A Study to Evaluate Efficacy and Safety of AMZ001 for the Treatment of Knee Osteoarthritis Symptoms
NCT06693648
Arthritis, Joint Diseases
Thousand Oaks, California, United States
View Trial DetailsNCT Number: NCT04120727
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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Notify Me18 year and older
All sexes
Observational
Thermes CALEDEN - Société thermale de Chaudes Aigues, Chaudes-Aigues, Auvergne-Rhône-Alpes, France
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Patient :
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
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
Time frame: Day 1
This questionnaire will help to categorized subjects in sub-group
Time frame: Day 1
TSK (Tampa Scale of Kinesiophobia) scale will be used
Time frame: Day 1
KOOS (Knee injury and Osteoarthritis Outcome Score) scale will be used
Time frame: Day 1
EPAP (Evaluation of perception of physical activity) scale will be used
University Hospital, Clermont-Ferrand
Other
Evaluation of the Brakes and Levers on the Use of an E-health Therapeutic Education Application for Osteoarthritis Patients
Acronym: ARTHe-1
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