Optimizing Patient Adherence to Stroke Rehabilitation Treatment

NCT04440215 | Unknown

• 1 other identifier: MP-04-2020-519
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 6

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.

Conditions

Stroke Rehabilitation; Telerehabilitation; Decision Making, Shared

Keywords

Rehabilitation; Stroke; Adherence; Home; Telerehabilitation; Interprofessional shared decision making

Outcome Measures

Primary Outcomes (3)

• 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.

  Through intervention completion (up to 12 weeks)

• 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.

  Change from baseline and 4-, 6-, 12-week post-recruitment

• 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.

  Through intervention completion (up to 12 weeks)

Secondary Outcomes (12)

• Sociodemographic questionnaire

  At recruitment (baseline)

• Change in functional recovery and independence

  Change from baseline and 12-week post-recruitment

• Change in reintegration into normal social activities

  Change from baseline and 12-week post-recruitment

• Change in depression state

  Change from baseline and 12-week post-recruitment

• Use of healthcare services

  within 12 week and 6 month post recruitment

Study Arms (2)

Control

OTHER

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

Other: Usual care

Telerehabilitation

EXPERIMENTAL

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

Other: Telerehabilitation and team meetings and team care plans

Interventions

Telerehabilitation and team meetings and team care plans OTHER

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.

Telerehabilitation

Usual care OTHER

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Having severe cognitive decline prior to the stroke event

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Université de Montréal: collaborator
• Laval University: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (6)

Centre de réadaptation en déficience physique - Installation Châteauguay

Châteauguay, Quebec, J6J 4G7, Canada

RECRUITING

Centre de réadaptation en déficience physique - Installation Granby

Granby, Quebec, J2G 5L9, Canada

RECRUITING

Centre de réadaptation en déficiences physique - Installation Saint-Hubert

Longueuil, Quebec, J3Y 3N7, Canada

RECRUITING

Centre de réadaptation en déficience physique - Installation Longueuil

Longueuil, Quebec, J4J 1T2, Canada

RECRUITING

Centre de réadaptation en déficience physique - Installation Saint-Hyacinthe

Saint-Hyacinthe, Quebec, J2T 1N2, Canada

RECRUITING

Centre de réadaptation en déficience physique - Installation Vaudreuil-Dorion

Vaudreuil-Dorion, Quebec, J7V 7E4, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 34709196 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Central Study Contacts

Isabelle Gaboury, PhD

CONTACT

514-452-9078; isabelle.gaboury@usherbrooke.ca

Francois Bordeleau, MSc

CONTACT

514-550-0601; francois.bordeleau@usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 19, 2020
• Study Start: July 10, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)