StrokeNCT02230280
My Stroke Team (MYST): Stroke App Pilot Study
A study testing Strengthening Community-Based Stroke Care: A Pilot Study of a Community Navigation and Rehabilitation Intervention that Includes a Mobile Health Solution in people with Stroke and Comorbidity, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Stroke, Comorbidity, Chronic Disease
- What is being tested?
- Strengthening Community-Based Stroke Care: A Pilot Study of a Community Navigation and Rehabilitation Intervention that Includes a Mobile Health Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 8 May 2017to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants will be excluded if they are unable to read and understand English and do not have access to a translator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strengthening Community-Based Stroke Care: A Pilot Study of a Community Navigation and Rehabilitation Intervention That Includes a Mobile Health Solution
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.
Read the 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.
- Conditions
- Stroke, Comorbidity, Chronic Disease
- Being tested
- Strengthening Community-Based Stroke Care: A Pilot Study of a Community Navigation and Rehabilitation Intervention that Includes a Mobile Health Solution
- Keywords
- Mobile health technology, Multiple chronic conditions, Older adults, Home and community care, Effectiveness, Cost analysis, Interprofessional Stroke Rehabilitation
- Medical subject headings
- Stroke, Chronic Disease, Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strengthening Community-Based Stroke Care: A Pilot Study of a Community Navigation and Rehabilitation Intervention that Includes a Mobile Health SolutionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| The intervention cohort. | Other | A community transition and rehabilitation intervention that includes a mobile health solution Receives: Other: Strengthening Community-Based Stroke Care: A Pilot Study of a Community Navigation and Rehabilitation Intervention that Includes a Mobile Health Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and the end of the intervention (6 months from baseline)
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).
Measured: At the end of the intervention (6 months)
Secondary outcomes (9)
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
Measured: Baseline and the end of the intervention (6 months from baseline)
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.
Measured: Baseline and the end of the intervention (6 months from baseline)
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
Measured: Baseline and the end of the intervention (6months from baseline)
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.
Measured: Baseline and end of intervention (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.
Measured: Baseline and end of the intervention (6 months from baseline)
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.
Measured: Baseline and end of the intervention (6 months from baseline)
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).
Measured: Baseline and end of intervention (6 months from baseline)
Change in team functioning.
The Collaborative Practice Assessment Tool will be administered to home care providers to assess changes in team functioning.
Measured: At three months into the intervention study and upon completion of the study (16 months)
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.
Measured: At three months into the intervention study and upon completion of the study (16 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study start8 May 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maureen Markle-Reid, McMaster University
- Investigators
- Maureen Markle-Reid, RN, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230280
- Sponsor's protocol ID
- STPILOT-134162
- Status last verified
- Mar 2019
- First submitted
- 28 Aug 2014
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Community-Based Stroke Care: A Pilot Study of a Community Navigation and Rehabilitation Intervention That Includes a Mobile Health Solution
- ClinicalTrials.gov ID
- NCT02230280
- Acronym / sponsor ID
- STPILOT-134162
- Conditions
- Stroke, Comorbidity, Chronic Disease
- Keywords
- Mobile health technology, Multiple chronic conditions, Older adults, Home and community care, Effectiveness, Cost analysis, Interprofessional Stroke Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 8 May 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 3 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The intervention cohort. | Other | Other: Strengthening Community-Based Stroke Care: A Pilot Study of a Community Navigation and Rehabilitation Intervention that Includes a Mobile Health SolutionA community transition and rehabilitation intervention that includes a mobile health solution |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants will be excluded if they are unable to read and understand English and do not have access to a translator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strengthening Community-Based Stroke Care: A Pilot Study of a Community Navigation and Rehabilitation Intervention that Includes a Mobile Health SolutionParticipants 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. | Other | The intervention cohort. |
Primary outcome
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)
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.
Time frame: At the end of the intervention (6 months)
Participants' perspectives on the feasibility of the mobile application will be assessed qualitatively through focus groups (HCPs) and interviews (stroke survivors and family caregivers).
9 secondary outcomes
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 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)
Change in prevalence and severity of anxiety.
Time frame: Baseline and end of 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 the community integration of stroke patients.
Time frame: Baseline and end of the intervention (6 months from baseline)
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 team functioning.
Time frame: At three months into the intervention study and upon completion of the study (16 months)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maureen Markle-Reid, RN, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strengthening Community-Based Stroke Care: A Pilot Study of a Community Navigation and Rehabilitation Intervention that Includes a Mobile Health Solution in people with Stroke and Comorbidity, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.