Therapeutic Adherence of Multiple Sclerosis Patients

Multiple Sclerosis Clinical Trial

— FELSA-SEP  

Official title:

Obstacles and Levers of the Therapeutic Adherence of Multiple Sclerosis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04837352
• Other study ID #: RC-P00105
• Status: Recruiting
• Start date: January 18, 2022
• Est. completion date: October 18, 2025

Study information

• Verified date: March 2024
• Source: Lille Catholic University
• Contact: Marie-Paule Lebitasy, MD, PhD
• Phone: 03.20.22.52.69
• Email: Lebitasy.Marie-Paule[@]ghicl.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 153
• Est. completion date: October 18, 2025
• Est. primary completion date: January 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Study of the role of sociocognitive factors
Questionnaires

Locations

Country	Name	City	State
France	CHRU DE Bordeaux	Bordeaux
France	Hôpital Saint-Vincent de Paul	Lille
France	Hôpital Saint-Philibert	Lomme
France	CHRU de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Perceived threat measured with a self-assessment form	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
Secondary	Perceived interpersonal relationships quality measure by the perceived social support questionnaire (QSSP)	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
Secondary	Perceived interpersonal relationships quality measure by the 4-Point ordinal Alliance Scale (11-items 4-PAS)	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
Secondary	Illness duration in days	In order to evaluate the vulnerability and protective factors related to somatic disease illness duration will be evaluated.	3 weeks
Secondary	Handicap will be evaluated by the Expanded Disability Status Scale (EDSS)	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
Secondary	Relapses number	In order to evaluate the vulnerability and protective factors related to somatic disease number of relapses will be evaluated	3 weeks
Secondary	Fatigue perceived through the FSS (Fatigue Severity Scale)	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
Secondary	Cognitive disorders through the SDMT (Symbol Digit Modalities Test)	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
Secondary	Anxiety-depressive symptoms measured by the Hospital Anxiety and Depression Scale (HADS)	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
Secondary	Personality traits measured by the Big Five Inventory-FR questionnaire (BFI-FR)	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