Multiple SclerosisFELSA-SEPNCT04837352
Therapeutic Adherence of Multiple Sclerosis Patients
An observational study of Multiple Sclerosis, run by Lille Catholic University at 4 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Study of the role of sociocognitive factors
- How many people
- 153 participants
- Where
- 4 sitesFrance
- Study dates
- 18 Jan 2022to 18 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons with multiple sclerosis who will be recruited during a routine neurological consultation and who present eligibility criterion.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
CHRU DE Bordeaux
Bordeaux
Florian HONTARREDE
Aurélie RUET
- Recruiting
Hôpital Saint-Vincent de Paul
Lille, 59000
Axelle DEBROUX
Bruno LENNE, PhD
- Recruiting
Hôpital Saint-Philibert
Lomme, 59462
Caroline MASSOT, MD
Caroline MASSOT, MD
- Recruiting
CHRU de Strasbourg
Strasbourg
Carole BERTHE
Thomas SENGER
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Study of the role of sociocognitive factors
- Keywords
- Theory of Planned Behaviour, Therapeutic adherence, Sociocognitive and interpersonal factors
- Medical subject headings
- Multiple Sclerosis, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study of the role of sociocognitive factorsOther
Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Study of the role of sociocognitive factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (10)
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).
Measured: 3 weeks
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.
Measured: 6 months
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
Measured: 6 months
Illness duration in days
In order to evaluate the vulnerability and protective factors related to somatic disease illness duration will be evaluated.
Measured: 3 weeks
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
Measured: 3 weeks
Relapses number
In order to evaluate the vulnerability and protective factors related to somatic disease number of relapses will be evaluated
Measured: 3 weeks
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.
Measured: 3 weeks
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.
Measured: 3 weeks
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)
Measured: 3 weeks
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)
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start18 Jan 2022
- Primary completion18 Jan 2025 (estimated)
- Study completion18 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno Lenne, Principal investigator, Hôpital Saint Vincent de Paul, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837352
- Sponsor's protocol ID
- RC-P00105
- Acronym
- FELSA-SEP
- Status last verified
- Mar 2024
- First submitted
- 2 Feb 2021
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstacles and Levers of the Therapeutic Adherence of Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT04837352
- Acronym / sponsor ID
- FELSA-SEP / RC-P00105
- Conditions
- Multiple Sclerosis
- Keywords
- Theory of Planned Behaviour, Therapeutic adherence, Sociocognitive and interpersonal factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 18 Jan 2025 (estimated)
- Study completion
- 18 Oct 2025 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple sclerosis patients | – | Other: Study of the role of sociocognitive factorsPatients with multiple sclerosis over 18 years old who have already started a long-term treatment and consent to participate to the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons with multiple sclerosis who will be recruited during a routine neurological consultation and who present eligibility criterion.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study of the role of sociocognitive factorsQuestionnaires | Other | Multiple sclerosis patients |
Primary outcome
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).
10 secondary outcomes
Perceived threat measured with a self-assessment form
Time frame: 3 weeks
Perceived interpersonal relationships quality measure by the perceived social support questionnaire (QSSP)
Time frame: 6 months
Perceived interpersonal relationships quality measure by the 4-Point ordinal Alliance Scale (11-items 4-PAS)
Time frame: 6 months
Illness duration in days
Time frame: 3 weeks
Handicap will be evaluated by the Expanded Disability Status Scale (EDSS)
Time frame: 3 weeks
Relapses number
Time frame: 3 weeks
Fatigue perceived through the FSS (Fatigue Severity Scale)
Time frame: 3 weeks
Cognitive disorders through the SDMT (Symbol Digit Modalities Test)
Time frame: 3 weeks
Anxiety-depressive symptoms measured by the Hospital Anxiety and Depression Scale (HADS)
Time frame: 3 weeks
Personality traits measured by the Big Five Inventory-FR questionnaire (BFI-FR)
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Lenne principal investigator
Hôpital Saint Vincent de Paul, Lille
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Lille Catholic University at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie-Paule Lebitasy, MD, PhD (03.20.22.52.69, Lebitasy.Marie-Paule@ghicl.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic adherence evaluated by a Likert scale (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.