Arthritis, RheumatoidMAINTAINNCT03754855
Impact of Behavioral Factors on Treatment Adherence in a Sample of Rheumatoid Arthritis Patients
An observational study of Arthritis, Rheumatoid, run by University Hospital, Bordeaux at 5 sites in France.
Trial summary
Rheumatoid arthritis (RA) care has been revolutionized in the last decade with the advent of biotherapies. Only 66% of treated patients are compliant. Nevertheless, studies analyzing the medication adherence in RA are rare. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 590 participants
- Where
- 5 sitesFrance
- Study dates
- 28 Nov 2018to 10 Jul 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
- No healthy volunteers
- Adult, Older adult
Study population: Patient aged over 18 years old, affected by RA according to ACR/EULAR 2010 criteria
Who may be able to join
- patient aged over 18 years old,
- affected by RA according to ACR/EULAR 2010 criteria,
- francophone,
- and informed about the aims of the study.
Who cannot join
- guardianship patient,
- patient who refuses to participate.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU de Bordeaux - service de rhumatologie
Bordeaux
Service de Rhumatologie
Clermont-Ferrand
Service de rhumatologie
Limoges
Service de rhumatologie
Montpellier
Service de Rhumatologie
Toulouse
About this study
Rheumatoid arthritis (RA) care has been revolutionized in the last decade with the advent of biotherapies. Only 66% of treated patients are compliant. Nevertheless, studies analyzing the medication adherence in RA are rare. The aim of this study is thus to evaluate RA treatment adherence considering demographic data, vaccination coverage, feeding behavior and the use of e-health tools.
Read the detailed description
Rheumatoid arthritis (RA) care has been revolutionized in the last decade with the advent of biotherapies. The success of this therapeutic strategy is based on several factors, including the medication adherence. Whatever the method used, adherence evaluation is not sufficient, around 66% of the treated patients. Nevertheless, studies analysing the predictive factors of medication adherence in RA are rare.
RA patients are also educated about the infectious risk related to RA and treatments, and the importance of vaccination. These recommendations are not always respected by the patients, without knowing the exact factors leading to this decision. Furthermore, a lot of patients take personal initiatives without the agreement and the help of their practitioner, like diets or special feeding behaviors. Lastly, plenty of patients affected bv chronic diseases claim and use electronic health tools without any real evidence of the efficacy of such device.
The aim of this study is thus to evaluate RA treatment adherence considering demographic data, vaccination coverage, feeding behavior and the use of e-health tools.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Questionnaire
- Keywords
- Rheumatoid arthritis, medication adherence, vaccination coverage, electronic health tools, diet
- Medical subject headings
- Arthritis, Rheumatoid, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid Arthritis patients | patients affected by RA according to ACR/EULAR 2010 criteria Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who presented a good medication adherence according to the medication adherence questionnaire
Measured: At baseline (day 0)
Secondary outcomes (25)
Proportion of patients vaccinated against influenza and pneumococcal bacteria
Measured: At baseline (day 0)
Proportion of reasons of non-vaccination, globally and for each type of vaccination.
Measured: At baseline (day 0)
Proportion of factors influencing rheumatologists to propose vaccination.
Measured: At baseline (day 0)
Proportion of vaccinated patients who present a good medication adherence to RA specific therapies
Measured: At baseline (day 0)
Proportion of patients using electronic health tools
Measured: At baseline (day 0)
Proportion of patients using electronic health tools who present a good medication adherence to RA specific therapies
Measured: At baseline (day 0)
Proportion of patients with a special diet, globally and by type of diet
Measured: At baseline (day 0)
Proportion of patients presenting functional bowel disorder
Measured: At baseline (day 0)
Proportion of patients with a special diet who present a good medication adherence to RA specific therapies
Measured: At baseline (day 0)
Number of patients with a good medication adherence, according to age
Medication adherence will be evaluated with medication adherence questionnaires
Measured: At baseline (day 0)
Number of patients with a good medication adherence, according to gender
Medication adherence will be evaluated with medication adherence questionnaires
Measured: At baseline (day 0)
Number of patients with a good medication adherence, according to socio-professional category
Medication adherence will be evaluated with medication adherence questionnaires
Measured: At baseline (day 0)
Number of patients with a good medication adherence, according to educational level
Medication adherence will be evaluated with medication adherence questionnaires
Measured: At baseline (day 0)
Number of patients with a good medication adherence, according to involvement in a patients association
Medication adherence will be evaluated with medication adherence questionnaires
Measured: At baseline (day 0)
Number of patients with a good medication adherence, according to alcohol and/or tobacco consumption
Medication adherence will be evaluated with medication adherence questionnaires
Measured: At baseline (day 0)
Number of patients with a good medication adherence, according to disease duration
Medication adherence will be evaluated with medication adherence questionnaires
Measured: At baseline (day 0)
Number of patients with a good medication adherence, according to rheumatoid factor and/or ACPA positivity
Medication adherence will be evaluated with medication adherence questionnaires
Measured: At baseline (day 0)
Number of patients with a good medication adherence, according to DAS28 score levels
Medication adherence will be evaluated with medication adherence questionnaires
Measured: At baseline (day 0)
Number of patients with a good medication adherence, according to actual RA treatments
Medication adherence will be evaluated with medication adherence questionnaires
Measured: At baseline (day 0)
Number of patients with a good medication adherence, according to the use of alternative therapies (acupuncture and/or sophrology).
Medication adherence will be evaluated with medication adherence questionnaires
Measured: At baseline (day 0)
Number of patients for each personality trait category
Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire.
Measured: At baseline (day 0)
Number of patients with a good medication adherence, according to each personality trait category
Medication adherence will be evaluated with medication adherence questionnaires. Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire.
Measured: At baseline (day 0)
Number of patients with a vaccination coverage, according to each personality trait category.
Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire.
Measured: At baseline (day 0)
Number of patients with a special diet, according to each personality trait category
Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire
Measured: At baseline (day 0)
Number of patients using electronic health tools, according to each personality trait category
Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire
Measured: At baseline (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start28 Nov 2018
- Primary completion10 Jul 2019
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 590 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Association Aquitaine de Recherche Clinique en Rhumatologie
- Responsible party
- Sponsor
- Investigators
- Marie-Elise TRUCHETET, MD, PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754855
- Sponsor's protocol ID
- CHUBX 2018/07
- Acronym
- MAINTAIN
- Status last verified
- Jun 2020
- First submitted
- 19 Nov 2018
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Behavioral Factors on Treatment Adherence in a Sample of Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT03754855
- Acronym / sponsor ID
- MAINTAIN / CHUBX 2018/07
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Rheumatoid arthritis, medication adherence, vaccination coverage, electronic health tools, diet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 590 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Association Aquitaine de Recherche Clinique en Rhumatologie
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 27 Nov 2018 (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.
Rheumatoid arthritis (RA) care has been revolutionized in the last decade with the advent of biotherapies. Only 66% of treated patients are compliant. Nevertheless, studies analyzing the medication adherence in RA are rare. The aim of this study is thus to evaluate RA treatment adherence considering demographic data, vaccination coverage, feeding behavior and the use of e-health tools.
Detailed description
Rheumatoid arthritis (RA) care has been revolutionized in the last decade with the advent of biotherapies. The success of this therapeutic strategy is based on several factors, including the medication adherence. Whatever the method used, adherence evaluation is not sufficient, around 66% of the treated patients. Nevertheless, studies analysing the predictive factors of medication adherence in RA are rare.
RA patients are also educated about the infectious risk related to RA and treatments, and the importance of vaccination. These recommendations are not always respected by the patients, without knowing the exact factors leading to this decision. Furthermore, a lot of patients take personal initiatives without the agreement and the help of their practitioner, like diets or special feeding behaviors. Lastly, plenty of patients affected bv chronic diseases claim and use electronic health tools without any real evidence of the efficacy of such device.
The aim of this study is thus to evaluate RA treatment adherence considering demographic data, vaccination coverage, feeding behavior and the use of e-health tools.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis patients | – | Behavioral: Questionnairepatients affected by RA according to ACR/EULAR 2010 criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient aged over 18 years old, affected by RA according to ACR/EULAR 2010 criteria
Key inclusion criteria (4 listed)
- patient aged over 18 years old,
- affected by RA according to ACR/EULAR 2010 criteria,
- francophone,
- and informed about the aims of the study.
Key exclusion criteria (2 listed)
- guardianship patient,
- patient who refuses to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuestionnaire | Behavioural | Rheumatoid Arthritis patients |
Primary outcome
Proportion of patients who presented a good medication adherence according to the medication adherence questionnaire
Time frame: At baseline (day 0)
25 secondary outcomes
Proportion of patients vaccinated against influenza and pneumococcal bacteria
Time frame: At baseline (day 0)
Proportion of reasons of non-vaccination, globally and for each type of vaccination.
Time frame: At baseline (day 0)
Proportion of factors influencing rheumatologists to propose vaccination.
Time frame: At baseline (day 0)
Proportion of vaccinated patients who present a good medication adherence to RA specific therapies
Time frame: At baseline (day 0)
Proportion of patients using electronic health tools
Time frame: At baseline (day 0)
Proportion of patients using electronic health tools who present a good medication adherence to RA specific therapies
Time frame: At baseline (day 0)
Proportion of patients with a special diet, globally and by type of diet
Time frame: At baseline (day 0)
Proportion of patients presenting functional bowel disorder
Time frame: At baseline (day 0)
Proportion of patients with a special diet who present a good medication adherence to RA specific therapies
Time frame: At baseline (day 0)
Number of patients with a good medication adherence, according to age
Time frame: At baseline (day 0)
Number of patients with a good medication adherence, according to gender
Time frame: At baseline (day 0)
Number of patients with a good medication adherence, according to socio-professional category
Time frame: At baseline (day 0)
Number of patients with a good medication adherence, according to educational level
Time frame: At baseline (day 0)
Number of patients with a good medication adherence, according to involvement in a patients association
Time frame: At baseline (day 0)
Number of patients with a good medication adherence, according to alcohol and/or tobacco consumption
Time frame: At baseline (day 0)
Number of patients with a good medication adherence, according to disease duration
Time frame: At baseline (day 0)
Number of patients with a good medication adherence, according to rheumatoid factor and/or ACPA positivity
Time frame: At baseline (day 0)
Number of patients with a good medication adherence, according to DAS28 score levels
Time frame: At baseline (day 0)
Number of patients with a good medication adherence, according to actual RA treatments
Time frame: At baseline (day 0)
Number of patients with a good medication adherence, according to the use of alternative therapies (acupuncture and/or sophrology).
Time frame: At baseline (day 0)
Number of patients for each personality trait category
Time frame: At baseline (day 0)
Number of patients with a good medication adherence, according to each personality trait category
Time frame: At baseline (day 0)
Number of patients with a vaccination coverage, according to each personality trait category.
Time frame: At baseline (day 0)
Number of patients with a special diet, according to each personality trait category
Time frame: At baseline (day 0)
Number of patients using electronic health tools, according to each personality trait category
Time frame: At baseline (day 0)
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 22 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Marie-Elise TRUCHETET, MD, PhD principal investigator
University Hospital, Bordeaux
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid, run by University Hospital, Bordeaux at 5 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 4 inclusion and 2 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 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Proportion of patients who presented a good medication adherence according to the medication adherence questionnaire (time frame: At baseline (day 0)). 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 22 Jun 2020.