Implementation of Telerehabilitation as Modality of Patient Follow-up on the Waiting List of a Clinic

September 27, 2021 updated by: Michel Tousignant, Université de Sherbrooke

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
142

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Sherbrooke, Canada
        • Research Centre on Aging
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 4C4
        • Research Center on Aging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Do not understand French or English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Phone follow-up
Phone follow-up initiated by the health care professional one month after the initial evaluation at the external rehabilitation clinic.
Other: Phone call follow-up
A physical therapist made a phone call to the patient one month after his/her initial evaluation at the external rehabilitation clinic
Experimental: Telerehabilitation follow-up
Telerehabilitation follow-up initiated by the health care professional one month after the initial evaluation at the external rehabilitation clinic.
Other: Telerehabilitation follow-up
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in pain through time
Time Frame: Day 0, 1 month
0-10 pain scale (0= no pain, 10 = worst pain)
Day 0, 1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in quality of life through time
Time Frame: Day 0, 12 months
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.
Day 0, 12 months
Direct and indirect costs related to intervention
Time Frame: 12 months
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.
12 months
Satisfaction with service received
Time Frame: 1 month

Questionnaire about satisfaction of health care received. The satisfaction construct is determined by three distinct factors which include satisfaction with:

1) 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)
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Université de Sherbrooke

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministère de l'Économie, de la Science et de l'Innovation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michel Tousignant, Université de Sherbrooke

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 2, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 22, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-2919

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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