Impact of Behavioral Factors on Treatment Adherence in a Sample of Rheumatoid Arthritis Patients (MAINTAIN)

June 19, 2020 updated by: University Hospital, Bordeaux
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
590

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • CHU de Bordeaux - service de rhumatologie
      • Clermont-Ferrand, France
        • Service de Rhumatologie
      • Limoges, France
        • Service de Rhumatologie
      • Montpellier, France
        • Service de Rhumatologie
      • Toulouse, France
        • Service de Rhumatologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient aged over 18 years old, affected by RA according to ACR/EULAR 2010 criteria

Description

Inclusion Criteria:

  • patient aged over 18 years old,
  • affected by RA according to ACR/EULAR 2010 criteria,
  • francophone,
  • and informed about the aims of the study.

Exclusion Criteria:

  • guardianship patient,
  • patient who refuses to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Rheumatoid Arthritis patients
patients affected by RA according to ACR/EULAR 2010 criteria
Behavioral: Questionnaire
Questionnaire

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of patients who presented a good medication adherence according to the medication adherence questionnaire
Time Frame: At baseline (day 0)
At baseline (day 0)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of patients vaccinated against influenza and pneumococcal bacteria
Time Frame: At baseline (day 0)
At baseline (day 0)
Proportion of reasons of non-vaccination, globally and for each type of vaccination.
Time Frame: At baseline (day 0)
At baseline (day 0)
Proportion of factors influencing rheumatologists to propose vaccination.
Time Frame: At baseline (day 0)
At baseline (day 0)
Proportion of vaccinated patients who present a good medication adherence to RA specific therapies
Time Frame: At baseline (day 0)
At baseline (day 0)
Proportion of patients using electronic health tools
Time Frame: At baseline (day 0)
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)
At baseline (day 0)
Proportion of patients with a special diet, globally and by type of diet
Time Frame: At baseline (day 0)
At baseline (day 0)
Proportion of patients presenting functional bowel disorder
Time Frame: At baseline (day 0)
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)
At baseline (day 0)
Number of patients with a good medication adherence, according to age
Time Frame: At baseline (day 0)
Medication adherence will be evaluated with medication adherence questionnaires
At baseline (day 0)
Number of patients with a good medication adherence, according to gender
Time Frame: At baseline (day 0)
Medication adherence will be evaluated with medication adherence questionnaires
At baseline (day 0)
Number of patients with a good medication adherence, according to socio-professional category
Time Frame: At baseline (day 0)
Medication adherence will be evaluated with medication adherence questionnaires
At baseline (day 0)
Number of patients with a good medication adherence, according to educational level
Time Frame: At baseline (day 0)
Medication adherence will be evaluated with medication adherence questionnaires
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)
Medication adherence will be evaluated with medication adherence questionnaires
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)
Medication adherence will be evaluated with medication adherence questionnaires
At baseline (day 0)
Number of patients with a good medication adherence, according to disease duration
Time Frame: At baseline (day 0)
Medication adherence will be evaluated with medication adherence questionnaires
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)
Medication adherence will be evaluated with medication adherence questionnaires
At baseline (day 0)
Number of patients with a good medication adherence, according to DAS28 score levels
Time Frame: At baseline (day 0)
Medication adherence will be evaluated with medication adherence questionnaires
At baseline (day 0)
Number of patients with a good medication adherence, according to actual RA treatments
Time Frame: At baseline (day 0)
Medication adherence will be evaluated with medication adherence questionnaires
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)
Medication adherence will be evaluated with medication adherence questionnaires
At baseline (day 0)
Number of patients for each personality trait category
Time Frame: At baseline (day 0)
Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire.
At baseline (day 0)
Number of patients with a good medication adherence, according to each personality trait category
Time Frame: At baseline (day 0)
Medication adherence will be evaluated with medication adherence questionnaires. Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire.
At baseline (day 0)
Number of patients with a vaccination coverage, according to each personality trait category.
Time Frame: At baseline (day 0)
Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire.
At baseline (day 0)
Number of patients with a special diet, according to each personality trait category
Time Frame: At baseline (day 0)
Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire
At baseline (day 0)
Number of patients using electronic health tools, according to each personality trait category
Time Frame: At baseline (day 0)
Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire
At baseline (day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Association Aquitaine de Recherche Clinique en Rhumatologie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marie-Elise TRUCHETET, MD, PhD, CHU Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 28, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 10, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUBX 2018/07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arthritis, Rheumatoid

Clinical Trials on Questionnaire

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings