Therapeutic Adherence of Multiple Sclerosis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-18

Study Completion Date

2025-10-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Study of the role of sociocognitive factors

Intervention Type OTHER

Questionnaires

Interventions

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Study of the role of sociocognitive factors

Questionnaires

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No