Patient Engagement Program for Stroke - Pilot Study

Stroke Clinical Trial

— PEPS  

Official title:

Patient Engagement Program for Stroke - Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01112488
• Other study ID #: PEPS
• Status: Not yet recruiting
• Phase: N/A
• First received: April 22, 2010
• Last updated: April 27, 2010
• Start date: May 2010
• Est. completion date: December 2010

Study information

• Verified date: March 2010
• Source: Kowloon Hospital, Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: HongKong, China: Research Ethics Committee (Kowloon Central / Kowloon East)
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Rehabilitation
• Stroke

Intervention

Other:
• Patient Engagement Programme
Patient's Diary, Ad Hoc medical support and Ad Hoc Clinical admission, Early post discharge Home visit

Locations

Country	Name	City	State
China	Department of Rehabilitation, Kowloon Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Kowloon Hospital, Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unplanned Medical readmissions		3 months	No
Primary	Length of hospital stay		3 months	No
Primary	Emergency Department attendance rate		3 months	No
Secondary	Carer and Patient Satisfactory Survey		3 months	No
Secondary	Carer Strain Index		3months	No
Secondary	Medical complications		3 months	No
Secondary	Functional Independence Measure		3 months	No
Secondary	Barthel Index		3 months	No
Secondary	Modified Rivermead Mobility Index		3 months	No
Secondary	Modified Ashworth Score		3 months	No
Secondary	Geriatric Geriatric Depression Scale		3 months	No