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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04750304
Acronym
ARTHe 2
Enrollment
32
Registered
2021-02-11
Start date
2022-01-31
Completion date
2022-07-07
Last updated
2022-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteo Arthritis Knee

Keywords

Osteoarthritis, Gonarthrosis, smarthpone application, e-Health

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.

Interventions

BEHAVIORALApplication ARTHe

Patient will use ARTHe Application for 3 months

Sponsors

Openium
CollaboratorUNKNOWN
Caleden
CollaboratorUNKNOWN
Innovatherm
CollaboratorINDUSTRY
BPIfrance
CollaboratorOTHER
University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Excercie adherence3 weeksMeasured with Exercice Adherence Rating Scale (EARS) on 5 point Likert scale, 0= totally agree, 5 = totally disagree

Secondary

MeasureTime frameDescription
Functional evaluation3 weeks, 6 weeks, 3 monthsCollected 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.
Satisfaction questionnaire3 monthsCollection 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.
Frequency of opening the application per weekFrom day 1 to 3 monthsCollection of application usage parameters in a codified manner
Frequency of opening the application with on exercice session per weekFrom day 1 to 3 monthsCollection of application usage parameters in a codified manner
Time spent on the application at each openingFrom day 1 to 3 monthsCollection of application usage parameters in a codified manner
Daily number of stepsFrom day 1 to 3 monthsCollection of intrinsic activity data for a subgroup using a connected bracelet Garmin in vivo 4, in a codified manner
Number of sessions carried out on a level before moving to the next levelFrom day 1 to 3 monthsCollection of application usage parameters in a codified manner
Pain with analogic visual scale3 weeks, 6 weeks, 3 monthsaverage pain of the 3 prior days, collected on phone interview with analogic visual scale (0 = no pain, 10 = maximum pain )
Rate of positive responses to questionnaires true / falseFrom day 1 to 3 monthsCollection of application usage parameters in a codified manner
Average weekly pain levelFrom day 1 to 3 monthsAverage pain level will be asked on the application at most twice a week. Collection of application usage parameters in a codified manner
Intensity of movementFrom day 1 to 3 monthsIntensity 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
Daily heart rateFrom day 1 to 3 monthsDaily average, minimum and maximum heart rate will be collected for a subgroup using a connected bracelet Garmin in vivo 4, in a codified
Daily heart variabilityFrom day 1 to 3 monthsCollection of intrinsic activity data for a subgroup using a connected bracelet Garmin in vivo 4, in a codified manner
Daily energy expenditure in caloriesFrom day 1 to 3 monthsDaily energy expenditure in calories will be collected for a subgroup using a connected bracelet Garmin in vivo 4, in a codified manner
Rating of exercice session (out of 5 stars)From day 1 to 3 monthsCollection of application usage parameters in a codified manner

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026