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

Axial Spondyloarthritis Clinical Trial

— MAINTAIN II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04925037
• Other study ID #: RNI 2021 TOURNADRE
• Status: Recruiting
• Start date: June 21, 2021
• Est. completion date: June 21, 2022

Study information

• Verified date: March 2022
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 04 73 75 11 95
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 21, 2022
• Est. primary completion date: June 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Spondylarthritis

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeaux
France	CHU Clermont-Ferrand	Clermont-Ferrand
France	CHU Limoges	Limoges
France	CHU Montpellier	Montpellier
France	Chu Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adherence to biotherapies	Proportion of spondyloarthritis patients with good adherence to biotherapies. Adherence was assessed by Girerd's self-administered questionnaire score.; Six questions self-questionnaire, Yes =1 and No = 0; Patients are then classified as follows: Score = 0: Good adherence to therapy; Score = 1 or 2: minimal adherence problem; Score > 3: Poor adherence to therapy	Day 1
Secondary	Proportion of patients who received influenza and pneumococcal vaccinations	The patient checks on the self-questionnaire if he is vaccinated or not against influenza and pneumococcus	Day 1
Secondary	Proportion of vaccinated patients with good adherence to biologic treatment.	Proportion of patients who indicated to be vaccinated and who has a GIRERD score =0	Day 1
Secondary	Proportion of patients using digital health tools with good adherence to biologic treatment.	Proportion of patients who checked yes for users of digital health tools with a GIRERD score =0	Day 1
Secondary	Proportion of patients on a diet and good adherence to biologic treatment.	Proportion of patients who reported being on a diet with a GIRERD score = 0	Day 1
Secondary	Proportion of Inflammatory bowel disease (IBD) patients with good adherence to biologic treatment	Proportion of patients with crohn's disease or ulcerative colitis indicated by the physician with a GIRERD score =0	Day 1
Secondary	Proportion of patients with regular physical activity and good adherence to biologic treatment.	Proportion of patients who are physically active every day (defined by the World Health Organisation as 150 minutes per week of moderate intensity activity, or 75 minutes of high intensity activity ) and have a GIRERD score =0	Day 1
Secondary	Proportion of fibromyalgia patients with good adherence to biologic treatment	Fibromyalgia diagnosis will be evaluated by the answers to the Fibromyalgia Rapid Screening Tool self-questionnaire. 6-question closed-ended questionnaire. (YES=1, NO=0). Score = 5 = Fibromyalgia confirmed.; Proportion of patient who have a score GIRERD = 0 and FiRST score = 5	Day 1
Secondary	Proportions of patients with catastrophic thoughts and good adherence to biologic treatment.	the Patient Catastrophing Scale (PCS) is a broad self report measure of pain catastrophizing and consists of 13 items scored using a 5-point Likert scales from 0 (never) to 4 (always) points. The total score for the PCS equals 52. Responses are summed to create a total score, with higher scores indicating greater pain catastrophizing levels. A score of more than 24 indicates a high level of catastrophizing.	Day 1
Secondary	Proportions of patients with anxiety and depressive disorders in patients with good adherence to biologic treatment	Anxiety and depression disorders were assessed by the Hospital Anxiety and Depression Scale (HADS). The HADS questionnaire is composed of two parts: one part includes 7 items for screening for depression; and a second one also includes 7 items for the screening for anxiety disorders. A score between 0 and 3 is assigned to each item. The score total per party varies between 0 and 21. Score = 11 = Anxiety or depression confirmed.; Proportion of patient who has HADS-anxiety and/or HADS-depression = 11 and a GIRERD score = 0.	Day 1