Evaluation of the Brakes and Levers on the Use of an E-health Application for Osteoarthritis Patients (ARTHe-1)

October 8, 2019 updated by: University Hospital, Clermont-Ferrand

Evaluation of the Brakes and Levers on the Use of an E-health Therapeutic Education 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.

Study Overview

Status

Completed

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Auvergne Rhône Alpes
      • Chaudes Aigues, Auvergne Rhône Alpes, France, 15110
        • Thermes CALEDEN - Société thermale de Chaudes Aigues
      • Clermont-Ferrand, Auvergne Rhône Alpes, France, 63000
        • CHU Gabriel Montpied
      • Royat, Auvergne Rhône Alpes, France, 63408
        • Thermes de ROYAT - Régie Municipale des eaux minérales de Royat / SPIC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients : Adult with osteoarthritis Healt professionnal : Health professionals in contact with arthrostic patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patient
patients with predominant osteoarthritis of the knees
Health professionals
health professionals with a link to osteoarthritis (physical and rehabilitation doctor, Rheumatologist, Physiotherapist, family doctor, pharmacist, Adapted physical activity teacher)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
socio-demographic questionnaire
Time Frame: Day 1
This questionnaire will help to categorized subjects in sub-group
Day 1
Measure of Kinesiophobia
Time Frame: Day 1
TSK (Tampa Scale of Kinesiophobia) scale will be used
Day 1
Measure of Knee injury
Time Frame: Day 1
KOOS (Knee injury and Osteoarthritis Outcome Score) scale will be used
Day 1
Measure of physical activity perception
Time Frame: Day 1
EPAP (Evaluation of perception of physical activity) scale will be used
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

August 31, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

October 8, 2019

First Submitted That Met QC Criteria

October 8, 2019

First Posted (Actual)

October 9, 2019

Study Record Updates

Last Update Posted (Actual)

October 9, 2019

Last Update Submitted That Met QC Criteria

October 8, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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