Optimizing Patient Adherence to Stroke Rehabilitation Treatment

Telerehabilitation Clinical Trial

— Telestroke  

Official title:

Optimizing Patient Adherence to Stroke Rehabilitation Treatment: a Telerehabilitation Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04440215
• Other study ID #: MP-04-2020-519
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: July 2021
• Source: Université de Sherbrooke
• Contact: Isabelle Gaboury, PhD
• Phone: 514-452-9078
• Email: isabelle.gaboury[@]usherbrooke.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Decision Making, Shared
• Stroke
• Stroke Rehabilitation
• Telerehabilitation

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Centre de réadaptation en déficience physique - Installation Châteauguay	Châteauguay	Quebec
Canada	Centre de réadaptation en déficience physique - Installation Granby	Granby	Quebec
Canada	Centre de réadaptation en déficience physique - Installation Longueuil	Longueuil	Quebec
Canada	Centre de réadaptation en déficiences physique - Installation Saint-Hubert	Longueuil	Quebec
Canada	Centre de réadaptation en déficience physique - Installation Saint-Hyacinthe	Saint-Hyacinthe	Quebec
Canada	Centre de réadaptation en déficience physique - Installation Vaudreuil-Dorion	Vaudreuil-Dorion	Quebec

Sponsors (4)

Lead Sponsor	Collaborator
Université de Sherbrooke	Canadian Institutes of Health Research (CIHR), Laval University, Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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	Sociodemographic questionnaire	Home questionnaire including information about sex, age, clinical information about stroke	At recruitment (baseline)
Secondary	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 from baseline and 12-week post-recruitment
Secondary	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 from baseline and 12-week post-recruitment
Secondary	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.	Change from baseline and 12-week post-recruitment
Secondary	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.	within 12 week and 6 month post recruitment
Secondary	Adverse events	Presence of adverse events related to rehabilitation (pain, dizziness, fatigue, number of falls)	Through intervention completion (up to 12 weeks)
Secondary	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.	12 weeks after recruitment
Secondary	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.	Through study completion (up to 5 years)
Secondary	Statistics related to the telerehabilitation platform use	Home questionnaire on telerehabilitation platform utilisation (who, when, duration).	Through intervention period (up to 3 years)
Secondary	Presence of intervention plan in the patient file	A "Yes" or "No" answer to the presence of an intervention plan in the patient file	12 weeks after recruitment
Secondary	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.	At the start of the rehabilitation period
Secondary	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.	At the start of the rehabilitation period