Osteoarthritis, KneeARTHe-1NCT04120727
Evaluation of the Brakes and Levers on the Use of an E-health Application for Osteoarthritis Patients
An observational study of Osteoarthritis, Knee, run by University Hospital, Clermont-Ferrand at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- How many people
- 32 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Jul 2019to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients : Adult with osteoarthritis Healt professionnal : Health professionals in contact with arthrostic patients
Who may be able to join
- 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
- -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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Thermes CALEDEN - Société thermale de Chaudes Aigues
Chaudes-Aigues, Auvergne-Rhône-Alpes, 15110
CHU Gabriel Montpied
Clermont-Ferrand, Auvergne-Rhône-Alpes, 63000
Thermes de ROYAT - Régie Municipale des eaux minérales de Royat / SPIC
Royat, Auvergne-Rhône-Alpes, 63408
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, eHealth, therapeutic education, Connected objects
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (4)
socio-demographic questionnaire
This questionnaire will help to categorized subjects in sub-group
Measured: Day 1
Measure of Kinesiophobia
TSK (Tampa Scale of Kinesiophobia) scale will be used
Measured: Day 1
Measure of Knee injury
KOOS (Knee injury and Osteoarthritis Outcome Score) scale will be used
Measured: Day 1
Measure of physical activity perception
EPAP (Evaluation of perception of physical activity) scale will be used
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start1 Jul 2019
- Primary completion31 Aug 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- BPIfrance, Innovatherm, La région Auvergne-Rhône-Alpes, les thermes de Caleden, Les thermes de Royat
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120727
- Sponsor's protocol ID
- 2019 ARTHe-1
- Acronym
- ARTHe-1
- Status last verified
- Jul 2019
- First submitted
- 8 Oct 2019
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Brakes and Levers on the Use of an E-health Therapeutic Education Application for Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT04120727
- Acronym / sponsor ID
- ARTHe-1 / 2019 ARTHe-1
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, eHealth, therapeutic education, Connected objects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- BPIfrance, Innovatherm, La région Auvergne-Rhône-Alpes, les thermes de Caleden, Les thermes de Royat
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients : Adult with osteoarthritis Healt professionnal : Health professionals in contact with arthrostic patients
Key inclusion criteria (2 listed)
- 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
- -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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
socio-demographic questionnaire
Time frame: Day 1
Measure of Kinesiophobia
Time frame: Day 1
Measure of Knee injury
Time frame: Day 1
Measure of physical activity perception
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by University Hospital, Clermont-Ferrand at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brakes and levers on the use of an e-health therapeutic education tool for arthrosic patients (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.