Evaluation of the Use of an E-health Therapeutic Education Application for Osteoarthritis Patients

Study Overview
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Brief Summary
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Osteoarthritis is the most common joint disease affecting the joint in a comprehensive and progressive manner. It leads to increasing disability. The recommendations of recent years favor the non-pharmacological treatment of osteoarthritis including regular physical activity, therapeutic education and weight loss Osteoarthritis population has a low level of physical activity due to a lack of information, motivation and false beliefs related to physical activity and kinesiophobia (fear of movement) A preliminary qualitative study (ARTHe1) evaluating the barriers and levers of the use of an e-health therapeutic education application in patients with osteoarthritis was carried out in order to guide the development of the ARTHe application. The objective of this study is to have the application tested on a panel of patients in order to assess the benefits of using the application in terms of adherence to the practice of physical activity but also in clinical terms on function and pain, and the satisfaction of the patient

Detailed Description
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This is a prospective observational study including the evaluation of the use of the ARTH-e application after 3 weeks, 6 weeks and 3 months of use. Patient recruitment will be done in the PRM department of Clermont-Ferrand University Hospital A subgroup of patients will receive a Garmin VivoSmart 4 connected wristband, which will record intrinsic stress measurement data during the test.

Official Title
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Evaluation of the Use of an E-health Therapeutic Education Application for Osteoarthritis Patients

Conditions
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Osteo Arthritis Knee

Intervention / Treatment
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* Behavioral: Application ARTHe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years Patients with osteoarthritis according to the ACR (American College of Rheumatology) criteria, symptomatic and diagnosed before inclusion by a specialist or not. Patients with least one knee impairment Patients with a smartphone or tablet with at least Android 5 or iOS 11. Volunteer patients willing to participate in the study. Exclusion Criteria: Patients with no diagnostic criteria for ACR. Patients with comprehension disorders making it impossible to interview and complete questionnaires or use the application. Refusal to participate or being already included in a research protocol that could influence the current protocol. Patients under guardianship, curatorship or deprived of liberty.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Application ARTHe|Patient will use ARTHe Application for 3 months|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excercie adherence | Measured with Exercice Adherence Rating Scale (EARS) on 5 point Likert scale, 0= totally agree, 5 = totally disagree | 3 weeks | 
| Excercie adherence | Measured with Exercice Adherence Rating Scale (EARS) on 5 point Likert scale, 0= totally agree, 5 = totally disagree | 6 weeks | 
| Excercie adherence | Measured with Exercice Adherence Rating Scale (EARS) on 5 point Likert scale, 0= totally agree, 5 = totally disagree | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain with analogic visual scale | average pain of the 3 prior days, collected on phone interview with analogic visual scale (0 = no pain, 10 = maximum pain ) | 3 weeks, 6 weeks, 3 months | 
| Functional evaluation | Collected on the phone with Knee injury and Osteoarthritis Outcome Score (KOOS). This questionnaire contains 17 statements answering the question During the last eight days, what was your difficulty with each of the following activities? . The responses range from absent (0 points) to extreme (4 points). The maximum score is 68. A high score is predictive of functional degradation. | 3 weeks, 6 weeks, 3 months | 
| Satisfaction questionnaire | Collection after 3 months of use, of the evaluation of the application via a quality questionnaire in 3 parts including the general user experience, closed questions on the user interface and open questions on user expectations, this questionnaire will be sent by email. | 3 months | 
| Frequency of opening the application per week | Collection of application usage parameters in a codified manner | From day 1 to 3 months | 
| Frequency of opening the application with on exercice session per week | Collection of application usage parameters in a codified manner | From day 1 to 3 months | 
| Time spent on the application at each opening | Collection of application usage parameters in a codified manner | From day 1 to 3 months | 
| Number of sessions carried out on a level before moving to the next level | Collection of application usage parameters in a codified manner | From day 1 to 3 months | 
| Rating of exercice session (out of 5 stars) | Collection of application usage parameters in a codified manner | From day 1 to 3 months | 
| Rate of positive responses to questionnaires true / false | Collection of application usage parameters in a codified manner | From day 1 to 3 months | 
| Average weekly pain level | Average pain level will be asked on the application at most twice a week. Collection of application usage parameters in a codified manner | From day 1 to 3 months | 
| Daily number of steps | Collection of intrinsic activity data for a subgroup using a connected bracelet Garmin in vivo 4, in a codified manner | From day 1 to 3 months | 
| Intensity of movement | Intensity of movement per day using Metbolic Equivalebt Task (MET) scale will be collected for a subgroup using a connected bracelet Garmin in vivo 4, in a codified manner | From day 1 to 3 months | 
| Daily heart rate | Daily average, minimum and maximum heart rate will be collected for a subgroup using a connected bracelet Garmin in vivo 4, in a codified | From day 1 to 3 months | 
| Daily heart variability | Collection of intrinsic activity data for a subgroup using a connected bracelet Garmin in vivo 4, in a codified manner | From day 1 to 3 months | 
| Daily energy expenditure in calories | Daily energy expenditure in calories will be collected for a subgroup using a connected bracelet Garmin in vivo 4, in a codified manner | From day 1 to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Gonarthrosis, smarthpone application, e-Health