Overview

This trial is active, not recruiting.

Condition stroke
Treatments group intervention inspired by lifestyle redesign
Phase phase 1/phase 2
Sponsor Ullevaal University Hospital
Collaborator The Royal Norwegian Ministry of Health
Start date January 2007
End date September 2009
Trial size 140 participants
Trial identifier NCT00495248, UUS838

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
group intervention inspired by lifestyle redesign Lifestyle councelling
Group intervention inspired by Lifestyle Redesign
group intervention inspired by lifestyle redesign
Lifestyle programme once a week for two hours over an intervention period of 9 months
(Active Comparator)
group intervention inspired by lifestyle redesign Lifestyle councelling
Group intervention inspired by Lifestyle Redesign

Primary Outcomes

Measure
SF-36
time frame: 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)
time frame: Approximately 3 months after stroke-BASELINE, after 6 and 9 months

Eligibility Criteria

Male or female participants at least 65 years old.

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

Additional Information

Official title Well-being, Activity and Social Participation After Stroke/TIA. RCT-psycho Social Intervention Study.
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2011.
Information provided to ClinicalTrials.gov by Oslo University Hospital.