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Thriving, Activity and Social Participation After Stroke

Primary Purpose

Stroke

Status
Unknown status
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
Group intervention inspired by Lifestyle Redesign
Group intervention inspired by Lifestyle redesign
Sponsored by
Ullevaal University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring group intervention, stroke, senior centres, health promotion

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ullevaal University Hospital, Department of Geriatric Medicine, Research Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

SF-36

Secondary Outcome Measures

Hospital Anxiety Depression Scale (HAD), Canadian Occupational Performance Measure (COPM), Trail making A and B, Timed up and go (TUG)

Full Information

First Posted
July 2, 2007
Last Updated
August 8, 2011
Sponsor
Ullevaal University Hospital
Collaborators
The Royal Norwegian Ministry of Health, The Norwegian Women´s Public Health Association
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1. Study Identification

Unique Protocol Identification Number
NCT00495248
Brief Title
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

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Ullevaal University Hospital
Collaborators
The Royal Norwegian Ministry of Health, The Norwegian Women´s Public Health Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
group intervention, stroke, senior centres, health promotion

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Group intervention inspired by Lifestyle Redesign
Other Intervention Name(s)
Lifestyle councelling
Intervention Description
Group intervention inspired by Lifestyle Redesign
Intervention Type
Behavioral
Intervention Name(s)
Group intervention inspired by Lifestyle redesign
Intervention Description
Lifestyle programme once a week for two hours over an intervention period of 9 months
Primary Outcome Measure Information:
Title
SF-36
Time Frame
Approximately 3 months after stroke-BASELINE, after 6 and 9 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Unni Sveen, PhD
Organizational Affiliation
Ullevaal University Hospital ,Medical division, research Unit 0407 Oslo Norway
Official's Role
Study Director
Facility Information:
Facility Name
Ullevaal University Hospital, Department of Geriatric Medicine, Research Unit
City
Oslo
ZIP/Postal Code
0407
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

Thriving, Activity and Social Participation After Stroke

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