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Clinical Trials/NCT03754855
NCT03754855
Completed
Not Applicable

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

University Hospital, Bordeaux3 sites in 1 country590 target enrollmentNovember 28, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arthritis, Rheumatoid
Sponsor
University Hospital, Bordeaux
Enrollment
590
Locations
3
Primary Endpoint
Proportion of patients who presented a good medication adherence according to the medication adherence questionnaire
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 28, 2018
End Date
July 10, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Bordeaux
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Proportion of patients who presented a good medication adherence according to the medication adherence questionnaire

Time Frame: At baseline (day 0)

Secondary Outcomes

  • Proportion of patients presenting functional bowel disorder(At baseline (day 0))
  • Proportion of reasons of non-vaccination, globally and for each type of 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 factors influencing rheumatologists to propose vaccination.(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 using electronic health tools(At baseline (day 0))
  • Proportion of patients with a special diet, globally and by type of diet(At baseline (day 0))
  • Proportion of patients vaccinated against influenza and pneumococcal bacteria(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 alcohol and/or tobacco consumption(At baseline (day 0))
  • Number of patients with a good medication adherence, according to DAS28 score levels(At baseline (day 0))
  • Number of patients for each personality trait category(At baseline (day 0))
  • Number of patients using electronic health tools, according to each personality trait category(At baseline (day 0))
  • Number of patients with a good medication adherence, according to age(At baseline (day 0))
  • Number of patients with a good medication adherence, according to gender(At baseline (day 0))
  • Number of patients with a good medication adherence, according to involvement in a patients association(At baseline (day 0))
  • Number of patients with a special diet, according to each personality trait category(At baseline (day 0))
  • Number of patients with a good medication adherence, according to educational level(At baseline (day 0))
  • Number of patients with a good medication adherence, according to the use of alternative therapies (acupuncture and/or sophrology).(At baseline (day 0))
  • Number of patients with a vaccination coverage, according to each personality trait category.(At baseline (day 0))
  • Number of patients with a good medication adherence, according to each personality trait category(At baseline (day 0))
  • Number of patients with a good medication adherence, according to socio-professional category(At baseline (day 0))
  • Number of patients with a good medication adherence, according to disease duration(At baseline (day 0))
  • Number of patients with a good medication adherence, according to rheumatoid factor and/or ACPA positivity(At baseline (day 0))
  • Number of patients with a good medication adherence, according to actual RA treatments(At baseline (day 0))

Study Sites (3)

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