Getting on With the Rest of Your Life After a Stroke

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Canadian Stroke Network
Information provided by (Responsible Party):
Nancy Mayo, McGill University
ClinicalTrials.gov Identifier:
NCT01085240
First received: March 10, 2010
Last updated: April 26, 2013
Last verified: April 2013

March 10, 2010
April 26, 2013
September 2008
September 2013   (final data collection date for primary outcome measure)
Participation [ Time Frame: baseline, 3, 6, 12 and 15 months ] [ Designated as safety issue: No ]
participation in leisure measured using the CHAMPS
Same as current
Complete list of historical versions of study NCT01085240 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Getting on With the Rest of Your Life After a Stroke
Getting on With the Rest of Your Life After Stroke: A Cross-Canada Program Aimed at Enhanced Life Participation, Prevention of Deterioration and Optimization of Health Care Utilization

The primary objective is to determine the extent to which participation in life's roles can be optimized through the provision of a community-based structured program providing the opportunity for physical activity, leisure, and social interaction.

A secondary objective is to estimate the extent to which participation is associated with health benefits including health-related quality of life and reduction of unplanned health-care encounters for the person with stroke and reduction of burden and improvement in quality of life for caregivers.

In the fall of 2004, a group of rehabilitation researchers developed a protocol for a cross-Canada randomized trial aimed at enhancing life participation after stroke. This project was an important part of the CSN's program and its renewal submission to the Networks of Centers of Excellence. In December 2004 the Canadian Stroke Network agreed to fund pilot work for this ambitious project, spread over six sites. The pilot funding permitted key aspects of the protocol to be developed and put in place: (i) elements of the intervention have been chosen (physical activity, leisure and social) (ii) the assessment tools have been chosen and tested; (iii) community-based partner organizations have been identified; and (iv) the intervention prototype has been tested for feasibility.

The primary objective of the main trial is to determine the extent to which participation in life's roles can be optimized through the provision of a community-based structured program providing the opportunity for physical activity, leisure, and social interaction. A secondary objective is to estimate the extent to which participation is associated with health benefits including health-related quality of life and reduction of unplanned health-care encounters for the person with stroke and reduction of burden and improvement in quality of life for caregivers. In this context, the meaning of "participation" is as defined by the World' Health Organization (WHO) and reflects both society's and the person's perspective.

The target population will be persons living in the community who have completed all formal institution-based, in-patient and ambulatory, rehabilitative interventions. No restriction on time since stroke will be imposed. Excluded will be persons who are already enrolled in existing community based projects and persons with cognitive impairment.

Sites: Six sites participated in the feasibility phase. Information emanating from these sites as well as dissemination activities of the CSN and the Canadian Stroke Strategy, have led to interest expressed by other sites across Canada prepared to run the trial phase of this project.

The study design proposed is a two-period, site-stratified, randomized, crossover design with timing of entry randomized to immediate entry or delayed entry so that there is about a six month time difference between groups. The intervention period is 9 months and the follow-up period is an additional 6 months (total 15 mos.) This design would provide for both assessment of between- group and within-person change. The main outcome is the amount of time spent in meaningful activity during the day (outcome related to primary objective).

Sample size required to have sufficient power to detect between-group differences is 240 subjects from sites across Canada. As there is considerable interest in community reintegration, "snowball" entry of sites would make it more realistic to accumulate sample size and would also make the results more generalizable and locally responsive.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Stroke
Other: Mission Possible
The intervention focuses on leisure education, exercise and community re-integration.
Other Names:
  • Mission Possible
  • Participation
  • Start Later
    The participants receive the Mission Possible intervention but it is delayed by 3 months.
    Intervention: Other: Mission Possible
  • Experimental: Start Now
    The participants start the Mission Possible program right away.
    Intervention: Other: Mission Possible
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
240
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • living in the community
  • who have completed all formal institution-based, in-patient and ambulatory, rehabilitative interventions.

Exclusion Criteria:

  • already enrolled in existing community based projects
  • persons with cognitive impairment
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01085240
A12-B44-06A
No
Nancy Mayo, McGill University
McGill University
Canadian Stroke Network
Principal Investigator: Nancy E Mayo, PhD Division of Clinical Epidemiology
McGill University
April 2013

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