Effectiveness of the ARTH-e Application for Exercise Adherence in People With Knee Osteoarthritis : RCT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-14

Study Completion Date

2025-11-06

Brief Summary

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The aim of this study is to investigate the effectiveness of a smartphone-based e-health application (intervention group) compared with standard care (control group) in terms of changes in adherence in patients with knee osteoarthritis using the EARS questionnaire. In addition, other questionnaires presented in the appendix (KOOS, TSK, EPAP, EQ-5D-3L, pain) will be given to all patients in order to meet the secondary evaluation criteria.

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Detailed Description

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Knee osteoarthritis is the most common joint disease affecting the joint itself as well as the peri-articular structures in a global and progressive manner. It can affect all the joints of the body, with a predominance for those which undergo strong mechanical constraints such as the rachis, the hip or the knee. It is a chronic pathology correlated with age, since nearly one adult in two is affected by osteoarthritis.

Today, connected objects have taken a predominant place in the daily life of the majority of the population, including seniors. It is an object of communication and socialization as well as a major information tool. E-health applications are more and more numerous in the stores and are a tool for assistance, information and support already used in many fields. In the context of therapeutic education, it is a motivational tool that can accompany patients by adapting to their needs and progress compared to traditional self-exercise methods. Studies of the obstacles and levers for the use of smartphone applications in chronic pathologies such as low back pain support the development of this tool.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The investigators plan to conduct a multicenter, prospective, comparative, randomised trial (1:1). Participants will be randomized to one of two groups: control or experimental. In each group (control or experimental), each participant will be able to use the application for a period of 6 months.

* Control group: physician's advice with examples of self-exercise (knee osteoarthritis booklet) + prescription for 12 physiotherapy sessions + delivery of a GARMIN connected bracelet.
* Intervention group: download the application + adapted physical activity session with an APA/physiotherapist + delivery of the knee osteoarthritis booklet + prescription for 12 physiotherapy sessions + delivery of a GARMIN connected bracelet.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

The investigating physician who will carry out the inclusion visit will know the result of the randomization which will be carried out during the consultation. The second evaluator, who will carry out the end-of-study visit, will not know the patient's group. As a result, the assessment will be neutral and the second assessor will evaluate the patient without being influenced by the study group.

Study Groups

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Control

Standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental group

Standard care and participants use the ARTH-e application for 6 months

Group Type EXPERIMENTAL

Application ARTH-e

Intervention Type OTHER

The ARTH-e application must be downloaded via the PlayStore or Applestore platform on phone and/or tablet. Once the application has been downloaded, the patient must scan a QRcode sent by the CHU to anonymize the data.

Participants will have 6 months to use the application at their convenience.

Interventions

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Application ARTH-e

The ARTH-e application must be downloaded via the PlayStore or Applestore platform on phone and/or tablet. Once the application has been downloaded, the patient must scan a QRcode sent by the CHU to anonymize the data.

Participants will have 6 months to use the application at their convenience.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients aged between 40 and 85 years with uni or bilateral knee osteoarthritis according to EULAR (European League Against Rheumatism) criteria, symptomatic and diagnosed prior to inclusion by a specialist or not.
* Having an involvement of at least one knee.
* Own a smartphone or tablet running at least Android 5 or iOS 11.
* Able to give written consent to participate in the study.
* Beneficiary of a social security plan.

Exclusion Criteria

* pregnant or breast-feeding women Patients under legal protection measures (guardianship, curatorship or protection of the court)
* Patients who have undergone knee surgery (total or partial prosthesis, tibial transposition surgery, arthrodesis)
* Patients with inflammatory rheumatism
* Patients with neurological sequelae
* Contraindications to physical activity for medical reasons
* Patients with difficulties in understanding the French language
* Refusal to participate
* Patients who have already participated in the ARTH-e 2 study or who are already included in a research protocol that could influence the current protocol

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No