NCT04120727

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2019

Completed
Last Updated

October 9, 2019

Status Verified

July 1, 2019

Enrollment Period

2 months

First QC Date

October 8, 2019

Last Update Submit

October 8, 2019

Conditions

Keywords

OsteoarthritiseHealththerapeutic educationConnected objects

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • socio-demographic questionnaire

    Day 1

  • Measure of Kinesiophobia

    Day 1

  • Measure of Knee injury

    Day 1

  • Measure of physical activity perception

    Day 1

Study Arms (2)

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)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Thermes CALEDEN - Société thermale de Chaudes Aigues

Chaudes-Aigues, Auvergne-Rhône-Alpes, 15110, France

Location

CHU Gabriel Montpied

Clermont-Ferrand, Auvergne-Rhône-Alpes, 63000, France

Location

Thermes de ROYAT - Régie Municipale des eaux minérales de Royat / SPIC

Royat, Auvergne-Rhône-Alpes, 63408, France

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2019

First Posted

October 9, 2019

Study Start

July 1, 2019

Primary Completion

August 31, 2019

Study Completion

September 30, 2019

Last Updated

October 9, 2019

Record last verified: 2019-07

Locations