Explore the Associations of Behavioral Factors With Treatment Adherence in Axial Spondyloarthritis Patients Treated With Biotherapy.

NCT ID: NCT04925037

Last Updated: 2022-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-21

Study Completion Date

2022-06-21

Brief Summary

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The management of chronic inflammatory rheumatism, including spondyloarthritis (SpA), has been revolutionized in recent decades with the arrival of biological therapy. The success of the current therapeutic strategy is also based on therapeutic compliance. If therapeutic adherence in rheumatoid arthritis patient (RA) is only 66%, it seems even worse in SpA. Few studies report quantitatively the adherence of SpA patients, as well as the predictive or associated factors. The objective of this study is to assess the patient adherence to biologics in patients with axial SpA (SpAax), and to investigate factors influencing this adherence, in particular the association with vaccination coverage, dietary behavior, and digital health tools.

Detailed Description

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Multicentric cross-sectional survey of patients seen in the context of a rheumatology consultation or hospitalization.

On the occasion of a single visit in consultation or hospitalization, an anonymous self-questionnaire will be distributed to patients undergoing SpAax follow-up to assess their compliance with biologic drugs, their vaccination coverage, their diet, the presence of a fibromyalgia syndrome or inflammatory bowel disease, intestinal disorders, regular physical activity and sedentary lifestyle, the frequency and mode of use of mobile applications and/or connected objects related to health, the presence of catastrophic thoughts and the presence of anxiety and depressive disorders. Medical data relevant to routine care will be collected.(Age, sex, weight, height, tobacco and alcohol use, disease characteristics, SpA treatment, comorbidities)

Conditions

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Axial Spondyloarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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self-questionnaire to patients undergoing SpAax follow-up

On the occasion of a single visit in consultation or hospitalization, an anonymous self-questionnaire will be distributed to patients undergoing SpAax follow-up

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patient \>18 years old with axial spondyloarthritis according to ASAS criteria and treated with biotherapy.
* French-speaking, without any understanding problems.

Exclusion Criteria

* Patients under curatorship, guardianship or other legal protection
* Patients refusing to consent to participate in research
* Pregnant and breastfeeding women.
Minimum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Bordeaux

Bordeaux, , France

Site Status RECRUITING

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status NOT_YET_RECRUITING

CHU Limoges

Limoges, , France

Site Status RECRUITING

CHU Montpellier

Montpellier, , France

Site Status RECRUITING

Chu Toulouse

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Lise Laclautre

Role: CONTACT

04 73 75 11 95

Facility Contacts

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Lise laclautre

Role: primary

04 73 75 11 95

Other Identifiers

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RNI 2021 TOURNADRE

Identifier Type: -

Identifier Source: org_study_id

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