Therapeutic Adherence of Multiple Sclerosis Patients

Last updated: March 25, 2024
Sponsor: Lille Catholic University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Sclerosis

Memory Loss

Scar Tissue

Treatment

Study of the role of sociocognitive factors

Clinical Study ID

NCT04837352
RC-P00105
  • Ages > 18
  • All Genders

Study Summary

The goal of this study is to assess the role of sociocognitive and interpersonal factors in the therapeutic adherence of multiple sclerosis patients. This study will provide a better understanding of the socio-psychological issues associated with different types of non-adherence to treatment, and identify the risk factors and vulnerability of each patient.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Multiple sclerosis defined according to McDonald criteria;
  • Already undergone or beginning substantive treatment (self-managed, excludingtreatment administered in hospital)
  • Aged ≥ 18 years;
  • Given the informed consent form.

Exclusion

Exclusion Criteria:

  • Severe cognitive impairment (score below the 5th percentile);
  • Any associated neurological pathology or serious or chronic somatic disease (cancer);
  • Being under a legal protection measure.

Study Design

Total Participants: 153
Treatment Group(s): 1
Primary Treatment: Study of the role of sociocognitive factors
Phase:
Study Start date:
January 18, 2022
Estimated Completion Date:
October 18, 2025

Study Description

Multiple sclerosis is a chronic and progressive disease that affects young adults (between 20 and 40 years old), impacting significantly the patients quality of life.

The adherence to therapy affects the long-term functional clinical course (lower risk of relapses, reduction in disability progression and quality of life). The non-adherence rate to therapy in multiple sclerosis is estimated at 40%. The main identified causes of non-adherence are: forgetting to take treatment and adverse effects of drugs.

Sociocognitive models as the Theory of Planned Behaviour (TPB) have been developed to help to understand and predict health-related behaviours. This model postulates that the intention to adopt a behaviour is one of the major determinants in the context of health. This intention comes from three independent elements :

  • Personal positive or negative attitudes towards the behaviour,

  • Social expectations or entourage perception (subjective norms),

  • Difficulty in accomplishing this behaviour (perceived control)

Multiple sclerosis adherence to therapy studies have mainly focused on somatic variables (physical disability, illness duration, type of treatment) and some clinical variables (cognitive impairment, fatigue, depression). The few studies that have examined the multiple sclerosis therapeutic adherence determinants have mainly taken a one-dimensional perspective, such as perceived control.

In the FELSA-SEP study, the role of sociocognitive factors (norms and beliefs, perceived threat to disease and health behaviours) and interpersonal factors (social support, patient-doctor relationship) will be explored.

Connect with a study center

  • CHRU DE Bordeaux

    Bordeaux,
    France

    Active - Recruiting

  • Hôpital Saint-Vincent de Paul

    Lille, 59000
    France

    Active - Recruiting

  • Hôpital Saint-Philibert

    Lomme, 59462
    France

    Active - Recruiting

  • CHRU de Strasbourg

    Strasbourg,
    France

    Active - Recruiting

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