Clinical trial NCT04440215: Optimizing Patient Adherence to Stroke Rehabilitation Treatment
Official title: Optimizing Patient Adherence to Stroke Rehabilitation Treatment: a Telerehabilitation Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke Rehabilitation
Telerehabilitation
Decision Making, Shared
Keywords: Rehabilitation
Stroke
Adherence
Home
Telerehabilitation
Interprofessional shared decision making
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Université de Montréal
name: Laval University
name: Canadian Institutes of Health Research (CIHR)
First posted: 2020-06-19
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Patient adherence to stroke rehabilitation plan (Patient journal)
timeFrame: Through intervention completion (up to 12 weeks)
measure: Change in patient adherence to stroke rehabilitation plan
timeFrame: Change from baseline and 4-, 6-, 12-week post-recruitment
measure: Patient adherence to stroke rehabilitation plan (Professional perception)
timeFrame: Through intervention completion (up to 12 weeks)
Secondary outcomes:
measure: Sociodemographic questionnaire
timeFrame: At recruitment (baseline)
measure: Change in functional recovery and independence
timeFrame: Change from baseline and 12-week post-recruitment
measure: Change in reintegration into normal social activities
timeFrame: Change from baseline and 12-week post-recruitment
measure: Change in depression state
timeFrame: Change from baseline and 12-week post-recruitment
measure: Use of healthcare services
timeFrame: within 12 week and 6 month post recruitment
measure: Adverse events
timeFrame: Through intervention completion (up to 12 weeks)
measure: Perception of interprofessional care shared decision making (Patient POV)
timeFrame: 12 weeks after recruitment
measure: Perception of interprofessional care shared decision making (Clinical team POV)
timeFrame: Through study completion (up to 5 years)
measure: Statistics related to the telerehabilitation platform use
timeFrame: Through intervention period (up to 3 years)
measure: Presence of intervention plan in the patient file
timeFrame: 12 weeks after recruitment
measure: Specific shared decision making (SDM) behaviours during decision-making (Questionnaire)
timeFrame: At the start of the rehabilitation period
measure: Specific shared decision making (SDM) behaviours during decision-making (Interviews)
timeFrame: At the start of the rehabilitation period
Other outcomes:
Locations:
city: Châteauguay
country: Canada
facility: Centre de réadaptation en déficience physique - Installation Châteauguay
state: Quebec
city: Granby
country: Canada
facility: Centre de réadaptation en déficience physique - Installation Granby
state: Quebec
city: Longueuil
country: Canada
facility: Centre de réadaptation en déficiences physique - Installation Saint-Hubert
state: Quebec
city: Longueuil
country: Canada
facility: Centre de réadaptation en déficience physique - Installation Longueuil
state: Quebec
city: Saint-Hyacinthe
country: Canada
facility: Centre de réadaptation en déficience physique - Installation Saint-Hyacinthe
state: Quebec
city: Vaudreuil-Dorion
country: Canada
facility: Centre de réadaptation en déficience physique - Installation Vaudreuil-Dorion
state: Quebec
Study officials:
References:
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.