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Patient Engagement Program for Stroke - Pilot Study (PEPS)

Primary Purpose

Stroke, Rehabilitation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Patient Engagement Programme
Sponsored by
Kowloon Hospital, Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke focused on measuring stroke, patient engagement programme, community rehabilitation, new carer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Rehabilitation, Kowloon Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

multidisciplinary intervention

Arm Description

usual care

Patient engagement Programme

Outcomes

Primary Outcome Measures

Unplanned Medical readmissions
Length of hospital stay
Emergency Department attendance rate

Secondary Outcome Measures

Carer and Patient Satisfactory Survey
Carer Strain Index
Medical complications
Functional Independence Measure
Barthel Index
Modified Rivermead Mobility Index
Modified Ashworth Score
Geriatric Geriatric Depression Scale

Full Information

First Posted
April 22, 2010
Last Updated
April 27, 2010
Sponsor
Kowloon Hospital, Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01112488
Brief Title
Patient Engagement Program for Stroke - Pilot Study
Acronym
PEPS
Official Title
Patient Engagement Program for Stroke - Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Kowloon Hospital, Hong Kong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Rehabilitation
Keywords
stroke, patient engagement programme, community rehabilitation, new carer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
usual care
Arm Title
multidisciplinary intervention
Arm Type
Experimental
Arm Description
Patient engagement Programme
Intervention Type
Other
Intervention Name(s)
Patient Engagement Programme
Intervention Description
Patient's Diary, Ad Hoc medical support and Ad Hoc Clinical admission, Early post discharge Home visit
Primary Outcome Measure Information:
Title
Unplanned Medical readmissions
Time Frame
3 months
Title
Length of hospital stay
Time Frame
3 months
Title
Emergency Department attendance rate
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Carer and Patient Satisfactory Survey
Time Frame
3 months
Title
Carer Strain Index
Time Frame
3months
Title
Medical complications
Time Frame
3 months
Title
Functional Independence Measure
Time Frame
3 months
Title
Barthel Index
Time Frame
3 months
Title
Modified Rivermead Mobility Index
Time Frame
3 months
Title
Modified Ashworth Score
Time Frame
3 months
Title
Geriatric Geriatric Depression Scale
Time Frame
3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mandy PM Fung, FHKCP
Organizational Affiliation
Department of Rehabilitaiton, Kowloon Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rehabilitation, Kowloon Hospital
City
Hong Kong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mandy PM Fung, FHKCP
Phone
31297111
Ext
7830
Email
fungpm1@ha.org.hk

12. IPD Sharing Statement

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Patient Engagement Program for Stroke - Pilot Study

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