Peer support impact on therapeutic adherence in patients with multiple sclerosis: a mixed-methods pilot trial protocol

The outcomes will relate to our two objectives: peer support impact on MS patients and feasibility/acceptability of the study.

Peer support impact

As PAIR-SEP is a pilot study, all impact outcomes are exploratory and are therefore on the same level, however therapeutic adherence was chosen as primary for the sake of the sample size calculation. These preliminary results will be used to inform the protocol of a future multicentre randomised controlled trial. All impact outcomes will be assessed using difference in questionnaire scores between baseline and 6 months in both groups.

Therapeutic adherence will be explored using the mean score difference at baseline and after 6 months of the ‘Necessity’ and ‘Concerns’ subscales of the BMQ (Beliefs about Medicines Questionnaire) Specific scale. The BMQ has been validated as a screening test for low therapeutic adherence in several chronic diseases22 23 and has recently been used in MS patients.24 25 This questionnaire consists of two scales, BMQ-General and BMQ-Specific, which can be used separately. The BMQ-Specific scale assesses treatment-associated beliefs, according to 10 items and two subscales: treatment necessity and treatment concerns. The items are scored on a 5-point Likert scale ranging from ‘Totally agree’ (one point) to ‘Totally disagree’ (five points). A final score, ranging between 5 and 25, is calculated for each subscale by summing the answers to each item. The psychometric properties of this scale have been validated in several populations, mostly chronic patients (asthma, renal failure, psychiatric pathologies, …).23 26 Cronbach’s alpha coefficients of the Specific-Necessity and Specific-Concerns subscales range, respectively, from 0.55 to 0.86 and from 0.63 to 0.80 depending on the population studied.23 A validated French version, published by Fall et al, in 2014 is available.27

According to the Necessity-Concerns framework (N CF), the score of the Concerns subscale can be subtracted to the score of the Necessity subscale to compute an indicator called the NCF. The NCF varies between −20 and +20, and a positive value indicates that the perceived treatment necessity exceeds treatment associated concerns. The closer the NCF comes to +20, the better risk/benefit balance of the treatment is. Several studies have showed that patients with a higher perceived treatment necessity or lower treatment associated concerns (as assessed by BMQ-Specific) are more prone to follow their physician’s recommendations.25 28 29

Therapeutic compliance will be assessed by the mean score difference at baseline and after 6 months of the Medication Adherence Rating Scale (MARS) questionnaire. MARS is a validated tool to assess therapeutic compliance in chronically ill patients.30 31 The short version consists of 5 items, scored on a Likert scale ranging from 1 to 5. A final score, between 5 and 25, is calculated by summing the answers to the items. If the final score is 21 or above, or if every item is scored at least four points, the patient is deemed compliant. The MARS questionnaire was adapted and validated in French by Misdrahi et al in 200432 and then by Fond et al in 2017.31

Quality of life will be assessed by the mean score difference at baseline and after 6 months of the MusiQoL-MCAT. This short questionnaire was specifically designed for MS patients, with a validated French translation and good psychometric properties.33 34 It consists of 31 items, divided in nine dimensions: activities of daily living (eight items), psychological well-being (four items), symptoms (four items), relationships with friends (three items), relationships with family (three items), relationships with healthcare system (three items), sentimental and sexual life (two items), coping (two items), and rejection (two items). Each item is scored on a 6-point Likert scale, ranging from ‘never/not at all’ (one point), to ‘always/very much’ (five points) with an extra value for ‘not applicable’ (six points). For each individual, the score for each dimension is obtained by computing the average score of the related items. All dimension scores are linearly transformed to a 0 to 100 scale and an overall average score is computed. Higher scores indicate a higher level of quality of life.

Emotional well-being will be assessed using the mean score difference at baseline and after 6 months of the HAD (Hospital Anxiety and Depression) questionnaire. The HAD scale allows for anxiety and depressive disorders screening.35 It consists of two subscales (anxiety and depression) of seven items each. The possible score for each item ranges from 0 to 3, and a subscale score superior to eight denotes anxiety or depression. The higher the score is, the higher the severity of the symptoms. The HAD questionnaire was created in 1983 and was used in several chronic diseases, including MS.36 37 Its French translation was made by Lépine et al and validated by Ravazi et al in 1989.38 39

Social support will be assessed using the mean score difference at baseline and after 6 months of the 6-item Social Support Questionnaire (SSQ6). Social support can be assessed in two ways: objective (received social support) or subjective (perceived social support). Perceived social support refers to how individuals perceive friends, family members and others as sources available to provide material, psychological and overall support during times of need. Studies on peer support impact on chronic patients show that one of the main benefit of peer support is on perceived social support.10 11 40

SSQ6 is a 6-item questionnaire designed to measure perceived social support using two dimensions: satisfaction and availability of support. This questionnaire is a shortened version of the original Social Support Questionnaire designed by Sarason et al in 1983.41 It has been translated and validated in French.42 Each item is a question that solicits a two-part answer: part 1 asks participants to list from 0 to 6 people that fit the description of the question, and part 2 asks participants to indicate how satisfied they are with the support provided by each of these people, using a 6-point Likert scale (6: ‘very satisfied’ to 1: ‘very dissatisfied’). Two scores are then calculated by summing the answers within each dimension: The N score (availability) ranges from 0 to 54 and the S score (satisfaction) ranges from 6 to 36.

Focus groups

Two separate focus groups will be organised to better understand what the study entailed for the healthcare team and peer helpers.

A focus group with only peer helpers will allow the exploration of several aspects of the study: recruitment, training, coaching during intervention, study organisation and unfolding, drivers and barriers to participate in the study as a chronic patient themselves. Peer helper’s feedbacks will be crucial to improve the programme, as peer support interventions have to be tailored to the needs of not only MS patients but also peer helpers, as they also experience physical and psychological consequences of the disease.

Another focus group will be organised with the healthcare professionals of the hospital’s Neurology Department. Their feedback on the conduct of the study will be collected, exploring themes such as the introduction of the peer helpers to the team, teamwork with peer helpers, work relationship between healthcare team and peer helpers, study impact on the team and study endorsement. A good relationship between peer helpers and the Neurology healthcare team is essential, as malfunctions could jeopardise the study.

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