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My Stroke Team (MYST): Stroke App Pilot Study

Primary Purpose

Stroke, Comorbidity, Chronic Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Strengthening Community-Based Stroke Care: A Pilot Study of a Community Navigation and Rehabilitation Intervention that Includes a Mobile Health Solution
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke focused on measuring Mobile health technology, Multiple chronic conditions, Older adults, Home and community care, Effectiveness, Cost analysis, Interprofessional Stroke Rehabilitation

Eligibility Criteria

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

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.

Sites / Locations

  • Hamilton Health Sciences

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

The intervention cohort.

Arm Description

A community transition and rehabilitation intervention that includes a mobile health solution

Outcomes

Primary Outcome Measures

Changes in health-related quality of life (HRQoL) for both stroke survivors and caregivers as measured by the SF-12
The Short-Form 12(SF-12) Health Survey will be administered to stroke survivors and caregivers to measure health-related quality of life
Feasibility of the mobile application as part of the intervention.
Participants' perspectives on the feasibility of the mobile application will be assessed qualitatively through focus groups (HCPs) and interviews (stroke survivors and family caregivers).

Secondary Outcome Measures

Changes in the degree of physical functioning related to stroke.
The Stroke Impact Scale (SIS)-16 will be administered to stroke survivors at baseline and 6 months, to assess physical functioning related to stroke
Change in the prevalence and severity of depression symptoms in stroke survivors and family caregivers.
The Centre for Epidemiological Studies Depression Scale (CES-D-10) will be used to assess the prevalence and the severity of depression symptoms.
Change in the degree of strain of family caregiver.
The Modified Caregiver Strain Index(CSI) will be administered to every stroke survivor's family caregiver at baseline and at 6 months to assess change in burden associated with caregiving
Change in prevalence and severity of anxiety.
The Generalized Anxiety Disorder Screener-7 (GAD-7) scale will be used to assess changes in the degree of anxiety of stroke survivors at baseline and 6 months from baseline.
Change in the self efficacy of stroke survivors.
The Stanford's 6-item Self-Efficacy for Managing Chronic Disease Scale (SE-MCD) will be administered to stroke survivors to assess changes in self efficacy at baseline and end of the study.
Change in the community integration of stroke patients.
The Reintegration to Normal Living Index (RNLI) will be administered to stroke survivors to assess degree of community reintegration post-stroke.
Change in the costs of use of health services by stroke survivors and family caregivers
The costs of use of all types of health services from baseline to six months will be determined using the Health and Social Services Utilization Inventory (HSSUI).
Change in team functioning.
The Collaborative Practice Assessment Tool will be administered to home care providers to assess changes in team functioning.
Change in level of integration between home care providers.
The Team Climate Inventory will be administered to home care providers to assess changes in their level of integration.

Full Information

First Posted
August 28, 2014
Last Updated
March 5, 2019
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT02230280
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 8, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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? 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)? 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? 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? 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Comorbidity, Chronic Disease
Keywords
Mobile health technology, Multiple chronic conditions, Older adults, Home and community care, Effectiveness, Cost analysis, Interprofessional Stroke Rehabilitation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The intervention cohort.
Arm Type
Other
Arm Description
A community transition and rehabilitation intervention that includes a mobile health solution
Intervention Type
Other
Intervention Name(s)
Strengthening Community-Based Stroke Care: A Pilot Study of a Community Navigation and Rehabilitation Intervention that Includes a Mobile Health Solution
Intervention Description
Participants will be offered regular in-home visits over the 6-month study period in addition to usual outpatient rehabilitation services. The health care providers will have access to a mobile health application (MYST) to share real-time information and access community resources and best practice guidelines.
Primary Outcome Measure Information:
Title
Changes in health-related quality of life (HRQoL) for both stroke survivors and caregivers as measured by the SF-12
Description
The Short-Form 12(SF-12) Health Survey will be administered to stroke survivors and caregivers to measure health-related quality of life
Time Frame
Baseline and the end of the intervention (6 months from baseline)
Title
Feasibility of the mobile application as part of the intervention.
Description
Participants' perspectives on the feasibility of the mobile application will be assessed qualitatively through focus groups (HCPs) and interviews (stroke survivors and family caregivers).
Time Frame
At the end of the intervention (6 months)
Secondary Outcome Measure Information:
Title
Changes in the degree of physical functioning related to stroke.
Description
The Stroke Impact Scale (SIS)-16 will be administered to stroke survivors at baseline and 6 months, to assess physical functioning related to stroke
Time Frame
Baseline and the end of the intervention (6 months from baseline)
Title
Change in the prevalence and severity of depression symptoms in stroke survivors and family caregivers.
Description
The Centre for Epidemiological Studies Depression Scale (CES-D-10) will be used to assess the prevalence and the severity of depression symptoms.
Time Frame
Baseline and the end of the intervention (6 months from baseline)
Title
Change in the degree of strain of family caregiver.
Description
The Modified Caregiver Strain Index(CSI) will be administered to every stroke survivor's family caregiver at baseline and at 6 months to assess change in burden associated with caregiving
Time Frame
Baseline and the end of the intervention (6months from baseline)
Title
Change in prevalence and severity of anxiety.
Description
The Generalized Anxiety Disorder Screener-7 (GAD-7) scale will be used to assess changes in the degree of anxiety of stroke survivors at baseline and 6 months from baseline.
Time Frame
Baseline and end of intervention (6 months from baseline)
Title
Change in the self efficacy of stroke survivors.
Description
The Stanford's 6-item Self-Efficacy for Managing Chronic Disease Scale (SE-MCD) will be administered to stroke survivors to assess changes in self efficacy at baseline and end of the study.
Time Frame
Baseline and end of the intervention (6 months from baseline)
Title
Change in the community integration of stroke patients.
Description
The Reintegration to Normal Living Index (RNLI) will be administered to stroke survivors to assess degree of community reintegration post-stroke.
Time Frame
Baseline and end of the intervention (6 months from baseline)
Title
Change in the costs of use of health services by stroke survivors and family caregivers
Description
The costs of use of all types of health services from baseline to six months will be determined using the Health and Social Services Utilization Inventory (HSSUI).
Time Frame
Baseline and end of intervention (6 months from baseline)
Title
Change in team functioning.
Description
The Collaborative Practice Assessment Tool will be administered to home care providers to assess changes in team functioning.
Time Frame
At three months into the intervention study and upon completion of the study (16 months)
Title
Change in level of integration between home care providers.
Description
The Team Climate Inventory will be administered to home care providers to assess changes in their level of integration.
Time Frame
At three months into the intervention study and upon completion of the study (16 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maureen Markle-Reid, RN, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4L8
Country
Canada

12. IPD Sharing Statement

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My Stroke Team (MYST): Stroke App Pilot Study

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