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OpenTrials
Completed

NCT Number: NCT03754855

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Bordeaux - service de rhumatologie, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire

Behavioral

Questionnaire

Primary outcomes

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

    Time frame: At baseline (day 0)

Secondary outcomes

  1. Proportion of patients vaccinated against influenza and pneumococcal bacteria

    Time frame: At baseline (day 0)

  2. Proportion of reasons of non-vaccination, globally and for each type of vaccination.

    Time frame: At baseline (day 0)

  3. Proportion of factors influencing rheumatologists to propose vaccination.

    Time frame: At baseline (day 0)

  4. Proportion of vaccinated patients who present a good medication adherence to RA specific therapies

    Time frame: At baseline (day 0)

  5. Proportion of patients using electronic health tools

    Time frame: At baseline (day 0)

  6. Proportion of patients using electronic health tools who present a good medication adherence to RA specific therapies

    Time frame: At baseline (day 0)

  7. Proportion of patients with a special diet, globally and by type of diet

    Time frame: At baseline (day 0)

  8. Proportion of patients presenting functional bowel disorder

    Time frame: At baseline (day 0)

  9. Proportion of patients with a special diet who present a good medication adherence to RA specific therapies

    Time frame: At baseline (day 0)

  10. Number of patients with a good medication adherence, according to age

    Time frame: At baseline (day 0)

    Medication adherence will be evaluated with medication adherence questionnaires

  11. Number of patients with a good medication adherence, according to gender

    Time frame: At baseline (day 0)

    Medication adherence will be evaluated with medication adherence questionnaires

  12. Number of patients with a good medication adherence, according to socio-professional category

    Time frame: At baseline (day 0)

    Medication adherence will be evaluated with medication adherence questionnaires

  13. Number of patients with a good medication adherence, according to educational level

    Time frame: At baseline (day 0)

    Medication adherence will be evaluated with medication adherence questionnaires

  14. Number of patients with a good medication adherence, according to involvement in a patients association

    Time frame: At baseline (day 0)

    Medication adherence will be evaluated with medication adherence questionnaires

  15. Number of patients with a good medication adherence, according to alcohol and/or tobacco consumption

    Time frame: At baseline (day 0)

    Medication adherence will be evaluated with medication adherence questionnaires

  16. Number of patients with a good medication adherence, according to disease duration

    Time frame: At baseline (day 0)

    Medication adherence will be evaluated with medication adherence questionnaires

  17. Number of patients with a good medication adherence, according to rheumatoid factor and/or ACPA positivity

    Time frame: At baseline (day 0)

    Medication adherence will be evaluated with medication adherence questionnaires

  18. Number of patients with a good medication adherence, according to DAS28 score levels

    Time frame: At baseline (day 0)

    Medication adherence will be evaluated with medication adherence questionnaires

  19. Number of patients with a good medication adherence, according to actual RA treatments

    Time frame: At baseline (day 0)

    Medication adherence will be evaluated with medication adherence questionnaires

  20. Number of patients with a good medication adherence, according to the use of alternative therapies (acupuncture and/or sophrology).

    Time frame: At baseline (day 0)

    Medication adherence will be evaluated with medication adherence questionnaires

  21. Number of patients for each personality trait category

    Time frame: At baseline (day 0)

    Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire.

  22. Number of patients with a good medication adherence, according to each personality trait category

    Time frame: At 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.

  23. Number of patients with a vaccination coverage, according to each personality trait category.

    Time frame: At baseline (day 0)

    Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire.

  24. Number of patients with a special diet, according to each personality trait category

    Time frame: At baseline (day 0)

    Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire

  25. Number of patients using electronic health tools, according to each personality trait category

    Time frame: At baseline (day 0)

    Personality trait categories will be evaluated by the French version of Big Five Inventory questionnaire

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Association Aquitaine de Recherche Clinique en Rhumatologie

Registry information

Acronym: MAINTAIN

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 27, 2018
Registry last updated
Jun 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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