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

Osteo Arthritis Knee Clinical Trial

— ARTHe 2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04750304
• Other study ID #: RNI 2020 COUDEYRE
• Status: Completed
• Start date: January 31, 2022
• Est. completion date: July 7, 2022

Study information

• Verified date: February 2022
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 7, 2022
• Est. primary completion date: July 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Application ARTHe
Patient will use ARTHe Application for 3 months

Locations

Country	Name	City	State
France	Clermont-Ferrand University Hospital	Clermont-Ferrand	Aura

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	BPIfrance, Caleden, Innovatherm, Openium

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Excercie adherence	Measured with Exercice Adherence Rating Scale (EARS) on 5 point Likert scale, 0= totally agree, 5 = totally disagree	3 weeks
Primary	Excercie adherence	Measured with Exercice Adherence Rating Scale (EARS) on 5 point Likert scale, 0= totally agree, 5 = totally disagree	6 weeks
Primary	Excercie adherence	Measured with Exercice Adherence Rating Scale (EARS) on 5 point Likert scale, 0= totally agree, 5 = totally disagree	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Frequency of opening the application per week	Collection of application usage parameters in a codified manner	From day 1 to 3 months
Secondary	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
Secondary	Time spent on the application at each opening	Collection of application usage parameters in a codified manner	From day 1 to 3 months
Secondary	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
Secondary	Rating of exercice session (out of 5 stars)	Collection of application usage parameters in a codified manner	From day 1 to 3 months
Secondary	Rate of positive responses to questionnaires true / false	Collection of application usage parameters in a codified manner	From day 1 to 3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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