NCT01112488

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started May 2010

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 28, 2010

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 28, 2010

Status Verified

March 1, 2010

Enrollment Period

7 months

First QC Date

April 22, 2010

Last Update Submit

April 27, 2010

Conditions

Keywords

strokepatient engagement programmecommunity rehabilitationnew carer

Outcome Measures

Primary Outcomes (3)

  • Unplanned Medical readmissions

    3 months

  • Length of hospital stay

    3 months

  • Emergency Department attendance rate

    3 months

Secondary Outcomes (8)

  • Carer and Patient Satisfactory Survey

    3 months

  • Carer Strain Index

    3months

  • Medical complications

    3 months

  • Functional Independence Measure

    3 months

  • Barthel Index

    3 months

  • +3 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

usual care

multidisciplinary intervention

EXPERIMENTAL

Patient engagement Programme

Other: Patient Engagement Programme

Interventions

Patient's Diary, Ad Hoc medical support and Ad Hoc Clinical admission, Early post discharge Home visit

multidisciplinary intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • A stroke patient being discharged from a rehabilitation unit planned to be discharged to community with new carer

You may not qualify if:

  • plan to enter institution within 3 months of discharge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation, Kowloon Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Mandy PM Fung, FHKCP

    Department of Rehabilitaiton, Kowloon Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 22, 2010

First Posted

April 28, 2010

Study Start

May 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

April 28, 2010

Record last verified: 2010-03

Locations