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Optimizing Patient Adherence to Stroke Rehabilitation Treatment (Telestroke)

Primary Purpose

Stroke Rehabilitation, Telerehabilitation, Decision Making, Shared

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Telerehabilitation and team meetings and team care plans
Usual care
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke Rehabilitation focused on measuring Rehabilitation, Stroke, Adherence, Home, Telerehabilitation, Interprofessional shared decision making

Eligibility Criteria

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

Inclusion Criteria:

  • Have had stroke event (haemorrhagic or ischemic)
  • Are considered to be safe for home discharge by the acute/ in-patient care team (i.e. mild to moderate Functional Independence Measure score)
  • Have a relative or informal caregiver who is present in the home should physical rehabilitation treatments are required;
  • Can speak French or English.

Exclusion Criteria:

  • Having severe cognitive decline prior to the stroke event

Sites / Locations

  • Centre de réadaptation en déficience physique - Installation ChâteauguayRecruiting
  • Centre de réadaptation en déficience physique - Installation GranbyRecruiting
  • Centre de réadaptation en déficiences physique - Installation Saint-HubertRecruiting
  • Centre de réadaptation en déficience physique - Installation LongueuilRecruiting
  • Centre de réadaptation en déficience physique - Installation Saint-HyacintheRecruiting
  • Centre de réadaptation en déficience physique - Installation Vaudreuil-DorionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control

Telerehabilitation

Arm Description

Usual rehabilitation care (no telerehabilitation, interdisciplinary meetings not systematically organized and/or not involving a complete team of professionals)

A mix of home or rehabilitation center visits, telerehabilitation and interprofessional shared decision making process.

Outcomes

Primary Outcome Measures

Patient adherence to stroke rehabilitation plan (Patient journal)
Time spent (in minutes) doing any stroke rehabilitation exercises (online + offline). This includes (but is not limited to) physical, writing and speech therapy, and mental health-related exercises recommended by the rehabilitation professional.
Change in patient adherence to stroke rehabilitation plan
StREAM questionnaire which is a 12-item questionnaire coted on a 4-point Likert scale which measure patients' adherence to a rehabilitation program.
Patient adherence to stroke rehabilitation plan (Professional perception)
Health care professional perception of the participants' adherence to the rehabilitation program, evaluated on a 10-point scale.

Secondary Outcome Measures

Sociodemographic questionnaire
Home questionnaire including information about sex, age, clinical information about stroke
Change in functional recovery and independence
The modified 5-level Functional Independence Measure (FIM; 18 items) will be used. This measurement tool explores an individual's physical, psychological and social function. The tool is used to assess a patient's level of disability as well as change in patient status in response to rehabilitation or medical intervention. A lower score reflects greater disability.
Change in reintegration into normal social activities
The Reintegration to Normal Living Index (RNLI; 11 items) will be used to assess the degree to which the participants perceived their normal social activities have been impacted by the stroke event. A higher score indicates more difficulty to reintegrate normal living.
Change in depression state
The Beck Depression Inventory (Beck; 21 items) will be used to measure the severity of depression. The inventory is composed of items relating to depressive symptoms. A higher score indicates higher depression state.
Use of healthcare services
This outcome, defined as expenses related to services and long-term complications, including hospitalization and physician visits is measured with 3 different tools: 1) Section A - Use of healthcare services (16 items) of the questionnaire developed by the Institut National de Santé Publique du Québec (INSPQ), 2) information collected daily by the participant in a calendar and 3) Health administrative provincial data on use of public health services received.
Adverse events
Presence of adverse events related to rehabilitation (pain, dizziness, fatigue, number of falls)
Perception of interprofessional care shared decision making (Patient POV)
The Collaboration and Satisfaction About Care Decision tool (9 items) will be used. This questionnaire will be completed by the health care professionals involved in the study.
Perception of interprofessional care shared decision making (Clinical team POV)
The Assessment of Interprofessional Team Collaboration Scale, short version (AITCS; 23 items) will be used. This questionnaire will be completed by the health care professionals involved in the study.
Statistics related to the telerehabilitation platform use
Home questionnaire on telerehabilitation platform utilisation (who, when, duration).
Presence of intervention plan in the patient file
A "Yes" or "No" answer to the presence of an intervention plan in the patient file
Specific shared decision making (SDM) behaviours during decision-making (Questionnaire)
A composite questionnaire (SURE, 4 questions; Assumed role for decision-making, 1 question; CollaboRATE, 3 questions; Quality in decision-making, 6 questions) will be used to assess the extent to which practitioners involve patients in decision making processes. Patients will be given this questionnaire following the meeting to establish their rehabilitation plan.
Specific shared decision making (SDM) behaviours during decision-making (Interviews)
A randomized sample of 60 patients will be selected (50% control, 50% intervention). The meetings to establish their treatment plan will be recorded and analyzed using qualitative methods, in order to document the dynamics of the decision-making process. This qualitative section of the study will help enrich and contextualize the quantitative data collected for the other outcomes.

Full Information

First Posted
June 12, 2020
Last Updated
July 15, 2021
Sponsor
Université de Sherbrooke
Collaborators
Université de Montréal, Laval University, Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT04440215
Brief Title
Optimizing Patient Adherence to Stroke Rehabilitation Treatment
Acronym
Telestroke
Official Title
Optimizing Patient Adherence to Stroke Rehabilitation Treatment: a Telerehabilitation Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke
Collaborators
Université de Montréal, Laval University, Canadian Institutes of Health Research (CIHR)

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
Stroke impacts nearly 400,000 Canadians annually. Three quarters of stroke survivors will live with minor to severe impairments or disabilities; which require rehabilitation care. Strong evidence supports beginning rehabilitation as soon as the patient's medical status has stabilized and continuing following discharge from acute care. Access to optimal services is hampered, however, by travel distances to access rehabilitation, the lack of opportunities for structured and formal interprofessional communication among service providers, and failures to engage the patient and family members in a structured decision making process. Moreover, adherence to rehabilitation treatments has been shown to be suboptimal. Many patients refuse their outpatient rehabilitation treatments outright or decrease the duration and/or frequency of their treatments over time. The aim of this proposed mixed methods pragmatic clinical trial is to evaluate an intervention that provides patients who have experienced stroke the opportunity to return home safely after their acute hospital stay, to encourage patient (and family) engagement in their rehabilitation care, and to overcome challenges of access to patient-centered interprofessional rehabilitation care. The proposed intervention will entail 220 patients (and family) to receive rehabilitation care through remote, live treatment sessions with an interdisciplinary group of clinicians (called telerehabilitation) versus standard of care (n = 110 patients). Five rehabilitation teams will be trained to develop rehabilitation treatment plans that engage the patient and family, while taking advantage of a telerehabilitation platform to engage the patient/family. Grounded in findings gathered through a Canadian Institute of Health Research (CIHR) funded pilot study, the primary study objective is to evaluate process, clinical outcomes and costs of telerehabilitation in comparison with usual care. Through qualitative interviews with patients and family as well as clinicians, a second objective of this pragmatic, controlled trial is to explore and describe contextual factors (both personal and environmental) that will help the delivery of care, and improve patient's outcomes while fully using technology to deliver stroke rehabilitation care. This study represents a unique, highly relevant opportunity to minimize both knowledge and practice gaps, while producing robust, indepth data on the factors related to the effectiveness of telerehabilitation.
Detailed Description
Stroke impacts nearly 400,000 Canadians annually. Three quarters of stroke survivors will live with minor to severe impairments or disabilities; which require rehabilitation care representing >$3.6 billion in Canadian healthcare expenditure every year. Strong evidence supports beginning rehabilitation as soon as the patient's medical status has stabilized and continuing following discharge from acute care, ideally in the patient's community. Access to optimal services is hampered, however, by travel distances to access rehabilitation, the lack of opportunities for structured and formal interprofessional communication among service providers, and failures to engage the patient and family members in a structured decision making process. Even when travel is not a barrier, adherence to rehabilitation treatments has been shown to be suboptimal. Many patients refuse their outpatient rehabilitation treatments outright or decrease the duration and/or frequency of their treatments over time. The aim of this proposed mixed methods pragmatic clinical trial is to evaluate an intervention that provides patients who have experienced stroke the opportunity to return home safely after their acute hospital stay, to encourage patient (and family) engagement in their rehabilitation care, and to overcome challenges of access to patient-centered interprofessional rehabilitation care. The proposed intervention will entail 220 patients (and family) to receive rehabilitation care through remote, live treatment sessions with an interdisciplinary group of clinicians (called telerehabilitation) versus standard of care (n = 110 patients). Five rehabilitation teams will be trained to develop rehabilitation treatment plans that engage the patient and family, while taking advantage of a telerehabilitation platform to engage the patient/family. Grounded in findings gathered through a CIHR funded pilot study, the primary study objective is to evaluate process, clinical outcomes and costs of telerehabilitation in comparison with usual care. Through qualitative interviews with patients and family as well as clinicians, a second objective of this pragmatic, controlled trial is to explore and describe contextual factors (both personal and environmental) that will help the delivery of care, and improve patient's outcomes while fully using technology to deliver stroke rehabilitation care. This application has been developed by an interdisciplinary team of researchers, local healthcare providers from each region involved, two patient partners who have experienced stroke, provincial network stakeholders, and decision makers, all engaged in the successful implementation of stroke guidelines and jurisdictional strategic plans. A panel of Canadian health system knowledge users rounds out the team, to enhance the proposed intervention, to communicate the relevance and anticipated use of the findings within their province, and to foster adaptation of improved stroke care elsewhere. Finally, the study has been endorsed by several knowledge users from the Quebec Ministry of Health as well as the Quebec Heart and Stroke Foundation. Considering contrasts between rehabilitation practices and the Canadian Stroke recommendations and the lack of relevant, robust data, this study represents a unique, highly relevant opportunity to minimize both knowledge and practice gaps, while producing robust, indepth data on the factors related to the effectiveness of telerehabilitation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Rehabilitation, Telerehabilitation, Decision Making, Shared
Keywords
Rehabilitation, Stroke, Adherence, Home, Telerehabilitation, Interprofessional shared decision making

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
An interrupted time series design. It consists of observing the same dependent variable over time, with a break in the series of observations corresponding to the introduction of an intervention.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
Usual rehabilitation care (no telerehabilitation, interdisciplinary meetings not systematically organized and/or not involving a complete team of professionals)
Arm Title
Telerehabilitation
Arm Type
Experimental
Arm Description
A mix of home or rehabilitation center visits, telerehabilitation and interprofessional shared decision making process.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation and team meetings and team care plans
Intervention Description
A mix of home or rehabilitation center visits and telerehabilitation will be planned by the rehabilitation team for a maximum of 16 weeks. Moreover, for each participant enrolled, a multidisciplinary meeting will be organised. The patient/family will participate in the meeting and the decision making process using the telerehabilitation platform. The team will generate an interprofessional individualized treatment plan, aiming for an interprofessional shared decision making process.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Rehabilitation teams will be instructed to provide care as they have been doing previously. Currently, this translates into no telerehabilitation, and interdisciplinary meetings not systematically organized and/or not involving a complete team of professionals.
Primary Outcome Measure Information:
Title
Patient adherence to stroke rehabilitation plan (Patient journal)
Description
Time spent (in minutes) doing any stroke rehabilitation exercises (online + offline). This includes (but is not limited to) physical, writing and speech therapy, and mental health-related exercises recommended by the rehabilitation professional.
Time Frame
Through intervention completion (up to 12 weeks)
Title
Change in patient adherence to stroke rehabilitation plan
Description
StREAM questionnaire which is a 12-item questionnaire coted on a 4-point Likert scale which measure patients' adherence to a rehabilitation program.
Time Frame
Change from baseline and 4-, 6-, 12-week post-recruitment
Title
Patient adherence to stroke rehabilitation plan (Professional perception)
Description
Health care professional perception of the participants' adherence to the rehabilitation program, evaluated on a 10-point scale.
Time Frame
Through intervention completion (up to 12 weeks)
Secondary Outcome Measure Information:
Title
Sociodemographic questionnaire
Description
Home questionnaire including information about sex, age, clinical information about stroke
Time Frame
At recruitment (baseline)
Title
Change in functional recovery and independence
Description
The modified 5-level Functional Independence Measure (FIM; 18 items) will be used. This measurement tool explores an individual's physical, psychological and social function. The tool is used to assess a patient's level of disability as well as change in patient status in response to rehabilitation or medical intervention. A lower score reflects greater disability.
Time Frame
Change from baseline and 12-week post-recruitment
Title
Change in reintegration into normal social activities
Description
The Reintegration to Normal Living Index (RNLI; 11 items) will be used to assess the degree to which the participants perceived their normal social activities have been impacted by the stroke event. A higher score indicates more difficulty to reintegrate normal living.
Time Frame
Change from baseline and 12-week post-recruitment
Title
Change in depression state
Description
The Beck Depression Inventory (Beck; 21 items) will be used to measure the severity of depression. The inventory is composed of items relating to depressive symptoms. A higher score indicates higher depression state.
Time Frame
Change from baseline and 12-week post-recruitment
Title
Use of healthcare services
Description
This outcome, defined as expenses related to services and long-term complications, including hospitalization and physician visits is measured with 3 different tools: 1) Section A - Use of healthcare services (16 items) of the questionnaire developed by the Institut National de Santé Publique du Québec (INSPQ), 2) information collected daily by the participant in a calendar and 3) Health administrative provincial data on use of public health services received.
Time Frame
within 12 week and 6 month post recruitment
Title
Adverse events
Description
Presence of adverse events related to rehabilitation (pain, dizziness, fatigue, number of falls)
Time Frame
Through intervention completion (up to 12 weeks)
Title
Perception of interprofessional care shared decision making (Patient POV)
Description
The Collaboration and Satisfaction About Care Decision tool (9 items) will be used. This questionnaire will be completed by the health care professionals involved in the study.
Time Frame
12 weeks after recruitment
Title
Perception of interprofessional care shared decision making (Clinical team POV)
Description
The Assessment of Interprofessional Team Collaboration Scale, short version (AITCS; 23 items) will be used. This questionnaire will be completed by the health care professionals involved in the study.
Time Frame
Through study completion (up to 5 years)
Title
Statistics related to the telerehabilitation platform use
Description
Home questionnaire on telerehabilitation platform utilisation (who, when, duration).
Time Frame
Through intervention period (up to 3 years)
Title
Presence of intervention plan in the patient file
Description
A "Yes" or "No" answer to the presence of an intervention plan in the patient file
Time Frame
12 weeks after recruitment
Title
Specific shared decision making (SDM) behaviours during decision-making (Questionnaire)
Description
A composite questionnaire (SURE, 4 questions; Assumed role for decision-making, 1 question; CollaboRATE, 3 questions; Quality in decision-making, 6 questions) will be used to assess the extent to which practitioners involve patients in decision making processes. Patients will be given this questionnaire following the meeting to establish their rehabilitation plan.
Time Frame
At the start of the rehabilitation period
Title
Specific shared decision making (SDM) behaviours during decision-making (Interviews)
Description
A randomized sample of 60 patients will be selected (50% control, 50% intervention). The meetings to establish their treatment plan will be recorded and analyzed using qualitative methods, in order to document the dynamics of the decision-making process. This qualitative section of the study will help enrich and contextualize the quantitative data collected for the other outcomes.
Time Frame
At the start of the rehabilitation period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have had stroke event (haemorrhagic or ischemic) Are considered to be safe for home discharge by the acute/ in-patient care team (i.e. mild to moderate Functional Independence Measure score) Have a relative or informal caregiver who is present in the home should physical rehabilitation treatments are required; Can speak French or English. Exclusion Criteria: Having severe cognitive decline prior to the stroke event
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle Gaboury, PhD
Phone
514-452-9078
Email
isabelle.gaboury@usherbrooke.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Francois Bordeleau, MSc
Phone
514-550-0601
Email
francois.bordeleau@usherbrooke.ca
Facility Information:
Facility Name
Centre de réadaptation en déficience physique - Installation Châteauguay
City
Châteauguay
State/Province
Quebec
ZIP/Postal Code
J6J 4G7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane Aspirot
Email
diane.aspirot.cisssmo16@ssss.gouv.qc.ca
Facility Name
Centre de réadaptation en déficience physique - Installation Granby
City
Granby
State/Province
Quebec
ZIP/Postal Code
J2G 5L9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadine Morin
Phone
450-777-4641
Ext
300
Email
nadine.morin.cisssmo16@ssss.gouv.qc.ca
Facility Name
Centre de réadaptation en déficiences physique - Installation Saint-Hubert
City
Longueuil
State/Province
Quebec
ZIP/Postal Code
J3Y 3N7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Mills
Phone
(450) 676-7447
Ext
2272
Email
christine.mills.cisssmo16@ssss.gouv.qc.ca
Facility Name
Centre de réadaptation en déficience physique - Installation Longueuil
City
Longueuil
State/Province
Quebec
ZIP/Postal Code
J4J 1T2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Laniel
Phone
(450) 676-7447
Ext
2279
Email
sophie.laniel.cisssmo16@ssss.gouv.qc.ca
Facility Name
Centre de réadaptation en déficience physique - Installation Saint-Hyacinthe
City
Saint-Hyacinthe
State/Province
Quebec
ZIP/Postal Code
J2T 1N2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadine Morin
Phone
450-774-5003
Ext
2246
Email
nadine.morin.cisssmo16@ssss.gouv.qc.ca
Facility Name
Centre de réadaptation en déficience physique - Installation Vaudreuil-Dorion
City
Vaudreuil-Dorion
State/Province
Quebec
ZIP/Postal Code
J7V 7E4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane Aspirot
Email
diane.aspirot.cisssmo16@ssss.gouv.qc.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34709196
Citation
Gaboury I, Tousignant M, Corriveau H, Menear M, Le Dorze G, Rochefort C, Vachon B, Rochette A, Gosselin S, Michaud F, Bollen J, Dean S. Effects of Telerehabilitation on Patient Adherence to a Rehabilitation Plan: Protocol for a Mixed Methods Trial. JMIR Res Protoc. 2021 Oct 28;10(10):e32134. doi: 10.2196/32134.
Results Reference
derived

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Optimizing Patient Adherence to Stroke Rehabilitation Treatment

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