Clinical trial NCT00495248: Thriving, Activity and Social Participation After Stroke
Official title: Well-being, Activity and Social Participation After Stroke/TIA. RCT-psycho Social Intervention Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Stroke
Keywords: group intervention
stroke
senior centres
health promotion
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: The Royal Norwegian Ministry of Health
name: The Norwegian Women´s Public Health Association
First posted: 2007-07-03
Enrollment: 140
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Stroke is a common disease among older people. In Norway 60-70 000 people live with sequela after stroke. Depressive symptoms, anxiety and social isolation are occurring among 20 to 60 percent. Little is known about intervention for people with mild neurological symptoms who simultaneously perceive social isolation, depression and reduced satisfaction in their daily life after stroke. Lifestyle redesign (LR) is developed in the USA and is a health promoting group intervention programme with focus on the participants' exchange of experiences and involvement. The aim of the study is to evaluate the effect on thriving, activity and social participation of a group intervention program inspired by Lifestyle redesign for community dwelling persons with stroke. The study is conducted as a multicentre randomized controlled trial. Participants are recruited from five hospitals and the intervention is carried through at six to seven senior centres. The control group is offered a physical activity programme at the senior centre once a week. The intervention group is offered the same with the additional intervention programme also once a week. The study will contribute to knowledge whether this group 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* reduced consent
* severe disease
* clinical contradictions evaluated by the responsible physician

Primary outcomes:
measure: SF-36
timeFrame: Approximately 3 months after stroke-BASELINE, after 6 and 9 months
Secondary outcomes:
measure: Hospital Anxiety Depression Scale (HAD), Canadian Occupational Performance Measure (COPM), Trail making A and B, Timed up and go (TUG)
timeFrame: Approximately 3 months after stroke-BASELINE, after 6 and 9 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Ullevaal University Hospital, Department of Geriatric Medicine, Research Unit
Study officials:
affiliation: Ullevaal University Hospital ,Medical division, research Unit 0407 Oslo Norway
name: Unni Sveen, PhD
role: STUDY_DIRECTOR
References: