Therapeutic Adherence of Multiple Sclerosis Patients

NCT04837352 | Recruiting

• 1 other identifier: RC-P00105
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Multiple Sclerosis

Keywords

Theory of Planned Behaviour; Therapeutic adherence; Sociocognitive and interpersonal factors

Outcome Measures

Primary Outcomes (1)

• Therapeutic adherence evaluated by a Likert scale

  This 19-item self-questionnaire provides 5 sub-scores corresponding to each of the sub-dimensions (Attitudes, Subjective norms, Perception of control, Behavioural intention and Behaviour) and an overall score (sum of the 5 sub-scores).

  6 months

Secondary Outcomes (10)

• Perceived threat measured with a self-assessment form

  3 weeks

• Perceived interpersonal relationships quality measure by the perceived social support questionnaire (QSSP)

  6 months

• Perceived interpersonal relationships quality measure by the 4-Point ordinal Alliance Scale (11-items 4-PAS)

  6 months

• Illness duration in days

  3 weeks

• Handicap will be evaluated by the Expanded Disability Status Scale (EDSS)

  3 weeks

Study Arms (1)

Multiple sclerosis patients

Patients with multiple sclerosis over 18 years old who have already started a long-term treatment and consent to participate to the study

Other: Study of the role of sociocognitive factors

Interventions

Study of the role of sociocognitive factors OTHER

Questionnaires

Multiple sclerosis patients

Eligibility Criteria

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

Study Population

Persons with multiple sclerosis who will be recruited during a routine neurological consultation and who present eligibility criterion.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lille Catholic University: lead

Study Sites (4)

CHRU DE Bordeaux

Bordeaux, France

RECRUITING

Hôpital Saint-Vincent de Paul

Lille, 59000, France

RECRUITING

Hôpital Saint-Philibert

Lomme, 59462, France

RECRUITING

CHRU de Strasbourg

Strasbourg, France

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Health Behavior; Behavior

Study Officials

• Bruno Lenne

  Hôpital Saint Vincent de Paul, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Paule Lebitasy, MD, PhD

CONTACT

03.20.22.52.69; Lebitasy.Marie-Paule@ghicl.net

Lucile POISSON, PhD

CONTACT

03.20.22.59.02; poisson.lucile@ghicl.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: April 8, 2021
• Study Start: January 18, 2022
• Primary Completion: January 18, 2025
• Study Completion: October 18, 2025
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)