Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03754855
Acronym
MAINTAIN
Enrollment
590
Registered
2018-11-27
Start date
2018-11-28
Completion date
2019-07-10
Last updated
2020-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid

Keywords

Rheumatoid arthritis, medication adherence, vaccination coverage, electronic health tools, diet

Brief 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. 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.

Interventions

BEHAVIORALQuestionnaire

Questionnaire

Sponsors

Association Aquitaine de Recherche Clinique en Rhumatologie
CollaboratorOTHER
University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Proportion of patients who presented a good medication adherence according to the medication adherence questionnaireAt baseline (day 0)

Secondary

MeasureTime frameDescription
Proportion of reasons of non-vaccination, globally and for each type of vaccination.At baseline (day 0)
Proportion of factors influencing rheumatologists to propose vaccination.At baseline (day 0)
Proportion of vaccinated patients who present a good medication adherence to RA specific therapiesAt baseline (day 0)
Proportion of patients using electronic health toolsAt baseline (day 0)
Proportion of patients using electronic health tools who present a good medication adherence to RA specific therapiesAt baseline (day 0)
Proportion of patients with a special diet, globally and by type of dietAt baseline (day 0)
Proportion of patients presenting functional bowel disorderAt baseline (day 0)
Proportion of patients with a special diet who present a good medication adherence to RA specific therapiesAt baseline (day 0)
Number of patients with a good medication adherence, according to ageAt baseline (day 0)Medication adherence will be evaluated with medication adherence questionnaires
Number of patients with a good medication adherence, according to genderAt baseline (day 0)Medication adherence will be evaluated with medication adherence questionnaires
Number of patients with a good medication adherence, according to socio-professional categoryAt baseline (day 0)Medication adherence will be evaluated with medication adherence questionnaires
Number of patients with a good medication adherence, according to educational levelAt baseline (day 0)Medication adherence will be evaluated with medication adherence questionnaires
Proportion of patients vaccinated against influenza and pneumococcal bacteriaAt baseline (day 0)
Number of patients with a good medication adherence, according to alcohol and/or tobacco consumptionAt baseline (day 0)Medication adherence will be evaluated with medication adherence questionnaires
Number of patients with a good medication adherence, according to disease durationAt baseline (day 0)Medication adherence will be evaluated with medication adherence questionnaires
Number of patients with a good medication adherence, according to rheumatoid factor and/or ACPA positivityAt baseline (day 0)Medication adherence will be evaluated with medication adherence questionnaires
Number of patients with a good medication adherence, according to DAS28 score levelsAt baseline (day 0)Medication adherence will be evaluated with medication adherence questionnaires
Number of patients with a good medication adherence, according to actual RA treatmentsAt baseline (day 0)Medication adherence will be evaluated with medication adherence questionnaires
Number of patients with a good medication adherence, according to the use of alternative therapies (acupuncture and/or sophrology).At baseline (day 0)Medication adherence will be evaluated with medication adherence questionnaires
Number of patients for each personality trait categoryAt baseline (day 0)Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire.
Number of patients with a good medication adherence, according to each personality trait categoryAt 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.
Number of patients with a vaccination coverage, according to each personality trait category.At baseline (day 0)Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire.
Number of patients with a special diet, according to each personality trait categoryAt baseline (day 0)Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire
Number of patients using electronic health tools, according to each personality trait categoryAt baseline (day 0)Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire
Number of patients with a good medication adherence, according to involvement in a patients associationAt baseline (day 0)Medication adherence will be evaluated with medication adherence questionnaires

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026