Skip to main content
OpenTrials
Completed

NCT Number: NCT04750304

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteo Arthritis Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clermont-Ferrand University Hospital

Clermont-Ferrand, AURA, 63000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Application ARTHe

Behavioral

Patient will use ARTHe Application for 3 months

Primary outcomes

  1. Excercie adherence

    Time frame: 3 weeks

    Measured with Exercice Adherence Rating Scale (EARS) on 5 point Likert scale, 0= totally agree, 5 = totally disagree

  2. Excercie adherence

    Time frame: 6 weeks

    Measured with Exercice Adherence Rating Scale (EARS) on 5 point Likert scale, 0= totally agree, 5 = totally disagree

  3. Excercie adherence

    Time frame: 3 months

    Measured with Exercice Adherence Rating Scale (EARS) on 5 point Likert scale, 0= totally agree, 5 = totally disagree

Secondary outcomes

  1. Pain with analogic visual scale

    Time frame: 3 weeks, 6 weeks, 3 months

    average pain of the 3 prior days, collected on phone interview with analogic visual scale (0 = no pain, 10 = maximum pain )

  2. Functional evaluation

    Time frame: 3 weeks, 6 weeks, 3 months

    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. Satisfaction questionnaire

    Time frame: 3 months

    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.

  4. Frequency of opening the application per week

    Time frame: From day 1 to 3 months

    Collection of application usage parameters in a codified manner

  5. Frequency of opening the application with on exercice session per week

    Time frame: From day 1 to 3 months

    Collection of application usage parameters in a codified manner

  6. Time spent on the application at each opening

    Time frame: From day 1 to 3 months

    Collection of application usage parameters in a codified manner

  7. Number of sessions carried out on a level before moving to the next level

    Time frame: From day 1 to 3 months

    Collection of application usage parameters in a codified manner

  8. Rating of exercice session (out of 5 stars)

    Time frame: From day 1 to 3 months

    Collection of application usage parameters in a codified manner

  9. Rate of positive responses to questionnaires true / false

    Time frame: From day 1 to 3 months

    Collection of application usage parameters in a codified manner

  10. Average weekly pain level

    Time frame: From day 1 to 3 months

    Average pain level will be asked on the application at most twice a week. Collection of application usage parameters in a codified manner

  11. Daily number of steps

    Time frame: From day 1 to 3 months

    Collection of intrinsic activity data for a subgroup using a connected bracelet Garmin in vivo 4, in a codified manner

  12. Intensity of movement

    Time frame: From day 1 to 3 months

    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

  13. Daily heart rate

    Time frame: From day 1 to 3 months

    Daily average, minimum and maximum heart rate will be collected for a subgroup using a connected bracelet Garmin in vivo 4, in a codified

  14. Daily heart variability

    Time frame: From day 1 to 3 months

    Collection of intrinsic activity data for a subgroup using a connected bracelet Garmin in vivo 4, in a codified manner

  15. Daily energy expenditure in calories

    Time frame: From day 1 to 3 months

    Daily energy expenditure in calories will be collected for a subgroup using a connected bracelet Garmin in vivo 4, in a codified manner

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • BPIfrance
  • Caleden
  • Innovatherm
  • Openium

Registry information

Acronym: ARTHe 2

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 11, 2021
Registry last updated
Jul 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.