Clinical trial NCT02230280: My Stroke Team (MYST): Stroke App Pilot Study
Official title: Strengthening Community-Based Stroke Care: A Pilot Study of a Community Navigation and Rehabilitation Intervention That Includes a Mobile Health Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Comorbidity
Chronic Disease
Keywords: Mobile health technology
Multiple chronic conditions
Older adults
Home and community care
Effectiveness
Cost analysis
Interprofessional Stroke Rehabilitation
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2014-09-03
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Most stroke survivors live with other chronic health conditions that can negatively affect their recovery and overall health and well-being. Although stroke care has improved, there are still many challenges to the delivery of community-based stroke care. These challenges include: poor coordination of care across health care providers and settings; limited communication among health care providers; limited use of evidence-based treatment guidelines; difficulties navigating community services and supports; and limited client and family caregiver involvement in making healthcare decisions. The investigators developed a new mobile health (mHealth) application, My Stroke Team (MYST), to address these challenges to improve the overall quality of stroke care at home. This study will expand this work to: 1) explore the feasibility and acceptability of this mobile tool, 2) determine its impact and usability for home care providers, stroke survivors, and their family caregivers, and 3) determine its impact on the costs of use of health services.

Detailed description: Research Questions:

1. What is the feasibility and acceptability of the MYST app within the context of a 6-month community navigation and rehabilitation intervention from the perspectives of health care providers, clients, and family caregivers?
2. What are the MYST app usage patterns by various subgroups of end-users (e.g., clients, health-care providers, age groups of HCPs, stroke survivors and family caregivers)?
3. What is the effect of the intervention on stroke survivors' health-related quality of life, community re-integration, physical functioning, depression, anxiety, self-efficacy, and costs of use of health services, from a societal perspective?
4. What is the effect of the intervention on family caregivers' health-related quality of life, caregiver strain, depression, anxiety, and costs of use of health services from a societal perspective?
5. What is the effect of the intervention on HCP outcomes (interprofessional collaboration)?

Methods:

Due to the complexity of evaluating health services interventions, a mixed methods design will be used to evaluate the multi-component intervention. A pragmatic pre-test post-test single site study design will be used to evaluate the intervention. By pragmatic, the investigators mean the intervention will be implemented under real-world conditions, including reliance on existing staff at the participating site. Assessments will be made at baseline (pre-test) and immediately following the six-month intervention period (post-test). Descriptive qualitative methods will be used to explore the feasibility and acceptability of the intervention.

Outcomes will be assessed at baseline and 6 months. Summary descriptive measures will be reported for all variables.

Expected Outcomes:

It is expected that stroke survivors with multiple chronic conditions, their family caregivers and healthcare providers will find the MYST app acceptable and feasible.

Eligibility 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.

Primary outcomes:
measure: Changes in health-related quality of life (HRQoL) for both stroke survivors and caregivers as measured by the SF-12
timeFrame: Baseline and the end of the intervention (6 months from baseline)
measure: Feasibility of the mobile application as part of the intervention.
timeFrame: At the end of the intervention (6 months)
Secondary outcomes:
measure: Changes in the degree of physical functioning related to stroke.
timeFrame: Baseline and the end of the intervention (6 months from baseline)
measure: Change in the prevalence and severity of depression symptoms in stroke survivors and family caregivers.
timeFrame: Baseline and the end of the intervention (6 months from baseline)
measure: Change in the degree of strain of family caregiver.
timeFrame: Baseline and the end of the intervention (6months from baseline)
measure: Change in prevalence and severity of anxiety.
timeFrame: Baseline and end of intervention (6 months from baseline)
measure: Change in the self efficacy of stroke survivors.
timeFrame: Baseline and end of the intervention (6 months from baseline)
measure: Change in the community integration of stroke patients.
timeFrame: Baseline and end of the intervention (6 months from baseline)
measure: Change in the costs of use of health services by stroke survivors and family caregivers
timeFrame: Baseline and end of intervention (6 months from baseline)
measure: Change in team functioning.
timeFrame: At three months into the intervention study and upon completion of the study (16 months)
measure: Change in level of integration between home care providers.
timeFrame: At three months into the intervention study and upon completion of the study (16 months)
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: McMaster University
name: Maureen Markle-Reid, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: