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
  Purpose

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.


Condition Intervention Phase
Stroke
Behavioral: Group intervention inspired by Lifestyle Redesign
Behavioral: Group intervention inspired by Lifestyle redesign
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Well-being, Activity and Social Participation After Stroke/TIA. RCT-psycho Social Intervention Study.

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • SF-36 [ Time Frame: Approximately 3 months after stroke-BASELINE, after 6 and 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 140
Study Start Date: January 2007
Estimated Study Completion Date: September 2011
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
Active Comparator: 2 Behavioral: Group intervention inspired by Lifestyle Redesign
Group intervention inspired by Lifestyle Redesign
Other Name: Lifestyle councelling

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495248

Locations
Norway
Ullevaal University Hospital, Department of Geriatric Medicine, Research Unit
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
The Royal Norwegian Ministry of Health
The Norwegian Women´s Public Health Association
Investigators
Study Director: Unni Sveen, PhD Ullevaal University Hospital ,Medical division, research Unit 0407 Oslo Norway
  More Information

No publications provided

Responsible Party: Unni Sveen - PhD, Ullevaal University Hospital, Department of Geriatric Medicine
ClinicalTrials.gov Identifier: NCT00495248     History of Changes
Other Study ID Numbers: UUS838
Study First Received: July 2, 2007
Last Updated: August 8, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
group intervention
stroke
senior centres
health promotion

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 24, 2014