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

Osteoarthritis, Knee Clinical Trial

— ARTHe-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04120727
• Other study ID #: 2019 ARTHe-1
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: July 2019
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 30, 2019
• Est. primary completion date: August 31, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Locations

Country	Name	City	State
France	Thermes CALEDEN - Société thermale de Chaudes Aigues	Chaudes Aigues	Auvergne Rhône Alpes
France	CHU Gabriel Montpied	Clermont-Ferrand	Auvergne Rhône Alpes
France	Thermes de ROYAT - Régie Municipale des eaux minérales de Royat / SPIC	Royat	Auvergne Rhône Alpes

Sponsors (6)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	BPI France, Innovatherm, La région Auvergne-Rhône-Alpes, les thermes de Caleden, Les thermes de Royat

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brakes and levers on the use of an e-health therapeutic education tool for arthrosic patients	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	socio-demographic questionnaire	This questionnaire will help to categorized subjects in sub-group	Day 1
Secondary	Measure of Kinesiophobia	TSK (Tampa Scale of Kinesiophobia) scale will be used	Day 1
Secondary	Measure of Knee injury	KOOS (Knee injury and Osteoarthritis Outcome Score) scale will be used	Day 1
Secondary	Measure of physical activity perception	EPAP (Evaluation of perception of physical activity) scale will be used	Day 1