Early Supported Discharge After Stroke in Bergen
1 other identifier
interventional
306
1 country
1
Brief Summary
The main purpose of this study is to evaluate the benefit of early supported discharge (ESD) in rehabilitation of stroke patients in two different outpatient modalities. In a collaborating study, changes in physical function as well as the patients' own perception of physical function, pain and fatigue will be studied. In further collaborating studies, health economics and organizational issues will also be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Dec 2008
Longer than P75 for not_applicable stroke
1 active site
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
October 10, 2008
CompletedFirst Posted
Study publicly available on registry
October 13, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFebruary 25, 2014
February 1, 2014
3.5 years
October 10, 2008
February 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MRS
Modified Rankin Scale
6 months
Secondary Outcomes (14)
NIHSS
3, 6 and 12 months
BI
3, 6, 12 and 24 months
AMPS
3 and 6 months
TIS
3 and 6 months
SIS
12 months
- +9 more secondary outcomes
Study Arms (3)
Day unit rehabilitation
ACTIVE COMPARATORDischarge from the hospital to the patients' homes as soon as possible, supported by an out-patient ambulatory coordinating multidisciplinary team. The patients will be offered rehabilitation in a day unit, and multidisciplinary policlinical follow-ups will be performed 3 and 6 months after inclusion.
Home rehabilitation
ACTIVE COMPARATORDischarge from the hospital to the patients' homes as soon as possible, supported by an out-patient ambulatory coordinating multidisciplinary team. The patients will be offered rehabilitation treatment in their homes, and multidisciplinary policlinical follow-ups will be performed 3 and 6 months after inclusion.
Treatment as usual
NO INTERVENTIONPatients will receive rehabilitation treatment after today's principles and routines.
Interventions
Treatment by physiotherapist and occupational therapist up to 4 hours a day for up to 5 weeks in a day unit
Treatment by physiotherapist and occupational therapist up to 4 hours a day for up to 5 weeks in the patient's home
Eligibility Criteria
You may qualify if:
- Living in own home in the community of Bergen, Norway
- The patient must be awake and informed consent must be given by patient or relatives
You may not qualify if:
- Serious psychic illness
- Serious drug abuse
- Serious medical conditions that can influence the patients' cerebrovascular disease or rehabilitation
- Poor knowledge of the Norwegian language
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Haukeland University Hospitallead
- University of Bergencollaborator
- Municipality of Bergen, Norwaycollaborator
- Kavli Research Centre for Ageing and Dementiacollaborator
Study Sites (1)
Haukeland University Hospital
Bergen, N-5021, Norway
Related Publications (4)
Hofstad H, Naess H, Moe-Nilssen R, Skouen JS. Early supported discharge after stroke in Bergen (ESD Stroke Bergen): a randomized controlled trial comparing rehabilitation in a day unit or in the patients' homes with conventional treatment. Int J Stroke. 2013 Oct;8(7):582-7. doi: 10.1111/j.1747-4949.2012.00825.x. Epub 2012 May 18.
PMID: 22594689BACKGROUNDGjelsvik B, Breivik K, Verheyden G, Smedal T, Hofstad H, Strand LI. The Trunk Impairment Scale - modified to ordinal scales in the Norwegian version. Disabil Rehabil. 2012;34(16):1385-95. doi: 10.3109/09638288.2011.645113. Epub 2011 Dec 23.
PMID: 22191850RESULTHofstad H, Gjelsvik BE, Naess H, Eide GE, Skouen JS. Early supported discharge after stroke in Bergen (ESD Stroke Bergen): three and six months results of a randomised controlled trial comparing two early supported discharge schemes with treatment as usual. BMC Neurol. 2014 Dec 21;14:239. doi: 10.1186/s12883-014-0239-3.
PMID: 25528166DERIVEDGjelsvik BE, Hofstad H, Smedal T, Eide GE, Naess H, Skouen JS, Frisk B, Daltveit S, Strand LI. Balance and walking after three different models of stroke rehabilitation: early supported discharge in a day unit or at home, and traditional treatment (control). BMJ Open. 2014 May 14;4(5):e004358. doi: 10.1136/bmjopen-2013-004358.
PMID: 24833680DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jan S. Skouen, PhD
Haukeland University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2008
First Posted
October 13, 2008
Study Start
December 1, 2008
Primary Completion
June 1, 2012
Study Completion
December 1, 2013
Last Updated
February 25, 2014
Record last verified: 2014-02