- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07687836
Retrospective Evaluation of the Implementation of a Digital Solution Supporting the Delivery of Pulmonary Rehabilitation Programs in Private Physiotherapy Practice (DIGILIB-RR)
Pulmonary rehabilitation improves exercise capacity, functional status, symptoms and quality of life in individuals with chronic respiratory diseases. However, access to pulmonary rehabilitation remains limited due to insufficient availability of specialized centers and geographical, organizational, logistical, and financial barriers. Delivering pulmonary rehabilitation in private physiotherapy practices may improve access to care, but implementation can be challenged by limited resources, equipment, and support tools.
A field-based implementation program was conducted from summer 2025 to support physiotherapists in delivering pulmonary rehabilitation in private practice through the provision of a digital support solution (TELEREHAPP) and, where appropriate, associated equipment. During this program, physiotherapists collected data on solution use, patient characteristics, and available clinical follow-up indicators. Satisfaction and perceived usability were assessed among both physiotherapists and patients.
This retrospective study aims to analyze the data already collected during the implementation program to evaluate the feasibility of implementation, use, and acceptability of the TELEREHAPP digital solution in private physiotherapy practice, and to describe changes in available clinical outcomes among participating patients.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
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Rouen, France, 76000
- ADIR Association
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age superior to 18 years;
- Referred for pulmonary rehabilitation in private physiotherapy practice.
Non-inclusion Criteria:
- Not applicable
Exclusion Criteria:
- Not applicable
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Participants
Physiotherapists and patients with chronic respiratory diseases participating in a pulmonary rehabilitation program in a private physiotherapy practice using a digital solution (TELEREHAPP).
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Pulmonary rehabilitation supported by TELEREHAPP consisted of a program delivered in private physiotherapy practice using a digital health application designed to support the implementation, monitoring, and follow-up of rehabilitation and physical activity programs.
Depending on the physiotherapist's usual practice and the patient's needs, the program could include endurance exercise training, muscle strengthening, physical activity coaching, self-administered questionnaires, and individualized monitoring by the physiotherapist.
The digital solution was used as a support tool for care delivery and follow-up; the content, duration, frequency, and modalities of the program were determined by the treating physiotherapist.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Physiotherapist Adoption of the Digital Solution
Time Frame: 6 to 10 months
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Proportion of equipped physiotherapists who used the solution to support at least one patient during the experimentation period.
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6 to 10 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Physiotherapist Acceptance Rate
Time Frame: Baseline
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Proportion of contacted physiotherapists who agreed to be equipped with the digital solution.
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Baseline
|
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Number of Patients Managed
Time Frame: 6 to 10 months
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Total number of patients managed, number per physiotherapist, and number per physiotherapist per month.
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6 to 10 months
|
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Modules Used
Time Frame: 6 to 10 months
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Types of modules used within the digital solution (endurance training, muscle strengthening, physical activity coaching, self-administered questionnaires).
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6 to 10 months
|
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Number of Sessions Completed
Time Frame: 6 to 10 months
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Number of sessions completed for each module.
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6 to 10 months
|
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Program Duration
Time Frame: 6 to 10 months
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Duration of the proposed programs.
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6 to 10 months
|
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Program Frequency
Time Frame: 6 to 10 months
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Frequency of the proposed programs.
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6 to 10 months
|
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Physiotherapist Satisfaction
Time Frame: 6 to 10 months
|
Satisfaction of physiotherapists with the care pathway involving the digital solution, assessed using an adapted Client Satisfaction Questionnaire-8 items.
Scores therefore range from 8 to 32, with higher values indicating higher satisfaction.
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6 to 10 months
|
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Patient Satisfaction
Time Frame: 6 to 10 months
|
Satisfaction of patients with the care pathway involving the digital solution, assessed using the Client Satisfaction Questionnaire-8 items.
Scores therefore range from 8 to 32, with higher values indicating higher satisfaction.
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6 to 10 months
|
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Perceived Usability - Physiotherapists
Time Frame: 6 to 10 months
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Perceived usability of the digital solution by physiotherapists, assessed using the System Usability Scale.
Scores therefore range from 0 to 100, with higher values indicating higher satisfaction.
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6 to 10 months
|
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Perceived Usability - Patients
Time Frame: 6 to 10 months
|
Perceived usability of the digital solution by patients, assessed using the System Usability Scale.
Scores therefore range from 0 to 100, with higher values indicating higher satisfaction.
|
6 to 10 months
|
|
Exercise Capacity - 6-Minute Walk Distance
Time Frame: 8 to 10 weeks
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Exercise capacity will be assessed using the 6-Minute Walk Test (6MWT) before and after the rehabilitation program.
The test measures the distance walked in 6 minutes, expressed in meters, with higher values indicating greater exercise capacity.
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8 to 10 weeks
|
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Exercise Capacity - 6-Minute Stepper Test (6MST)
Time Frame: 8 to 10 weeks
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Exercise capacity will be assessed using the 6-Minute Stepper Test (6MST) before and after the rehabilitation program.
The outcome is the number of steps completed during the test over 6 minutes.
Higher values indicate better exercise capacity.
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8 to 10 weeks
|
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Exercise Capacity - 1-Minute Sit-to-Stand Test (1STS)
Time Frame: 8 to 10 weeks
|
Exercise capacity will be assessed using the 1-Minute Sit-to-Stand Test (1STS) before and after the rehabilitation program.
The test measures the number of sit-to-stand repetitions completed in 1 minute, with higher values indicating greater exercise capacity.
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8 to 10 weeks
|
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Health Status
Time Frame: 8 to 10 weeks
|
Health status will be assessed using the Chronic obstructive pulmonary disease Assessment Test (CAT) before and after the rehabilitation program and after 1 year of the enrollement date.
The score ranges from 0 to 40, with higher values indicating greater impairment of health status.
The established minimal clinically important difference for this questionnaire is -2.5 points.
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8 to 10 weeks
|
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Respiratory Quality of Life
Time Frame: 8 to 10 weeks
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Assessed using the Visual Simplified Respiratory Questionnaire (VSRQ).
The score ranges from 0 to 80, with higher values indicating greater quality of life.
The established minimal clinically important difference for this questionnaire is 3.4 points.
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8 to 10 weeks
|
|
Psychological Status - Anxiety
Time Frame: 8 to 10 weeks
|
Symptoms of anxiety will be assessed using the Hospital Anxiety and Depression questionnaire, anxiety subscore, before and after the rehabilitation program and after 1 year of the enrollement date.
The score ranges from 0 (best) to 21 (worst).
The pre-specified minimal clinically important difference is set at -1.5 point.
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8 to 10 weeks
|
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Psychological Status - Depression
Time Frame: 8 to 10 weeks
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Symptoms of anxiety will be assessed using the Hospital Anxiety and Depression questionnaire, anxiety subscore, before and after the rehabilitation program and after 1 year of the enrollement date.
The score ranges from 0 (best) to 21 (worst).
The pre-specified minimal clinically important difference is set at -1.5 point.
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8 to 10 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tristan Bonnevie, ADIR Association
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DIGILIB-RR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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