients receiving in-patient rehabilitation. There is strong evidence that additional hospital based outpatient therapy improves short term functional outcomes compared to routine care over short term. Although meta-analyses have examined the efficacy of self management education programs, the interpretation of such reviews is limited by heterogeneity in populations and interventions and the limited range of outcomes measured. Few randomized controlled trials have found a reduction in health service utilization, such as incidences of hospitalization (in patients with chronic lung disease, heart disease, stroke and arthritis) as a direct outcome of attending an education program. For self-management support to be effective and sustainable in the community, it is postulated that initiatives simultaneously focus on supporting patients to engage in self management and equipping health care professionals with the necessary resources to assist them.
Detailed description
This is a randomized controlled pilot study of a post discharge community based patient engagement program for stroke patients discharged with a new carer after a period of in-hospital rehabilitation. Potential cases are identified within 2 weeks after admission into rehabilitation wards and randomized into either intervention group or usual care (control) group. Patients undergo the usual pre-discharge planning while in ward with predischarge assessment carried out by an independent (blinded) assessor. The control group are referred to receive the usual post-discharge community and rehabilitation backup. The intervention group has access to a special telephone hotline, home visits by team member within 1 week after discharge, patient diary to record home monitoring and back up of a specialist lead patient engagement clinic located in Kowloon Hospital. After 12 weeks, another home visit will be arranged for a repeat assessment by an independent (blinded) assessor. The outcomes to be measured include service parameters such as unplanned medical readmissions, AED attendances, length of stay at acute and rehabilitation units. Patient related parameters such as mortality, institutionalization, functional outcomes, mood, quality of life and complications will be measured as well as a carer strain and satisfaction survey.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –usual care |
| multidisciplinary intervention | Experimental | Other: Patient Engagement ProgrammePatient engagement Programme |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- A stroke patient being discharged from a rehabilitation unit planned to be discharged to community with new carer
Key exclusion criteria (1 listed)
- plan to enter institution within 3 months of discharge
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 |
|---|---|---|
| Patient Engagement ProgrammePatient's Diary, Ad Hoc medical support and Ad Hoc Clinical admission, Early post discharge Home visit | Other | multidisciplinary intervention |
Primary outcome
Unplanned Medical readmissions
Time frame: 3 months
Length of hospital stay
Time frame: 3 months
Emergency Department attendance rate
Time frame: 3 months
8 secondary outcomes
Carer and Patient Satisfactory Survey
Time frame: 3 months
Carer Strain Index
Time frame: 3months
Medical complications
Time frame: 3 months
Functional Independence Measure
Time frame: 3 months
Barthel Index
Time frame: 3 months
Modified Rivermead Mobility Index
Time frame: 3 months
Modified Ashworth Score
Time frame: 3 months
Geriatric Geriatric Depression Scale
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2010.
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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.
Mandy PM Fung, FHKCP principal investigator
Department of Rehabilitaiton, Kowloon Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Engagement Programme in people with Stroke and Rehabilitation, run by Kowloon Hospital, Hong Kong 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Apr 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unplanned Medical readmissions (time frame: 3 months). The study lists 3 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 28 Apr 2010.