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

NCT04750304 | Completed

• 1 other identifier: RNI 2020 COUDEYRE
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Osteo Arthritis Knee

Keywords

Osteoarthritis; Gonarthrosis; smarthpone application; e-Health

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (15)

• Pain with analogic visual scale

  3 weeks, 6 weeks, 3 months

• Functional evaluation

  3 weeks, 6 weeks, 3 months

• Satisfaction questionnaire

  3 months

• Frequency of opening the application per week

  From day 1 to 3 months

• Frequency of opening the application with on exercice session per week

  From day 1 to 3 months

Interventions

Application ARTHe BEHAVIORAL

Patient will use ARTHe Application for 3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with knee arthritis and using a smartphone

You may qualify if:

• Patients older than 18 years
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Openium: collaborator
• Caleden: collaborator
• Innovatherm: collaborator
• BPIfrance: collaborator

Study Sites (1)

Clermont-Ferrand University Hospital

Clermont-Ferrand, AURA, 63000, France

Location

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 11, 2021
• Study Start: January 31, 2022
• Primary Completion: July 7, 2022
• Study Completion: July 7, 2022
• Last Updated: July 11, 2022

Record last verified: 2022-02

Locations

FR (1)