RehabilitationNCT03991858
Implementation of Telerehabilitation as Modality of Patient Follow-up on the Waiting List of a Clinic
A study testing Phone call follow-up and Telerehabilitation follow-up in people with Rehabilitation and Orthopedic Disorder, run by Université de Sherbrooke at 2 sites in Canada.
Trial summary
This study responds to the need to validate the feasibility and effectiveness of a telerehabilitation home monitoring program for users receiving a preliminary assessment while waiting for rehabilitation services at the outpatient physiotherapy clinic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rehabilitation, Orthopedic Disorder
- What is being tested?
- Phone call follow-up and Telerehabilitation follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 2 sitesCanada
- Study dates
- 13 Mar 2019to 22 Jul 2021
- 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
- To present a non-urgent condition (status determined during the initial evaluation at the clinic)
- To be apt to understand simple statement
- To have access to internet at and possess an electronic tablet or a computer at
Who cannot join
- Do not understand French or English
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Research Center on Aging
Sherbrooke, Quebec, J1H 4C4
Research Centre on Aging
Sherbrooke
About this study
Official title: Implementation of Telerehabilitation as an Innovative Modality of Patient Follow-up on the Waiting List of the External Rehabilitation Clinic of the CIUSSS de l'Estrie-CHUS.
This study responds to the need to validate the feasibility and effectiveness of a telerehabilitation home monitoring program for users receiving a preliminary assessment while waiting for rehabilitation services at the outpatient physiotherapy clinic. The specific objectives are as followed: 1) Evaluate the implementation of telerehabilitation monitoring (TELE-FOLLOW-UP); 2) Evaluate the effectiveness of TELE-FOLLOW-UP compared to the usual phone call; 3) Evaluate user satisfaction for these two modes of service delivery; 4) Identify facilitators and barriers to the implementation of TELE-FOLLOW-UP. In order to meet the objectives of the study, mixed methods will be used. A randomized clinical trial will be used to achieve objectives 1, 2 and 3. The investigators plan to recruit 142 patients. Two groups will be formed: 1) TELE-FOLLOW-UP group: users who will receive follow-up by telerehabilitation; 2) PHONE-FOLLOW-UP group: those who will receive follow-up by a phone call.
Read the detailed description
Rational : The rehabilitation service offered at the Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS) for non-hospitalized patients is performed in outpatient clinics. However, the demand for this service far exceeds the supply, so the take-up time is very long. Recognizing the threatened short-term accessibility, this outpatient clinic has put in place an initial assessment for any service request. The goal is to conduct a preliminary assessment of the condition of the user to teach an exercise and education program. In addition, sporadic monitoring is recommended to promote the effectiveness of the intervention.
To date, the follow-up of this preliminary assessment is done by a phone call from the professional to the patient one month later. However, it is noted that this type of monitoring is not optimal for various reasons, in particular because of the absence of visual contact with the user to allow appropriate feedback from the professional on the exercise execution. In this context, the possibility of having a follow-up by a physiotherapist using telerehabilitation, an application of information technologies allowing a synchronous auditory and visual link, would be an innovative way of increasing the effectiveness of the intervention. This study therefore responds to the need to validate the feasibility and effectiveness of a telerehabilitation home monitoring program for users receiving a preliminary assessment while waiting for physiotherapist at the outpatient physiotherapy clinic. The results of this study will be relevant to clinicians and managers and will undeniably influence the provision of rehabilitation services.
Objectives: The specific objectives are as followed: 1) Evaluate the implementation of telerehabilitation monitoring (TELE-FOLLOW-UP); 2) Evaluate the effectiveness of TELE-FOLLOW-UP compared to the usual phone call; 3) Evaluate user satisfaction for these two modes of service delivery; 4) Identify facilitators and barriers to the implementation of TELE-FOLLOW-UP.
Methodology : In order to meet the objectives of the study, mixed methods will be used. A randomized clinical trial will be used to achieve objectives 1, 2 and 3. The investigators plan to recruit 142 patients. Two groups will be formed: 1) TELE-FOLLOW-UP group: users who will receive follow-up by telerehabilitation; 2) PHONE-FOLLOW-UP group: those who will receive follow-up by a phone call. In order to complete Objective 4, a qualitative exploratory and descriptive study will be conducted using individual interviews (clinicians and health care managers) and focus groups (participants).
The successful implementation of this project will bring a unique experience in Quebec of implementing telerehabilitation in a health care facility. The CIUSSS de l'Estrie-CHUS could become a leader in sharing its experience for large-scale implementation in Quebec. The application in orthopedic outpatient clinics may be generalized to other clientele by increasing accessibility to rehabilitation services for clients where accessibility is an issue
- Conditions
- Rehabilitation, Orthopedic Disorder
- Being tested
- Phone call follow-up, Telerehabilitation follow-up
- Keywords
- Rehabilitation, Telerehabilitation, Waiting list, follow-up
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone call follow-upOther
A physical therapist made a phone call to the patient one month after his/her initial evaluation at the external rehabilitation clinic
Telerehabilitation follow-upOther
A physical therapist made a direct follow-up through telerehabilitation to the patient one month after his/her initial evaluation at the external rehabilitation clinic
| Study group | Role | What they receive |
|---|---|---|
| Phone follow-up | Other | Phone follow-up initiated by the health care professional one month after the initial evaluation at the external rehabilitation clinic. Receives: Other: Phone call follow-up |
| Telerehabilitation follow-up | Experimental | Telerehabilitation follow-up initiated by the health care professional one month after the initial evaluation at the external rehabilitation clinic. Receives: Other: Telerehabilitation follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain through time
0-10 pain scale (0= no pain, 10 = worst pain)
Measured: Day 0, 1 month
Secondary outcomes (3)
Change in quality of life through time
Evaluate quality of life related to physical and mental state (Questionnaire SF-6Dv2 (Health Utility Survey)). This questionnaire provide a multidimensional generic measure of health-related quality of life. In its current form, this questionnaire includes six questions on different aspects of physical and mental health. The score will be converted to QALY (quality-adjusted life year).The cost-utility analysis (CUA) is an increasingly used method to help health decision-maker. The CUA uses the Quality Adjusted Life Years (QALY) that combines the length of life with the health related quality of life (HRQoL) into a single score.
Measured: Day 0, 12 months
Direct and indirect costs related to intervention
Indirect and direct costs related to intervention. Direct costs are the costs that are essentials for clinical follow-up and refer to the physiotherapists salary and the acquisition of technological equipment (tablet or computer) used by the patient. Indirect costs are needed to optimize the performance of clinical follow-up and take into account the patient's expenses and / or any other necessary expenses related to his/her participation in the RT program. A home-made questionnaire will be administered to collect information about costs.
Measured: 12 months
Satisfaction with service received
Questionnaire about satisfaction of health care received. The satisfaction construct is determined by three distinct factors which include satisfaction with:
- the therapist relationship, 2) the services provided, and 3) the organization of services. This tool includes 26 questions, scored on a four-point Likert scale. The total score is calculated based on average satisfaction for the three factors, with higher scores indicating higher levels of satisfaction (on a 0-100 scale)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start13 Mar 2019
- Primary completion2 Sep 2020
- Study completion22 Jul 2021
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 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Ministère de l'Économie, de la Science et de l'Innovation
- Responsible party
- Principal investigator, Michel Tousignant, Université de Sherbrooke
- Investigators
- Michel Tousignant, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991858
- Sponsor's protocol ID
- 2019-2919
- Status last verified
- Sep 2021
- First submitted
- 2 May 2019
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Renard M, Gaboury I, Michaud F, Tousignant M. The acceptability of two remote monitoring modalities for patients waiting for services in a physiotherapy outpatient clinic. Musculoskeletal Care. 2022 Sep;20(3):616-624. doi: 10.1002/msc.1622. Epub 2022 Feb 10.
PubMed 35142425
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Telerehabilitation as an Innovative Modality of Patient Follow-up on the Waiting List of the External Rehabilitation Clinic of the CIUSSS de l'Estrie-CHUS.
- ClinicalTrials.gov ID
- NCT03991858
- Acronym / sponsor ID
- 2019-2919
- Conditions
- Rehabilitation, Orthopedic Disorder
- Keywords
- Rehabilitation, Telerehabilitation, Waiting list, follow-up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Ministère de l'Économie, de la Science et de l'Innovation
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 2 Sep 2020 (actual)
- Study completion
- 22 Jul 2021 (actual)
- First posted
- 19 Jun 2019 (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.
This study responds to the need to validate the feasibility and effectiveness of a telerehabilitation home monitoring program for users receiving a preliminary assessment while waiting for rehabilitation services at the outpatient physiotherapy clinic. The specific objectives are as followed: 1) Evaluate the implementation of telerehabilitation monitoring (TELE-FOLLOW-UP); 2) Evaluate the effectiveness of TELE-FOLLOW-UP compared to the usual phone call; 3) Evaluate user satisfaction for these two modes of service delivery; 4) Identify facilitators and barriers to the implementation of TELE-FOLLOW-UP. In order to meet the objectives of the study, mixed methods will be used. A randomized clinical trial will be used to achieve objectives 1, 2 and 3. The investigators plan to recruit 142 patients. Two groups will be formed: 1) TELE-FOLLOW-UP group: users who will receive follow-up by telerehabilitation; 2) PHONE-FOLLOW-UP group: those who will receive follow-up by a phone call.
Detailed description
Rational : The rehabilitation service offered at the Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS) for non-hospitalized patients is performed in outpatient clinics. However, the demand for this service far exceeds the supply, so the take-up time is very long. Recognizing the threatened short-term accessibility, this outpatient clinic has put in place an initial assessment for any service request. The goal is to conduct a preliminary assessment of the condition of the user to teach an exercise and education program. In addition, sporadic monitoring is recommended to promote the effectiveness of the intervention.
To date, the follow-up of this preliminary assessment is done by a phone call from the professional to the patient one month later. However, it is noted that this type of monitoring is not optimal for various reasons, in particular because of the absence of visual contact with the user to allow appropriate feedback from the professional on the exercise execution. In this context, the possibility of having a follow-up by a physiotherapist using telerehabilitation, an application of information technologies allowing a synchronous auditory and visual link, would be an innovative way of increasing the effectiveness of the intervention. This study therefore responds to the need to validate the feasibility and effectiveness of a telerehabilitation home monitoring program for users receiving a preliminary assessment while waiting for physiotherapist at the outpatient physiotherapy clinic. The results of this study will be relevant to clinicians and managers and will undeniably influence the provision of rehabilitation services.
Objectives: The specific objectives are as followed: 1) Evaluate the implementation of telerehabilitation monitoring (TELE-FOLLOW-UP); 2) Evaluate the effectiveness of TELE-FOLLOW-UP compared to the usual phone call; 3) Evaluate user satisfaction for these two modes of service delivery; 4) Identify facilitators and barriers to the implementation of TELE-FOLLOW-UP.
Methodology : In order to meet the objectives of the study, mixed methods will be used. A randomized clinical trial will be used to achieve objectives 1, 2 and 3. The investigators plan to recruit 142 patients. Two groups will be formed: 1) TELE-FOLLOW-UP group: users who will receive follow-up by telerehabilitation; 2) PHONE-FOLLOW-UP group: those who will receive follow-up by a phone call. In order to complete Objective 4, a qualitative exploratory and descriptive study will be conducted using individual interviews (clinicians and health care managers) and focus groups (participants).
The successful implementation of this project will bring a unique experience in Quebec of implementing telerehabilitation in a health care facility. The CIUSSS de l'Estrie-CHUS could become a leader in sharing its experience for large-scale implementation in Quebec. The application in orthopedic outpatient clinics may be generalized to other clientele by increasing accessibility to rehabilitation services for clients where accessibility is an issue
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phone follow-up | Other | Other: Phone call follow-upPhone follow-up initiated by the health care professional one month after the initial evaluation at the external rehabilitation clinic. |
| Telerehabilitation follow-up | Experimental | Other: Telerehabilitation follow-upTelerehabilitation follow-up initiated by the health care professional one month after the initial evaluation at the external rehabilitation clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- To present a non-urgent condition (status determined during the initial evaluation at the clinic)
- To be apt to understand simple statement
- To have access to internet at and possess an electronic tablet or a computer at
Key exclusion criteria (1 listed)
- Do not understand French or English
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 |
|---|---|---|
| Phone call follow-upA physical therapist made a phone call to the patient one month after his/her initial evaluation at the external rehabilitation clinic | Other | Phone follow-up |
| Telerehabilitation follow-upA physical therapist made a direct follow-up through telerehabilitation to the patient one month after his/her initial evaluation at the external rehabilitation clinic | Other | Telerehabilitation follow-up |
Primary outcome
Change in pain through time
Time frame: Day 0, 1 month
0-10 pain scale (0= no pain, 10 = worst pain)
3 secondary outcomes
Change in quality of life through time
Time frame: Day 0, 12 months
Direct and indirect costs related to intervention
Time frame: 12 months
Satisfaction with service received
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Derived from this study: PubMed 35142425Renard M, Gaboury I, Michaud F, Tousignant M. The acceptability of two remote monitoring modalities for patients waiting for services in a physiotherapy outpatient clinic. Musculoskeletal Care. 2022 Sep;20(3):616-624. doi: 10.1002/msc.1622. Epub 2022 Feb 10.
- 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.
Michel Tousignant principal investigator
Université de Sherbrooke
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone call follow-up and Telerehabilitation follow-up in people with Rehabilitation and Orthopedic Disorder, run by Université de Sherbrooke at 2 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 3 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: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain through time (time frame: Day 0, 1 month). 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 NCT03991858, 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 5 Oct 2021.