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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02230280
Date of registration: 28/08/2014
Prospective Registration: Yes
Primary sponsor: McMaster University
Public title: My Stroke Team (MYST): Stroke App Pilot Study
Scientific title: Strengthening Community-Based Stroke Care: A Pilot Study of a Community Navigation and Rehabilitation Intervention That Includes a Mobile Health Solution
Date of first enrolment: May 8, 2017
Target sample size: 30
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02230280
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Canada
Contacts
Name:     Maureen Markle-Reid, RN, PhD
Address: 
Telephone:
Email:
Affiliation:  McMaster University
Key inclusion & exclusion criteria

Inclusion Criteria:

- Participants are newly referred for outpatient rehabilitation with a confirmed
diagnosis of stroke (first ever or recurrent) within the past 12 months, and are not
planning to move away from the community in the next 6 months. Participants have at
least 2 predetermined comorbid conditions, and must have the capacity to provide
informed consent, either independently or by substitute decision maker.

Exclusion Criteria:

- Participants will be excluded if they are unable to read and understand English and do
not have access to a translator.



Age minimum: 55 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Stroke
Chronic Disease
Comorbidity
Intervention(s)
Other: Strengthening Community-Based Stroke Care: A Pilot Study of a Community Navigation and Rehabilitation Intervention that Includes a Mobile Health Solution
Primary Outcome(s)
Feasibility of the mobile application as part of the intervention. [Time Frame: At the end of the intervention (6 months)]
Changes in health-related quality of life (HRQoL) for both stroke survivors and caregivers as measured by the SF-12 [Time Frame: Baseline and the end of the intervention (6 months from baseline)]
Secondary Outcome(s)
Change in the community integration of stroke patients. [Time Frame: Baseline and end of the intervention (6 months from baseline)]
Change in prevalence and severity of anxiety. [Time Frame: Baseline and end of intervention (6 months from baseline)]
Change in team functioning. [Time Frame: At three months into the intervention study and upon completion of the study (16 months)]
Changes in the degree of physical functioning related to stroke. [Time Frame: Baseline and the end of the intervention (6 months from baseline)]
Change in the self efficacy of stroke survivors. [Time Frame: Baseline and end of the intervention (6 months from baseline)]
Change in level of integration between home care providers. [Time Frame: At three months into the intervention study and upon completion of the study (16 months)]
Change in the costs of use of health services by stroke survivors and family caregivers [Time Frame: Baseline and end of intervention (6 months from baseline)]
Change in the prevalence and severity of depression symptoms in stroke survivors and family caregivers. [Time Frame: Baseline and the end of the intervention (6 months from baseline)]
Change in the degree of strain of family caregiver. [Time Frame: Baseline and the end of the intervention (6months from baseline)]
Secondary ID(s)
STPILOT-134162
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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