Thriving, Activity and Social Participation After Stroke
Well-being, Activity and Social Participation After Stroke/TIA. RCT-psycho Social Intervention Study.
1 other identifier
interventional
140
1 country
1
Brief Summary
The aim of the study is to evaluate the effect of a group intervention programme for community dwelling elders with stroke or TIA.The intervention is inspired by a Lifestyle Redesign method developed in the USA. The study is conducted as a multi centre randomized controlled trial. Participants are recruited from five hospitals and the intervention is implemented at six to seven senior centres. The control group is offered physical activity at the senior centre once a week. The intervention group is offered the same with addition of the programme inspired by Lifestyle Redesign. The study will contribute to knowledge whether the intervention will promote social participation and thriving in daily life and prevent social isolation and depressive symptoms among community dwelling elders with stroke or TIA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 stroke
Started Jan 2007
Longer than P75 for phase_1 stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 2, 2007
CompletedFirst Posted
Study publicly available on registry
July 3, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedAugust 9, 2011
August 1, 2011
2.7 years
July 2, 2007
August 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SF-36
Approximately 3 months after stroke-BASELINE, after 6 and 9 months
Secondary Outcomes (1)
Hospital Anxiety Depression Scale (HAD), Canadian Occupational Performance Measure (COPM), Trail making A and B, Timed up and go (TUG)
Approximately 3 months after stroke-BASELINE, after 6 and 9 months
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Group intervention inspired by Lifestyle Redesign
Eligibility Criteria
You may qualify if:
- oral and written consent
- age 65+
- clinical stroke ref WHO definition
- home-dwelling previous to stroke
- home-service less than twice a week previous to stroke
- Barthel ADL-index \>14 of 20
- MMS \>23 of 30
- be able to communicate evaluated by Ulleval aphasia screening test
You may not qualify if:
- reduced consent
- severe disease
- clinical contradictions evaluated by the responsible physician
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ullevaal University Hospital, Department of Geriatric Medicine, Research Unit
Oslo, Oslo County, 0407, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Unni Sveen, PhD
Ullevaal University Hospital ,Medical division, research Unit 0407 Oslo Norway
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 2, 2007
First Posted
July 3, 2007
Study Start
January 1, 2007
Primary Completion
September 1, 2009
Study Completion
September 1, 2011
Last Updated
August 9, 2011
Record last verified: 2011-08