Clinical trial NCT01112488: Patient Engagement Program for Stroke - Pilot Study
Official title: Patient Engagement Program for Stroke - Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Rehabilitation
Keywords: stroke
patient engagement programme
community rehabilitation
new carer
Lead sponsor: Kowloon Hospital, Hong Kong
Sponsor class: OTHER
First posted: 2010-04-28
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Unplanned Medical readmissions
timeFrame: 3 months
measure: Length of hospital stay
timeFrame: 3 months
measure: Emergency Department attendance rate
timeFrame: 3 months
Secondary outcomes:
measure: Carer and Patient Satisfactory Survey
timeFrame: 3 months
measure: Carer Strain Index
timeFrame: 3months
measure: Medical complications
timeFrame: 3 months
measure: Functional Independence Measure
timeFrame: 3 months
measure: Barthel Index
timeFrame: 3 months
measure: Modified Rivermead Mobility Index
timeFrame: 3 months
measure: Modified Ashworth Score
timeFrame: 3 months
measure: Geriatric Geriatric Depression Scale
timeFrame: 3 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Rehabilitation, Kowloon Hospital
Study officials:
affiliation: Department of Rehabilitaiton, Kowloon Hospital
name: Mandy PM Fung, FHKCP
role: PRINCIPAL_INVESTIGATOR
References: