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
  Purpose

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.


Condition Intervention Phase
Stroke
Other: Mission Possible
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by McGill University:

Primary Outcome Measures:
  • Participation [ Time Frame: baseline, 3, 6, 12 and 15 months ] [ Designated as safety issue: No ]
    participation in leisure measured using the CHAMPS


Estimated Enrollment: 240
Study Start Date: September 2008
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Start Later
The participants receive the Mission Possible intervention but it is delayed by 3 months.
Other: Mission Possible
The intervention focuses on leisure education, exercise and community re-integration.
Other Names:
  • Mission Possible
  • Participation
Experimental: Start Now
The participants start the Mission Possible program right away.
Other: Mission Possible
The intervention focuses on leisure education, exercise and community re-integration.
Other Names:
  • Mission Possible
  • Participation

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01085240

Locations
Canada, Quebec
Division fo Clinical epidemiology
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
McGill University
Canadian Stroke Network
Investigators
Principal Investigator: Nancy E Mayo, PhD Division of Clinical Epidemiology
  More Information

No publications provided

Responsible Party: Nancy Mayo, PhD, McGill University
ClinicalTrials.gov Identifier: NCT01085240     History of Changes
Other Study ID Numbers: A12-B44-06A
Study First Received: March 10, 2010
Last Updated: April 26, 2013
Health Authority: Canada: Ethics Review Committee

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 April 17, 2014