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Osteo Arthritis KneeARTHe 2NCT04750304

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

An observational study of Osteo Arthritis Knee, run by University Hospital, Clermont-Ferrand at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteo Arthritis Knee
What is being tested?
Application ARTHe
How many people
32 participants
Where
1 siteFrance
Study dates
31 Jan 2022to 7 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patient with knee arthritis and using a smartphone

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Clermont-Ferrand University Hospital

    Clermont-Ferrand, AURA, 63000

Other trials in France

About this study

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

Read the 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.

Being tested
Application ARTHe
Keywords
Osteoarthritis, Gonarthrosis, smarthpone application, e-Health
Medical subject headings
Osteoarthritis, Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Application ARTHeBehavioural

    Patient will use ARTHe Application for 3 months

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Excercie adherence

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

    Measured: 3 weeks

  2. Excercie adherence

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

    Measured: 6 weeks

  3. Excercie adherence

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

    Measured: 3 months

Secondary outcomes (15)

  1. 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 )

    Measured: 3 weeks, 6 weeks, 3 months

  2. 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.

    Measured: 3 weeks, 6 weeks, 3 months

  3. 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.

    Measured: 3 months

  4. Frequency of opening the application per week

    Collection of application usage parameters in a codified manner

    Measured: From day 1 to 3 months

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

    Collection of application usage parameters in a codified manner

    Measured: From day 1 to 3 months

  6. Time spent on the application at each opening

    Collection of application usage parameters in a codified manner

    Measured: From day 1 to 3 months

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

    Collection of application usage parameters in a codified manner

    Measured: From day 1 to 3 months

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

    Collection of application usage parameters in a codified manner

    Measured: From day 1 to 3 months

  9. Rate of positive responses to questionnaires true / false

    Collection of application usage parameters in a codified manner

    Measured: From day 1 to 3 months

  10. 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

    Measured: From day 1 to 3 months

  11. Daily number of steps

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

    Measured: From day 1 to 3 months

  12. 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

    Measured: From day 1 to 3 months

  13. 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

    Measured: From day 1 to 3 months

  14. Daily heart variability

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

    Measured: From day 1 to 3 months

  15. 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

    Measured: From day 1 to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2021
  2. Study start31 Jan 2022
  3. Primary completion7 Jul 2022
  4. Study completion7 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04750304
Sponsor's protocol ID
RNI 2020 COUDEYRE
Acronym
ARTHe 2
Status last verified
Feb 2022
First submitted
10 Feb 2021
Last updated
11 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Osteo Arthritis Knee, run by University Hospital, Clermont-Ferrand at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Excercie adherence (time frame: 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04750304.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.

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