Peer Support Impact on Therapeutic Adherence in Patients With Multiple Sclerosis

Multiple Sclerosis, Relapsing-remitting Clinical Trial

— PAIR-SEP  

Official title:

Peer Support Impact on Therapeutic Adherence in Patients With Multiple Sclerosis: a Mixed Methods Randomized Controlled Trial Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05519553
• Other study ID #: RC22_0175
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: March 1, 2026

Study information

• Verified date: August 2022
• Source: Nantes University Hospital
• Contact: Leïla MORET, MD - PhD
• Phone: 02.40.84.69.24
• Email: leila.moret[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A mixed methods randomized controlled trial pilot study to assess peer support impact on relapsing-remitting multiple sclerosis patients' therapeutic adherence.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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…)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Other:
• Peer support
: 1 hour individual session with a peer support specialist at 1, 3 and 5 months after baseline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic adherence	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.	6 months
Secondary	Therapeutic compliance	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.	6 months
Secondary	Participants' quality of life	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.	6 months
Secondary	Emotional wellbeing	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.	6 months
Secondary	Social support	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.	6 months