Influence of Therapeutic Failure on the Psychosocial Experience in Multiple Sclerosis
ConditionMultiple Sclerosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Caen
About this trial
Multiple sclerosis (MS), an inflammatory, neurodegenerative disease of the central nervous system, affects around 120,000 patients in France and is the leading cause of non-traumatic disability in young adults. It affects patients' health-related quality of life (QoL) and has a significant economic impact on patients and society as a whole. Early initiation of disease-modifying therapy (DMT) is recommended in relapsing-remitting MS (RRMS). Nevertheless, according to a recent French cohort, 30% of patients initially treated with a first-line FT will switch to a highly effective compound within 5 years due to its ineffectiveness. Therapeutic failure (Th-F) is therefore a frequent occurrence, but its psychological, social and economic consequences are poorly understood. These elements are generally the subject of measurements reported by patients, and several studies have highlighted the importance of taking them into account in the management of these patients.
Here, the investigators will study two categories of these measures in a Th-F situation. On the one hand, patient-reported outcome measurements (PROMs) will be examined. Patients' psychological distress and their QoL are two important examples of psychosocial impacts in patients with MS, compared to the general population. The impact on activity levels is also well known, but the specific effect of Th-F has not yet been studied. On the other hand, patients' experiences of their care pathway and their opinion on the quality of care (patient-reported experience measurement \[PREM\]) will also be studied. Some PREMs refer to care coordination, satisfaction with the relationship with carers or doctors' empathy levels. To date, data on the experience of MS patients regarding their care pathway remains limited and non-existent during Th-F.
Finally, the influence of socioeconomic status (SES) on PROMs and PREMs is worth considering. In the general population, patients' experience of care can be influenced by their socioeconomic status. Compared with research on other diseases (notably cardiovascular diseases and cancers), there is relatively little work on the association between socioeconomic status and MS and none has focused on the topic of Th-F.
The investigators therefore hypothesise that a quality of care perceived favourably by MS patients may moderate the negative impact of Th-F on their QoL, anxiety/depression and activity levels (as recently described in oncology), and a more recent measure of abilities assessing well-being defined in a broad sense, as a function of their SES.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient aged 18 or over.
Patient with RRMS according to McDonald 2024 criteria.
Uninterrupted use of a moderately effective treatment, or highly effective treatment only if it is the first DMT, for at least 6 months.
Collection of non-objection.
Disqualifiers
Patient with progressive MS.
Patient treated continuously with the same DMT for 3 years or more.
Patient who received a second line DMT or an immunosuppressant before taking a first line DMT.
Patients who have received mitoxantrone as the first treatment
Trial population
RRMS patients aged 18 or over with uninterrupted use of a moderately effective treatment, or highly effective treatment only if it is the first DMT, for at least 6 months.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Questionnaires
Other interventionAt inclusion (T0), TE if event occurs and T1: Completion of 5 questionnaires (MusiQoL, HADS, ICECAP-A, iPCQ, MusiCare).
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Occurrence of Therapeutic Failure1 intervention
Group B: Absence of Therapeutic Failure1 intervention
Trial outcomes
Primary outcomes
1
Quality of life : The International Multiple Sclerosis Quality of Life Questionnaire (MusiQoL)
The International Multiple Sclerosis Quality of Life Questionnaire (MusiQoL) is a multidimensional, self-administered questionnaire that has been developed internationally (including a French version). It comprises 31 questions describing nine dimensions (daily activities, psychological well-being, relationships with friends, symptoms, relationships with family, relationships with the healthcare system, emotional and sexual life, adaptation, and rejection). Each item is scored from 1 to 5. The score of each dimension is obtained by computing the mean of the item scores of the dimension. All dimension scores are linearly transformed to a 0-100 scale. A higher score indicates a higher level of health-related quality of life.
Time frame
2 yearsSecondary outcomes
1
Psychological distress : The Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) is validated in French. It contains 14 items divided into two dimensions (anxiety and depression). Each item is scored from 0 to 3. The score for each subscale is the sum of the 7 items (ranging from 0-21). A higher score indicates a higher distress. This questionnaire has already been used with MS patients and has shown good psychometric indicators.
Time frame
2 years2
Well-being : The ICEpop CAPability measure for Adults (ICECAP-A)
The ICEpop CAPability measure for Adults (ICECAP-A) is a measure of the capability of the general adult population (18+) intended for use in economic evaluation and focused on well-being in the broad sense, rather than health. ICECAP-A comprises five attributes (attachment, stability, fulfilment, pleasure, autonomy). Each item is scored from 1 to 4. The total score is the sum of the 5 attributes (ranging 5-20). A higher score indicates a higher quality of life/capability. Qualitative and quantitative studies on the validity of ICECAP-A have been carried out and a French translation of ICECAP-A has been developed for the general population.
Time frame
2 years3
Activity levels: The self-administered iMTA Productivity Cost Questionnaire (iPCQ)
The self-administered iMTA Productivity Cost Questionnaire (iPCQ) measure the impact of the disease on market and household activities. This recently validated questionnaire, available in French, comprises 18 items, of which 9 are general questions to collect demographic information, such as age, sex and respondents' work status. iPCQ includes three modules measuring productivity losses of paid work due to 1) absenteeism and 2) presenteeism and productivity losses related to 3) unpaid work.
Time frame
2 years4
Quality of care: MusiCare
MusiCare is the only French-language questionnaire specific to MS for assessing the quality of care as perceived by MS patients and their careers. It comprises 35-item encompassing 5 domains: information about the disease (11), information about the treatments/medical investigations (8), relationships with healthcare teams (8), healthcare access (5) and reception conditions in care centers (3). Each item is scored from 1 to 5. All dimension scores are linearly transformed and standardized using a scale ranging from 0 to 100. A higher score indicates a higher self-perceived care management quality.
Time frame
2 yearsLocations
Sponsors and contacts
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University Hospital, Caen
Lead sponsor
University Hospital, Lille
Collaborator
Groupement des Hôpitaux de l'Institut Catholique de Lille
Collaborator
Centre Hospitalier Universitaire, Amiens
Collaborator
University Hospital, Rouen
Collaborator
Source ClinicalTrials.gov
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