Stroke RehabilitationTelestrokeNCT04440215
Optimizing Patient Adherence to Stroke Rehabilitation Treatment
A study testing Telerehabilitation and team meetings and team care plans in people with Stroke Rehabilitation and Telerehabilitation, run by Université de Sherbrooke at 6 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Rehabilitation, Telerehabilitation, Decision Making, Shared
- What is being tested?
- Telerehabilitation and team meetings and team care plans
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 6 sitesCanada
- Study dates
- 10 Jul 2020to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Having severe cognitive decline prior to the stroke event
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites, 6 recruiting
- Recruiting
Centre de réadaptation en déficience physique - Installation Châteauguay
Châteauguay, Quebec, J6J 4G7
Diane Aspirot, diane.aspirot.cisssmo16@ssss.gouv.qc.ca
- Recruiting
Centre de réadaptation en déficience physique - Installation Granby
Granby, Quebec, J2G 5L9
Nadine Morin, 450-777-4641 ext. 300, nadine.morin.cisssmo16@ssss.gouv.qc.ca
- Recruiting
Centre de réadaptation en déficiences physique - Installation Saint-Hubert
Longueuil, Quebec, J3Y 3N7
Christine Mills, (450) 676-7447 ext. 2272, christine.mills.cisssmo16@ssss.gouv.qc.ca
- Recruiting
Centre de réadaptation en déficience physique - Installation Longueuil
Longueuil, Quebec, J4J 1T2
Sophie Laniel, (450) 676-7447 ext. 2279, sophie.laniel.cisssmo16@ssss.gouv.qc.ca
- Recruiting
Centre de réadaptation en déficience physique - Installation Saint-Hyacinthe
Saint-Hyacinthe, Quebec, J2T 1N2
Nadine Morin, 450-774-5003 ext. 2246, nadine.morin.cisssmo16@ssss.gouv.qc.ca
- Recruiting
Centre de réadaptation en déficience physique - Installation Vaudreuil-Dorion
Vaudreuil-Dorion, Quebec, J7V 7E4
Diane Aspirot, diane.aspirot.cisssmo16@ssss.gouv.qc.ca
About this study
Official title: Optimizing Patient Adherence to Stroke Rehabilitation Treatment: a Telerehabilitation Trial
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.
Read more
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.
Read the 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.
- Being tested
- Telerehabilitation and team meetings and team care plans, Usual care
- Keywords
- Rehabilitation, Stroke, Adherence, Home, Telerehabilitation, Interprofessional shared decision making
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation and team meetings and team care plansOther
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Usual rehabilitation care (no telerehabilitation, interdisciplinary meetings not systematically organized and/or not involving a complete team of professionals) Receives: Other: Usual care |
| Telerehabilitation | Experimental | A mix of home or rehabilitation center visits, telerehabilitation and interprofessional shared decision making process. Receives: Other: Telerehabilitation and team meetings and team care plans |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Through intervention completion (up to 12 weeks)
Secondary outcomes (12)
Sociodemographic questionnaire
Home questionnaire including information about sex, age, clinical information about stroke
Measured: At recruitment (baseline)
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.
Measured: Change from baseline and 12-week post-recruitment
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.
Measured: Change from baseline and 12-week post-recruitment
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.
Measured: Change from baseline and 12-week post-recruitment
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.
Measured: within 12 week and 6 month post recruitment
Adverse events
Presence of adverse events related to rehabilitation (pain, dizziness, fatigue, number of falls)
Measured: Through intervention completion (up to 12 weeks)
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.
Measured: 12 weeks after recruitment
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.
Measured: Through study completion (up to 5 years)
Statistics related to the telerehabilitation platform use
Home questionnaire on telerehabilitation platform utilisation (who, when, duration).
Measured: Through intervention period (up to 3 years)
Presence of intervention plan in the patient file
A "Yes" or "No" answer to the presence of an intervention plan in the patient file
Measured: 12 weeks after recruitment
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.
Measured: At the start of the rehabilitation period
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.
Measured: At the start of the rehabilitation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start10 Jul 2020
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke RehabilitationStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal, Laval University, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Isabelle Gaboury, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440215
- Sponsor's protocol ID
- MP-04-2020-519
- Acronym
- Telestroke
- Status last verified
- Jul 2021
- First submitted
- 12 Jun 2020
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34709196
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Patient Adherence to Stroke Rehabilitation Treatment: a Telerehabilitation Trial
- ClinicalTrials.gov ID
- NCT04440215
- Acronym / sponsor ID
- Telestroke / MP-04-2020-519
- Keywords
- Rehabilitation, Stroke, Adherence, Home, Telerehabilitation, Interprofessional shared decision making
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Université de Montréal, Laval University, Canadian Institutes of Health Research (CIHR)
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Usual careUsual rehabilitation care (no telerehabilitation, interdisciplinary meetings not systematically organized and/or not involving a complete team of professionals) |
| Telerehabilitation | Experimental | Other: Telerehabilitation and team meetings and team care plansA mix of home or rehabilitation center visits, telerehabilitation and interprofessional shared decision making process. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Having severe cognitive decline prior to the stroke event
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telerehabilitation and team meetings and team care plansA 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. | Other | Telerehabilitation |
| Usual careRehabilitation 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. | Other | Control |
Primary outcome
Patient adherence to stroke rehabilitation plan (Patient journal)
Time frame: Through intervention completion (up to 12 weeks)
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
Time frame: Change from baseline and 4-, 6-, 12-week post-recruitment
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)
Time frame: Through intervention completion (up to 12 weeks)
Health care professional perception of the participants' adherence to the rehabilitation program, evaluated on a 10-point scale.
12 secondary outcomes
Sociodemographic questionnaire
Time frame: At recruitment (baseline)
Change in functional recovery and independence
Time frame: Change from baseline and 12-week post-recruitment
Change in reintegration into normal social activities
Time frame: Change from baseline and 12-week post-recruitment
Change in depression state
Time frame: Change from baseline and 12-week post-recruitment
Use of healthcare services
Time frame: within 12 week and 6 month post recruitment
Adverse events
Time frame: Through intervention completion (up to 12 weeks)
Perception of interprofessional care shared decision making (Patient POV)
Time frame: 12 weeks after recruitment
Perception of interprofessional care shared decision making (Clinical team POV)
Time frame: Through study completion (up to 5 years)
Statistics related to the telerehabilitation platform use
Time frame: Through intervention period (up to 3 years)
Presence of intervention plan in the patient file
Time frame: 12 weeks after recruitment
Specific shared decision making (SDM) behaviours during decision-making (Questionnaire)
Time frame: At the start of the rehabilitation period
Specific shared decision making (SDM) behaviours during decision-making (Interviews)
Time frame: At the start of the rehabilitation period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Derived from this study: PubMed 34709196Gaboury 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation and team meetings and team care plans in people with Stroke Rehabilitation and Telerehabilitation, run by Université de Sherbrooke at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Gaboury, PhD (514-452-9078, isabelle.gaboury@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient adherence to stroke rehabilitation plan (Patient journal) (time frame: Through intervention completion (up to 12 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04440215, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.