NCT02230280

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 3, 2014

Completed
2.7 years until next milestone

Study Start

First participant enrolled

May 8, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

12 months

First QC Date

August 28, 2014

Last Update Submit

March 5, 2019

Conditions

Keywords

Mobile health technologyMultiple chronic conditionsOlder adultsHome and community careEffectivenessCost analysisInterprofessional Stroke Rehabilitation

Outcome Measures

Primary Outcomes (2)

  • 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

    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).

    At the end of the intervention (6 months)

Secondary Outcomes (9)

  • Changes in the degree of physical functioning related to stroke.

    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.

    Baseline and the end of the intervention (6 months from baseline)

  • Change in the degree of strain of family caregiver.

    Baseline and the end of the intervention (6months from baseline)

  • Change in prevalence and severity of anxiety.

    Baseline and end of intervention (6 months from baseline)

  • Change in the self efficacy of stroke survivors.

    Baseline and end of the intervention (6 months from baseline)

  • +4 more secondary outcomes

Study Arms (1)

The intervention cohort.

OTHER

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

Other: Strengthening Community-Based Stroke Care: A Pilot Study of a Community Navigation and Rehabilitation Intervention that Includes a Mobile Health Solution

Interventions

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.

The intervention cohort.

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, L8S 4L8, Canada

Location

MeSH Terms

Conditions

StrokeChronic DiseaseMultiple Chronic Conditions

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maureen Markle-Reid, RN, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Canada Research Chair

Study Record Dates

First Submitted

August 28, 2014

First Posted

September 3, 2014

Study Start

May 8, 2017

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

March 6, 2019

Record last verified: 2019-03

Locations