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

NCT03754855 | Completed

• 1 other identifier: CHUBX 2018/07
• Study Type: observational
• Target: 590
• Locations: 1 country
• Sites: 5

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.

Conditions

Arthritis, Rheumatoid

Keywords

Rheumatoid arthritis; medication adherence; vaccination coverage; electronic health tools; diet

Outcome Measures

Primary Outcomes (1)

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

  At baseline (day 0)

Secondary Outcomes (25)

• 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)

Study Arms (1)

Rheumatoid Arthritis patients

patients affected by RA according to ACR/EULAR 2010 criteria

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

Questionnaire

Rheumatoid Arthritis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient aged over 18 years old, affected by RA according to ACR/EULAR 2010 criteria

You may qualify if:

• patient aged over 18 years old,
• affected by RA according to ACR/EULAR 2010 criteria,
• francophone,
• and informed about the aims of the study.

You may not qualify if:

• guardianship patient,
• patient who refuses to participate.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Association Aquitaine de Recherche Clinique en Rhumatologie: collaborator

Study Sites (5)

CHU de Bordeaux - service de rhumatologie

Bordeaux, France

Location

Service de Rhumatologie

Clermont-Ferrand, France

Location

Service de rhumatologie

Limoges, France

Location

Service de rhumatologie

Montpellier, France

Location

Service de Rhumatologie

Toulouse, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Medication Adherence

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Marie-Elise TRUCHETET, MD, PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 27, 2018
• Study Start: November 28, 2018
• Primary Completion: July 10, 2019
• Study Completion: July 10, 2019
• Last Updated: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)