Recruiting

Stroke Rehabilitation

Sponsor:

Université de Sherbrooke

Code:

NCT04440215

Conditions

Stroke Rehabilitation

Telerehabilitation

Decision Making, Shared

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Telerehabilitation and team meetings and team care plans

Usual care

Study Details

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

Study ID

NCT04440215

Start date

Jul 10, 2020

Status verified date

Jul, 2021

Completion date

Dec 1, 2024

Anticipated

Primary completion date

Dec 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

330 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: Control

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

experimental: Telerehabilitation

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

Interventions

Telerehabilitation and team meetings and team care plans

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.

Usual care

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

  • Patient adherence to stroke rehabilitation plan (Patient journal) [ Time Frame: Through intervention completion (up to 12 weeks) ]
  • Change in patient adherence to stroke rehabilitation plan [ Time Frame: Change from baseline and 4-, 6-, 12-week post-recruitment ]
  • Patient adherence to stroke rehabilitation plan (Professional perception) [ Time Frame: Through intervention completion (up to 12 weeks) ]

Central Contacts and Locations

Central contacts

Locations

Centre de réadaptation en déficience physique - Installation Châteauguay

Recruiting

Châteauguay, Quebec, Canada, J6J 4G7

Contacts

Centre de réadaptation en déficience physique - Installation Granby

Recruiting

Granby, Quebec, Canada, J2G 5L9

Contacts

Centre de réadaptation en déficiences physique - Installation Saint-Hubert

Recruiting

Longueuil, Quebec, Canada, J3Y 3N7

Contacts

Centre de réadaptation en déficience physique - Installation Longueuil

Recruiting

Longueuil, Quebec, Canada, J4J 1T2

Contacts

Centre de réadaptation en déficience physique - Installation Saint-Hyacinthe

Recruiting

Saint-Hyacinthe, Quebec, Canada, J2T 1N2

Contacts

Centre de réadaptation en déficience physique - Installation Vaudreuil-Dorion

Recruiting

Vaudreuil-Dorion, Quebec, Canada, J7V 7E4

Contacts

More Information

Sponsor

Université de Sherbrooke

Last update posted

Jul 21, 2021

Last verified

Jul, 2021

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2021-07-21.