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

Arthritis, Rheumatoid Clinical Trial

— MAINTAIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03754855
• Other study ID #: CHUBX 2018/07
• Status: Completed
• Start date: November 28, 2018
• Est. completion date: July 10, 2019

Study information

• Verified date: June 2020
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 590
• Est. completion date: July 10, 2019
• Est. primary completion date: July 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Behavioral:
• Questionnaire
Questionnaire

Locations

Country	Name	City	State
France	CHU de Bordeaux - service de rhumatologie	Bordeaux
France	Service de Rhumatologie	Clermont-Ferrand
France	Service de rhumatologie	Limoges
France	Service de rhumatologie	Montpellier
France	Service de Rhumatologie	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Association Aquitaine de Recherche Clinique en Rhumatologie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who presented a good medication adherence according to the medication adherence questionnaire		At baseline (day 0)
Secondary	Proportion of patients vaccinated against influenza and pneumococcal bacteria		At baseline (day 0)
Secondary	Proportion of reasons of non-vaccination, globally and for each type of vaccination.		At baseline (day 0)
Secondary	Proportion of factors influencing rheumatologists to propose vaccination.		At baseline (day 0)
Secondary	Proportion of vaccinated patients who present a good medication adherence to RA specific therapies		At baseline (day 0)
Secondary	Proportion of patients using electronic health tools		At baseline (day 0)
Secondary	Proportion of patients using electronic health tools who present a good medication adherence to RA specific therapies		At baseline (day 0)
Secondary	Proportion of patients with a special diet, globally and by type of diet		At baseline (day 0)
Secondary	Proportion of patients presenting functional bowel disorder		At baseline (day 0)
Secondary	Proportion of patients with a special diet who present a good medication adherence to RA specific therapies		At baseline (day 0)
Secondary	Number of patients with a good medication adherence, according to age	Medication adherence will be evaluated with medication adherence questionnaires	At baseline (day 0)
Secondary	Number of patients with a good medication adherence, according to gender	Medication adherence will be evaluated with medication adherence questionnaires	At baseline (day 0)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)