Therapeutic Adherence of Multiple Sclerosis Patients (FELSA-SEP)

March 25, 2024 updated by: Lille Catholic University

Obstacles and Levers of the Therapeutic Adherence of Multiple Sclerosis Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

153

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France
        • Recruiting
        • CHRU de Bordeaux
        • Contact:
          • Florian HONTARREDE
        • Principal Investigator:
          • Aurélie RUET
      • Lille, France, 59000
        • Recruiting
        • Hôpital Saint-Vincent de Paul
        • Contact:
          • Axelle DEBROUX
        • Principal Investigator:
          • Bruno LENNE, PhD
      • Lomme, France, 59462
        • Recruiting
        • Hôpital Saint-Philibert
        • Contact:
          • Caroline Massot, MD
        • Principal Investigator:
          • Caroline MASSOT, MD
      • Strasbourg, France
        • Recruiting
        • CHRU de Strasbourg
        • Contact:
          • Carole BERTHE
        • Contact:
          • Thomas SENGER
        • Principal Investigator:
          • Jérôme DE SEZE, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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.

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapeutic adherence evaluated by a Likert scale
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived threat measured with a self-assessment form
Time Frame: 3 weeks
The perceived threat will be measured with a self-assessment form using a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree). This 11-item self-questionnaire provides 2 sub-scores and an overall score (sum of the 2 sub-scores).
3 weeks
Perceived interpersonal relationships quality measure by the perceived social support questionnaire (QSSP)
Time Frame: 6 months
  • The QSSP is a 6 items questionnaire which assess availability and satisfaction with respect to perceived social support.
  • 4-Point ordinal Alliance Scale (11-items 4-PAS). This self-questionnaire concerns the patient's perception about the therapeutic alliance.
6 months
Perceived interpersonal relationships quality measure by the 4-Point ordinal Alliance Scale (11-items 4-PAS)
Time Frame: 6 months
The 4-Point ordinal Alliance Scale (11-items 4-PAS). This self-questionnaire concerns the patient's feelings about the therapeutic alliance and includes eleven items, placing the patient on 5-point scale on : the patient's feeling about the doctor's ability to help him/her; his/her understanding of the symptoms of the illness; the psychological improvement felt; the adaptation to the doctor-patient relationship; the doctor's availability and competence; the clarity of the information given by the doctor and the understanding he/she shows; the doctor's desire of clinical improvement; the quality of the relationship and the understanding of psychological difficulties
6 months
Illness duration in days
Time Frame: 3 weeks
In order to evaluate the vulnerability and protective factors related to somatic disease illness duration will be evaluated.
3 weeks
Handicap will be evaluated by the Expanded Disability Status Scale (EDSS)
Time Frame: 3 weeks

In order to evaluate the vulnerability and protective factors related to somatic the handicap will be evaluated by the EDSS. The EDSS quantifies disability in eight Functional Systems (FS) by assigning a Functional System Score in each of these functional systems.

The clinical meaning of each possible result goes from 0.0: Normal Neurological Exam to 10.0: Death
3 weeks
Relapses number
Time Frame: 3 weeks
In order to evaluate the vulnerability and protective factors related to somatic disease number of relapses will be evaluated
3 weeks
Fatigue perceived through the FSS (Fatigue Severity Scale)
Time Frame: 3 weeks
In order to evaluate the vulnerability and protective factors related to somatic disease fatigue will be evaluated. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity.
3 weeks
Cognitive disorders through the SDMT (Symbol Digit Modalities Test)
Time Frame: 3 weeks
In order to evaluate the vulnerability and protective factors related to somatic disease cognitive disorders will be evaluated The SDMT is a sign coding test that assesses attentional abilities (sustained attention and speed of processing information). Participants are required to use a coded key to match nine abstract symbols paired with numerical digits. The final score is the correct number of substitutions in 90 seconds, and scores range between 0 and 110.
3 weeks
Anxiety-depressive symptoms measured by the Hospital Anxiety and Depression Scale (HADS)
Time Frame: 3 weeks

The vulnerability and protective factors linked to psychological functioning- as Anxiety-depressive symptoms will be determined.

- Personality traits: Big Five Inventory-FR questionnaire (BFI-FR)
3 weeks
Personality traits measured by the Big Five Inventory-FR questionnaire (BFI-FR)
Time Frame: 3 weeks

The vulnerability and protective factors linked to psychological functioning as personality traits will be determined.

The Big Five personality traits is a suggested grouping for personality traits. The theory identifies five factors:

  • openness to experience (inventive/curious vs. consistent/cautious)
  • conscientiousness (efficient/organized vs. extravagant/careless)
  • extraversion (outgoing/energetic vs. solitary/reserved)
  • agreeableness (friendly/compassionate vs. challenging/callous)
  • neuroticism (sensitive/nervous vs. resilient/confident)
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lille Catholic University

Investigators

  • Principal Investigator: Bruno Lenne, Hôpital Saint Vincent de Paul, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2022

Primary Completion (Estimated)

January 18, 2025

Study Completion (Estimated)

October 18, 2025

Study Registration Dates

First Submitted

February 2, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-P00105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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