Therapeutic Adherence of Multiple Sclerosis Patients (FELSA-SEP)
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| ClinicalTrials.gov Identifier: NCT04837352 |
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Recruitment Status :
Recruiting
First Posted : April 8, 2021
Last Update Posted : January 6, 2022
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| Condition or disease | Intervention/treatment |
|---|---|
| Multiple Sclerosis | Other: Study of the role of sociocognitive factors |
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 |
| Estimated Enrollment : | 153 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official Title: | Obstacles and Levers of the Therapeutic Adherence of Multiple Sclerosis Patients |
| Actual Study Start Date : | November 30, 2021 |
| Estimated Primary Completion Date : | November 30, 2024 |
| Estimated Study Completion Date : | November 30, 2024 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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
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Other: Study of the role of sociocognitive factors
Questionnaires |
- 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).
- 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).
- 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.
- 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
- 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.
- 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
- 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
- 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.
- 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.
- 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)
- 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)
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04837352
| Contact: Amélie Lausiaux, MD, PhD | 03.20.22.52.69 | lansiaux.amelie@ghicl.net | |
| Contact: Valentine Duriez | 03.20.22.59.02 | duriez.valentine@ghicl.net |
| France | |
| Hôpital Saint-Vincent de Paul | Recruiting |
| Lille, France, 59000 | |
| Contact: Bruno Lenne, PhD | |
| Hôpital Saint-Philibert | Recruiting |
| Lomme, France, 59462 | |
| Contact: Caroline Massot, MD | |
| Principal Investigator: | Bruno Lenne | Hôpital Saint-Vincent de Paul - Lille |
| Responsible Party: | Lille Catholic University |
| ClinicalTrials.gov Identifier: | NCT04837352 |
| Other Study ID Numbers: |
RC-P00105 |
| First Posted: | April 8, 2021 Key Record Dates |
| Last Update Posted: | January 6, 2022 |
| Last Verified: | January 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Theory of Planned Behaviour Therapeutic adherence Sociocognitive and interpersonal factors |
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Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |