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

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: Completed
• Conditions: Arthritis, Rheumatoid
• Intervention / Treatment: Behavioral: Questionnaire

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: Observational
• Enrollment (Actual): 590

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rheumatoid Arthritis patients; patients affected by RA according to ACR/EULAR 2010 criteria	Behavioral: Questionnaire; Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients who presented a good medication adherence according to the medication adherence questionnaire	At baseline (day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients vaccinated against influenza and pneumococcal bacteria		At baseline (day 0)
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 therapies		At baseline (day 0)
Proportion of patients using electronic health tools		At baseline (day 0)
Proportion of patients using electronic health tools who present a good medication adherence to RA specific therapies		At baseline (day 0)
Proportion of patients with a special diet, globally and by type of diet		At baseline (day 0)
Proportion of patients presenting functional bowel disorder		At baseline (day 0)
Proportion of patients with a special diet who present a good medication adherence to RA specific therapies		At baseline (day 0)
Number of patients with a good medication adherence, according to age	Medication adherence will be evaluated with medication adherence questionnaires	At baseline (day 0)
Number of patients with a good medication adherence, according to gender	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	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	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	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	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	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	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	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	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).	Medication adherence will be evaluated with medication adherence questionnaires	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.	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.	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.	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	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	At baseline (day 0)

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Association Aquitaine de Recherche Clinique en Rhumatologie
• Investigators: Principal Investigator: Marie-Elise TRUCHETET, MD, PhD, CHU Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2018
• Primary Completion (Actual): July 10, 2019
• Study Completion (Actual): July 10, 2019

Study Registration Dates

• First Submitted: November 19, 2018
• First Submitted That Met QC Criteria: November 22, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): June 22, 2020
• Last Update Submitted That Met QC Criteria: June 19, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: diet; Rheumatoid arthritis; medication adherence; vaccination coverage; electronic health tools
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID 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