Thriving, Activity and Social Participation After Stroke

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Oslo University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
The Royal Norwegian Ministry of Health
The Norwegian Women´s Public Health Association
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00495248
First received: July 2, 2007
Last updated: August 8, 2011
Last verified: August 2011

July 2, 2007
August 8, 2011
January 2007
September 2009   (final data collection date for primary outcome measure)
SF-36 [ Time Frame: Approximately 3 months after stroke-BASELINE, after 6 and 9 months ] [ Designated as safety issue: No ]
SF-36 [ Time Frame: Approximately 3 months after stroke-BASELINE, after 6 and 9 months ]
Complete list of historical versions of study NCT00495248 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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 ]
Not Provided
Not Provided
 
Thriving, Activity and Social Participation After Stroke
Well-being, Activity and Social Participation After Stroke/TIA. RCT-psycho Social Intervention Study.

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Stroke
  • Behavioral: Group intervention inspired by Lifestyle Redesign
    Group intervention inspired by Lifestyle Redesign
    Other Name: Lifestyle councelling
  • Behavioral: Group intervention inspired by Lifestyle redesign
    Lifestyle programme once a week for two hours over an intervention period of 9 months
  • Experimental: 1
    Interventions:
    • Behavioral: Group intervention inspired by Lifestyle Redesign
    • Behavioral: Group intervention inspired by Lifestyle redesign
  • Active Comparator: 2
    Intervention: Behavioral: Group intervention inspired by Lifestyle Redesign
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
140
September 2011
September 2009   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00495248
UUS838
No
Unni Sveen - PhD, Ullevaal University Hospital, Department of Geriatric Medicine
Ullevaal University Hospital
  • The Royal Norwegian Ministry of Health
  • The Norwegian Women´s Public Health Association
Study Director: Unni Sveen, PhD Ullevaal University Hospital ,Medical division, research Unit 0407 Oslo Norway
Oslo University Hospital
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP