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NCT Number: NCT04120727

Evaluation of the Brakes and Levers on the Use of an E-health Application for Osteoarthritis Patients

Osteoarthritis is the most common articular disease affecting the joint in a comprehensive and progressive manner. It is a chronic pathology correlated with age since nearly one in two adults is affected by osteoarthritis. The care of osteoarthritis is based on pharmacological and non-pharmacological treatment. The latest recommendations support the non-pharmacological part including regular physical activity, therapeutic education and weight loss. Today tools are lacking for the patient and the practitioner to ensure long-term motivation and support.

Connected objects, as future-oriented tools, are a customizable way to meet the expectations of both patients and professionals. The main objective of this study is to analyze the expectations regarding the use of a smartphone application for monitoring and support in the practice of exercises and regular physical activity in patients osteoarthritic.

The secondary objective is to collect information on the use of connected objects dedicated to the management of osteoarthritis by patients and health professionals.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Thermes CALEDEN - Société thermale de Chaudes Aigues, Chaudes-Aigues, Auvergne-Rhône-Alpes, France

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About this study

This study is aimed at patients with predominant knee osteoarthritis and health professionals with a link to the pathology.

A semi-directed interview according to a pre-established interview guide will be performed. Interviews are conducted by trained professionals and recorded with a dictaphone. Self-questionnaires are submitted to the patient after the interview.

The recordings are transcribed as quickly as possible in text format. The verbatim will then be coded (axial coding) then grouped by categories and then by themes.

The objective is to determine the expectations of patients and health professionals regarding a smartphone application dedicated to osteoarthritis.

This study will serve as a basis for designing a tool of this type to improve the long-term management of osteoarthritis.

Who can participate

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

Inclusion criteria

for Patient :

  • Patient with osteoarthritis according to the criteria of the ACR (American College of Rheumatology), symptomatic and diagnosed in advance of inclusion by a specialist physician or not

Inclusion criteria

for Professional :

-Selected health professionals must be in practice at the time of inclusion. General practitioners, MPR (Physical and Rehabilitation Medicine), rheumatologists, physiotherapists, APA (Professor of Adapted Physical Activity) and pharmacists caring for arthrosic patients, either salaried or liberal and on the volunteering base.

Exclusion criteria

  • Patients who do not meet the diagnostic criteria of the ACR (American College of Rheumatology)
  • Patients with comprehension disorders which make it impossible to maintain and fill out questionnaires.
  • Refusal to participate or already included in a therapeutic education workshop.

Treatment and study plan

Primary outcomes

  1. Brakes and levers on the use of an e-health therapeutic education tool for arthrosic patients

    Time frame: Day 1

    A qualitative study that aims to target expectations of an e-health therapeutic education application. An interview (individual semi-directed interview method) is scheduled to be conducted with patients and practitioners lasting 20 to 40 minutes. This interview is divided into 3 items: daily physical activity, opinion on connected objects dedicated to health, key points that should be included in the application

Secondary outcomes

  1. socio-demographic questionnaire

    Time frame: Day 1

    This questionnaire will help to categorized subjects in sub-group

  2. Measure of Kinesiophobia

    Time frame: Day 1

    TSK (Tampa Scale of Kinesiophobia) scale will be used

  3. Measure of Knee injury

    Time frame: Day 1

    KOOS (Knee injury and Osteoarthritis Outcome Score) scale will be used

  4. Measure of physical activity perception

    Time frame: Day 1

    EPAP (Evaluation of perception of physical activity) scale will be used

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • BPIfrance
  • Innovatherm
  • La région Auvergne-Rhône-Alpes
  • Les thermes de Royat
  • les thermes de Caleden

Registry information

Official study title

Evaluation of the Brakes and Levers on the Use of an E-health Therapeutic Education Application for Osteoarthritis Patients

Acronym: ARTHe-1

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 9, 2019
Registry last updated
Oct 9, 2019

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.

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