- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04120727
Evaluation of the Brakes and Levers on the Use of an E-health Application for Osteoarthritis Patients (ARTHe-1)
Evaluation of the Brakes and Levers on the Use of an E-health Therapeutic Education Application for Osteoarthritis Patients
Osteoarthritis is the most common articular disease affecting the joint in a comprehensive and progressive manner. It is a chronic pathology correlated with age since nearly one in two adults is affected by osteoarthritis. The care of osteoarthritis is based on pharmacological and non-pharmacological treatment. The latest recommendations support the non-pharmacological part including regular physical activity, therapeutic education and weight loss. Today tools are lacking for the patient and the practitioner to ensure long-term motivation and support.
Connected objects, as future-oriented tools, are a customizable way to meet the expectations of both patients and professionals. The main objective of this study is to analyze the expectations regarding the use of a smartphone application for monitoring and support in the practice of exercises and regular physical activity in patients osteoarthritic.
The secondary objective is to collect information on the use of connected objects dedicated to the management of osteoarthritis by patients and health professionals.
Study Overview
Status
Conditions
Detailed Description
This study is aimed at patients with predominant knee osteoarthritis and health professionals with a link to the pathology.
A semi-directed interview according to a pre-established interview guide will be performed. Interviews are conducted by trained professionals and recorded with a dictaphone. Self-questionnaires are submitted to the patient after the interview.
The recordings are transcribed as quickly as possible in text format. The verbatim will then be coded (axial coding) then grouped by categories and then by themes.
The objective is to determine the expectations of patients and health professionals regarding a smartphone application dedicated to osteoarthritis.
This study will serve as a basis for designing a tool of this type to improve the long-term management of osteoarthritis.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Auvergne Rhône Alpes
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Chaudes Aigues, Auvergne Rhône Alpes, France, 15110
- Thermes CALEDEN - Société thermale de Chaudes Aigues
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Clermont-Ferrand, Auvergne Rhône Alpes, France, 63000
- CHU Gabriel Montpied
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Royat, Auvergne Rhône Alpes, France, 63408
- Thermes de ROYAT - Régie Municipale des eaux minérales de Royat / SPIC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria for Patient :
- Patient with osteoarthritis according to the criteria of the ACR (American College of Rheumatology), symptomatic and diagnosed in advance of inclusion by a specialist physician or not
Inclusion Criteria for Professional :
-Selected health professionals must be in practice at the time of inclusion. General practitioners, MPR (Physical and Rehabilitation Medicine), rheumatologists, physiotherapists, APA (Professor of Adapted Physical Activity) and pharmacists caring for arthrosic patients, either salaried or liberal and on the volunteering base.
Exclusion Criteria:
- Patients who do not meet the diagnostic criteria of the ACR (American College of Rheumatology)
- Patients with comprehension disorders which make it impossible to maintain and fill out questionnaires.
- Refusal to participate or already included in a therapeutic education workshop.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Patient
patients with predominant osteoarthritis of the knees
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Health professionals
health professionals with a link to osteoarthritis (physical and rehabilitation doctor, Rheumatologist, Physiotherapist, family doctor, pharmacist, Adapted physical activity teacher)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brakes and levers on the use of an e-health therapeutic education tool for arthrosic patients
Time Frame: Day 1
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A qualitative study that aims to target expectations of an e-health therapeutic education application.
An interview (individual semi-directed interview method) is scheduled to be conducted with patients and practitioners lasting 20 to 40 minutes.
This interview is divided into 3 items: daily physical activity, opinion on connected objects dedicated to health, key points that should be included in the application
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
socio-demographic questionnaire
Time Frame: Day 1
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This questionnaire will help to categorized subjects in sub-group
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Day 1
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Measure of Kinesiophobia
Time Frame: Day 1
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TSK (Tampa Scale of Kinesiophobia) scale will be used
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Day 1
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Measure of Knee injury
Time Frame: Day 1
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KOOS (Knee injury and Osteoarthritis Outcome Score) scale will be used
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Day 1
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Measure of physical activity perception
Time Frame: Day 1
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EPAP (Evaluation of perception of physical activity) scale will be used
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Day 1
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019 ARTHe-1
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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