- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01112488
Patient Engagement Program for Stroke - Pilot Study (PEPS)
April 27, 2010 updated by: Kowloon Hospital, Hong Kong
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hong Kong, China
- Department of Rehabilitation, Kowloon Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- A stroke patient being discharged from a rehabilitation unit planned to be discharged to community with new carer
Exclusion Criteria:
- plan to enter institution within 3 months of discharge
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
usual care
|
|
|
Experimental: multidisciplinary intervention
Patient engagement Programme
|
Patient's Diary, Ad Hoc medical support and Ad Hoc Clinical admission, Early post discharge Home visit
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Length of hospital stay
Time Frame: 3 months
|
3 months
|
|
Unplanned Medical readmissions
Time Frame: 3 months
|
3 months
|
|
Emergency Department attendance rate
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Barthel Index
Time Frame: 3 months
|
3 months
|
|
Carer and Patient Satisfactory Survey
Time Frame: 3 months
|
3 months
|
|
Carer Strain Index
Time Frame: 3months
|
3months
|
|
Medical complications
Time Frame: 3 months
|
3 months
|
|
Functional Independence Measure
Time Frame: 3 months
|
3 months
|
|
Modified Rivermead Mobility Index
Time Frame: 3 months
|
3 months
|
|
Modified Ashworth Score
Time Frame: 3 months
|
3 months
|
|
Geriatric Geriatric Depression Scale
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mandy PM Fung, FHKCP, Department of Rehabilitaiton, Kowloon Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Anticipated)
December 1, 2010
Study Completion (Anticipated)
December 1, 2010
Study Registration Dates
First Submitted
April 22, 2010
First Submitted That Met QC Criteria
April 27, 2010
First Posted (Estimate)
April 28, 2010
Study Record Updates
Last Update Posted (Estimate)
April 28, 2010
Last Update Submitted That Met QC Criteria
April 27, 2010
Last Verified
March 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEPS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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