Clinical trial NCT04750304: Evaluation of the Use of an E-health Therapeutic Education Application for Osteoarthritis Patients
Official title: Evaluation of the Use of an E-health Therapeutic Education Application for Osteoarthritis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteo Arthritis Knee
Keywords: Osteoarthritis
Gonarthrosis
smarthpone application
e-Health
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Openium
name: Caleden
name: Innovatherm
name: BPIfrance
First posted: 2021-02-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with knee arthritis and using a smartphone

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Excercie adherence
timeFrame: 3 weeks
measure: Excercie adherence
timeFrame: 6 weeks
measure: Excercie adherence
timeFrame: 3 months
Secondary outcomes:
measure: Pain with analogic visual scale
timeFrame: 3 weeks, 6 weeks, 3 months
measure: Functional evaluation
timeFrame: 3 weeks, 6 weeks, 3 months
measure: Satisfaction questionnaire
timeFrame: 3 months
measure: Frequency of opening the application per week
timeFrame: From day 1 to 3 months
measure: Frequency of opening the application with on exercice session per week
timeFrame: From day 1 to 3 months
measure: Time spent on the application at each opening
timeFrame: From day 1 to 3 months
measure: Number of sessions carried out on a level before moving to the next level
timeFrame: From day 1 to 3 months
measure: Rating of exercice session (out of 5 stars)
timeFrame: From day 1 to 3 months
measure: Rate of positive responses to questionnaires true / false
timeFrame: From day 1 to 3 months
measure: Average weekly pain level
timeFrame: From day 1 to 3 months
measure: Daily number of steps
timeFrame: From day 1 to 3 months
measure: Intensity of movement
timeFrame: From day 1 to 3 months
measure: Daily heart rate
timeFrame: From day 1 to 3 months
measure: Daily heart variability
timeFrame: From day 1 to 3 months
measure: Daily energy expenditure in calories
timeFrame: From day 1 to 3 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
state: Aura
Study officials:
References: