Peer Support Impact on Therapeutic Adherence in Patients With Multiple Sclerosis: a Mixed Methods Randomized Controlled Trial Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Therapeutic adherence
研究概览
简要总结
A mixed methods randomized controlled trial pilot study to assess peer support impact on relapsing-remitting multiple sclerosis patients' therapeutic adherence.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
non applicable
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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…)
研究组 & 干预措施
Control group
30 MS (Multiple sclerosis, relapsing-remitting) patients
Experimental group
30 MS (Multiple sclerosis, relapsing-remitting) patients
干预措施: Peer support (Other)
结局指标
主要结局
Therapeutic adherence
时间窗: 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.
次要结局
- Therapeutic compliance(6 months)
- Social support(6 months)
- Participants' quality of life(6 months)
- Emotional wellbeing(6 months)