Thriving, Activity and Social Participation After Stroke

Stroke Clinical Trial

Official title:

Well-being, Activity and Social Participation After Stroke/TIA. RCT-psycho Social Intervention Study.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00495248
• Other study ID #: UUS838
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: July 2, 2007
• Last updated: August 8, 2011
• Start date: January 2007
• Est. completion date: September 2011

Study information

• Verified date: August 2011
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: September 2011
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Group intervention inspired by Lifestyle Redesign
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

Locations

Country	Name	City	State
Norway	Ullevaal University Hospital, Department of Geriatric Medicine, Research Unit	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Ullevaal University Hospital	The Norwegian Women´s Public Health Association, The Royal Norwegian Ministry of Health

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SF-36		Approximately 3 months after stroke-BASELINE, after 6 and 9 months	No
Secondary	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	No