Clinical trial NCT03754855: Impact of Behavioral Factors on Treatment Adherence in a Sample of Rheumatoid Arthritis Patients
Official title: Impact of Behavioral Factors on Treatment Adherence in a Sample of Rheumatoid Arthritis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Keywords: Rheumatoid arthritis
medication adherence
vaccination coverage
electronic health tools
diet
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Association Aquitaine de Recherche Clinique en Rhumatologie
First posted: 2018-11-27
Enrollment: 590
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patient aged over 18 years old, affected by RA according to ACR/EULAR 2010 criteria

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients who presented a good medication adherence according to the medication adherence questionnaire
timeFrame: At baseline (day 0)
Secondary outcomes:
measure: Proportion of patients vaccinated against influenza and pneumococcal bacteria
timeFrame: At baseline (day 0)
measure: Proportion of reasons of non-vaccination, globally and for each type of vaccination.
timeFrame: At baseline (day 0)
measure: Proportion of factors influencing rheumatologists to propose vaccination.
timeFrame: At baseline (day 0)
measure: Proportion of vaccinated patients who present a good medication adherence to RA specific therapies
timeFrame: At baseline (day 0)
measure: Proportion of patients using electronic health tools
timeFrame: At baseline (day 0)
measure: Proportion of patients using electronic health tools who present a good medication adherence to RA specific therapies
timeFrame: At baseline (day 0)
measure: Proportion of patients with a special diet, globally and by type of diet
timeFrame: At baseline (day 0)
measure: Proportion of patients presenting functional bowel disorder
timeFrame: At baseline (day 0)
measure: Proportion of patients with a special diet who present a good medication adherence to RA specific therapies
timeFrame: At baseline (day 0)
measure: Number of patients with a good medication adherence, according to age
timeFrame: At baseline (day 0)
measure: Number of patients with a good medication adherence, according to gender
timeFrame: At baseline (day 0)
measure: Number of patients with a good medication adherence, according to socio-professional category
timeFrame: At baseline (day 0)
measure: Number of patients with a good medication adherence, according to educational level
timeFrame: At baseline (day 0)
measure: Number of patients with a good medication adherence, according to involvement in a patients association
timeFrame: At baseline (day 0)
measure: Number of patients with a good medication adherence, according to alcohol and/or tobacco consumption
timeFrame: At baseline (day 0)
measure: Number of patients with a good medication adherence, according to disease duration
timeFrame: At baseline (day 0)
measure: Number of patients with a good medication adherence, according to rheumatoid factor and/or ACPA positivity
timeFrame: At baseline (day 0)
measure: Number of patients with a good medication adherence, according to DAS28 score levels
timeFrame: At baseline (day 0)
measure: Number of patients with a good medication adherence, according to actual RA treatments
timeFrame: At baseline (day 0)
measure: Number of patients with a good medication adherence, according to the use of alternative therapies (acupuncture and/or sophrology).
timeFrame: At baseline (day 0)
measure: Number of patients for each personality trait category
timeFrame: At baseline (day 0)
measure: Number of patients with a good medication adherence, according to each personality trait category
timeFrame: At baseline (day 0)
measure: Number of patients with a vaccination coverage, according to each personality trait category.
timeFrame: At baseline (day 0)
measure: Number of patients with a special diet, according to each personality trait category
timeFrame: At baseline (day 0)
measure: Number of patients using electronic health tools, according to each personality trait category
timeFrame: At baseline (day 0)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux - service de rhumatologie
city: Clermont-Ferrand
country: France
facility: Service de Rhumatologie
city: Limoges
country: France
facility: Service de rhumatologie
city: Montpellier
country: France
facility: Service de rhumatologie
city: Toulouse
country: France
facility: Service de Rhumatologie
Study officials:
affiliation: University Hospital, Bordeaux
name: Marie-Elise TRUCHETET, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: