Patient Engagement Program for Stroke - Pilot Study (PEPS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Kowloon Hospital, Hong Kong.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Kowloon Hospital, Hong Kong
ClinicalTrials.gov Identifier:
NCT01112488
First received: April 22, 2010
Last updated: April 27, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention
Stroke
Rehabilitation
Other: Patient Engagement Programme

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Patient Engagement Program for Stroke - Pilot Study

Resource links provided by NLM:


Further study details as provided by Kowloon Hospital, Hong Kong:

Primary Outcome Measures:
  • Unplanned Medical readmissions [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Emergency Department attendance rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Carer and Patient Satisfactory Survey [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Carer Strain Index [ Time Frame: 3months ] [ Designated as safety issue: No ]
  • Medical complications [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Functional Independence Measure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Barthel Index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Modified Rivermead Mobility Index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Modified Ashworth Score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Geriatric Geriatric Depression Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
usual care
Experimental: multidisciplinary intervention
Patient engagement Programme
Other: Patient Engagement Programme
Patient's Diary, Ad Hoc medical support and Ad Hoc Clinical admission, Early post discharge Home visit

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112488

Locations
China
Department of Rehabilitation, Kowloon Hospital Not yet recruiting
Hong Kong, China
Contact: Mandy PM Fung, FHKCP    31297111 ext 7830    fungpm1@ha.org.hk   
Sponsors and Collaborators
Kowloon Hospital, Hong Kong
Investigators
Principal Investigator: Mandy PM Fung, FHKCP Department of Rehabilitaiton, Kowloon Hospital
  More Information

No publications provided

Responsible Party: Dr. Fung Pui Man, Senior Medical Officer, Department of Rehabilitation, Kowloon Hospital
ClinicalTrials.gov Identifier: NCT01112488     History of Changes
Other Study ID Numbers: PEPS
Study First Received: April 22, 2010
Last Updated: April 27, 2010
Health Authority: HongKong, China: Research Ethics Committee (Kowloon Central / Kowloon East)

Keywords provided by Kowloon Hospital, Hong Kong:
stroke
patient engagement programme
community rehabilitation
new carer

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 16, 2014