Multiple Sclerosis, Relapsing-remitting
Conditions
Keywords
multiple sclerosis, peer support, therapeutic adherence
Brief summary
A mixed methods randomized controlled trial pilot study to assess peer support impact on relapsing-remitting multiple sclerosis patients' therapeutic adherence.
Detailed description
Multiple sclerosis (MS) is a debilitating and incurable chronic disease. Patients might benefit from peer support provided by patients entitled to give advice on daily life management with MS. Studies have shown that peer support can enhance chronic patients' quality of life in Psychiatry and Oncology. This pilot study aims at assessing the impact of peer support on therapeutic adherence and quality of life in patients with MS, but also to appraise the project feasibility and acceptability among the healthcare team, with large-scale implementation in mind. This mixed methods pilot study consists in a monocentric open-label randomized controlled trial. It is located in Nantes, France, and aims to recruit 60 patients with relapsing-remitting MS undergoing drug therapy from the Nantes University Hospital Neurology Department. Patients will be randomized 1:1 to receive either usual care only or usual care combined with peer support (3 individual sessions at 1, 3 and 5 months with a peer support specialist). Primary outcome is enhanced therapeutic adherence 6 months after baseline, secondary outcomes include therapeutic compliance, quality of life, anxiety and depression, social support. All dimensions will be assessed using validated health questionnaires at baseline and at 6 months. Interventions acceptability and feasibility will be evaluated using qualitative methods: undirected interviews with patients from the intervention group and 2 focus-groups, one with the peer support specialists and the other with the healthcare team.
Interventions
OTHERPeer support
: 1 hour individual session with a peer support specialist at 1, 3 and 5 months after baseline
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
non applicable
Intervention model description
a mixed methods randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients * With relapsing-remitting MS according to 2017 revised Mc Donald criteria * Attending medical consultation at Nantes University Hospital Neurology Department * For whom background drug therapy is needed (oral or injectable) * Who gave consent to participate in trial
Exclusion criteria
* Primary-progressive or secondary-progressive MS patients * Patients under protection of vulnerable adults measure or convicted * Patients not fluent in French * Patients with severe cognitive impairment, who may find difficult filling out questionnaires properly * Patients with a risk of follow-up interruption (move, nomadism…)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic adherence | 6 months | Description : score difference at baseline and 6 months of the " Necessity " and " Concerns " subscales of BMQ-Specific (Beliefs about medicines questionnaire) compared between control and intervention groups. A score, between 5 and 25, is calculated for each subscale by making a sum of the answers. Next, score difference between Necessity and Concerns (NCF) is calculated. NCF varies between -20 and +20. Value above 0 means that perceived treatment necessity exceeds treatment associated concerns. The more NCF comes close to +20, the better is the treatment risk/benefit balance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic compliance | 6 months | score difference at baseline and 6 months of MARS (Medication Adherence Rating Scale) questionnaire compared between control and intervention groups. A final score, between 5 and 25, is calculated by making a sum of the answers. If final score is 21 or above, or if every item is scored at least 4 points, the patient is deemed compliant. |
| Participants' quality of life | 6 months | score difference at baseline and 6 months of MusiQoL-MCAT (Multidimensional Computerized Adaptive Short-Form Quality of Life Questionnaire Developed and Validated for Multiple Sclerosis) compared between control and intervention groups. The score on each dimension is obtained by computing the mean of the item scores for that dimension. All dimension scores are linearly transformed to a 0 to 100 scale. A global index score is computed as the mean of the dimension scores. Higher scores indicate a higher level of quality of life. |
| Emotional wellbeing | 6 months | score difference at baseline and 6 months of HAD (Hospital Anxiety and Depression) questionnaire compared between control and intervention groups. A final score, between 0 and 21, is calculated by making a sum of the answers for each subscale. A subscale score \>8 denotes anxiety or depression. The higher the score is, the worse the severity of depression or anxiety symptoms. |
| Social support | 6 months | score difference at baseline and 6 months of SSQ6 (Social Support Questionnaire) compared between control and intervention groups. Two scores are calculated by making a sum of the answers in each dimension: N score (availability) ranges from 0 to 54 and S score (satisfaction) ranges from 6 to 36. Higher scores indicate a higher level of support availability or satisfaction. |
Countries
France
Contacts
STUDY_DIRECTORLeïla Moret, MD - PhD
Nantes University Hospital
PRINCIPAL_INVESTIGATORSandrine Wiertlewski, MD
Nantes University Hospital
Outcome results
None listed