Clinical trial NCT04837352: Therapeutic Adherence of Multiple Sclerosis Patients
Official title: Obstacles and Levers of the Therapeutic Adherence of Multiple Sclerosis Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Keywords: Theory of Planned Behaviour
Therapeutic adherence
Sociocognitive and interpersonal factors
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Therapeutic adherence evaluated by a Likert scale
timeFrame: 6 months
Secondary outcomes:
measure: Perceived threat measured with a self-assessment form
timeFrame: 3 weeks
measure: Perceived interpersonal relationships quality measure by the perceived social support questionnaire (QSSP)
timeFrame: 6 months
measure: Perceived interpersonal relationships quality measure by the 4-Point ordinal Alliance Scale (11-items 4-PAS)
timeFrame: 6 months
measure: Illness duration in days
timeFrame: 3 weeks
measure: Handicap will be evaluated by the Expanded Disability Status Scale (EDSS)
timeFrame: 3 weeks
measure: Relapses number
timeFrame: 3 weeks
measure: Fatigue perceived through the FSS (Fatigue Severity Scale)
timeFrame: 3 weeks
measure: Cognitive disorders through the SDMT (Symbol Digit Modalities Test)
timeFrame: 3 weeks
measure: Anxiety-depressive symptoms measured by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3 weeks
measure: Personality traits measured by the Big Five Inventory-FR questionnaire (BFI-FR)
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHRU DE Bordeaux
city: Lille
country: France
facility: Hôpital Saint-Vincent de Paul
city: Lomme
country: France
facility: Hôpital Saint-Philibert
city: Strasbourg
country: France
facility: CHRU de Strasbourg
Study officials:
affiliation: Hôpital Saint Vincent de Paul, Lille
name: Bruno Lenne
role: PRINCIPAL_INVESTIGATOR
References: