NCT06052384招募中不适用
Optimisation du Parcours de Soins Des Patients Atteints de Douleurs Chroniques : étude randomisée évaluant l'intérêt de l'intégration Des spécialistes du Sommeil
Centre Hospitalier Emile Roux1 个研究点 分布在 1 个国家目标入组 664 人开始时间: 2023年12月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 664
- 试验地点
- 1
- 主要终点
- The primary endpoint is the Mental Composite Score (MCS) of the Short Form 36 Health Survey (SF-36) questionnaire
研究概览
简要总结
DOLOREPIT is an interventional, RIPH 2, multicenter, randomized, controlled, open-label study comparing two care pathways for the management of patients with chronic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First consultation at the pain management center
- •Patient with chronic pain as defined by the "Haute Autorité de Santé". The pain must have several of the following characteristics:
- •Persistence or recurrence
- •Duration beyond what is usual for the presumed initial cause, especially if the pain has been evolving for more than 3 months;
- •Inadequate response to treatment;
- •Important and progressive deterioration of the patient's functional and interpersonal abilities in activities of daily living at home, school, or work due to the pain.
- •Patients with chronic primary pain (according to the typology defined by the International Classification of Diseases-11) and classified into one of the 4 following categories:
- •Chronic generalized pain
- •Complex regional pain syndrome
- •Chronic primary headache or orofacial pain
- •Chronic primary musculoskeletal pain
- •Pittsburgh Sleep Quality Index (PSQI) must be completed by the patient and the score must be available (for randomization purposes)
- •Have access to an internet connection as a self-administered questionnaire is to complete online, and at least have access to the online platform for CBT treatment if insomnia is detected
- •Affiliation to a French social security system
- •Free informed consent
排除标准
- •Patients undergoing cancer treatment or who have completed treatment within the last 2 years
- •Patient with a chronic inflammatory disease (e.g. rheumatoid arthritis, ankylosing spondylitis, chronic inflammatory bowel disease, Horton's disease, Wegener's disease, myositis, Still's disease, lupus erythematosus, etc.)
- •Immunocompromised patient
- •Patient with severe psychiatric pathology that does not allow study follow-up (at the discretion of the investigator)
- •Patient already treated for a sleep disorder by a sleep specialist (the only prescription of hypnotics is not considered as a criterion of non-inclusion)
- •Patient follow-up difficult (for geographic motives or other reasons)
- •Patient under judicial protection of incapable adults or guardianship
- •Refusal to participate in the research
研究组 & 干预措施
Reinforced sleep program
Experimental
standard pain management + sleep disorders management
干预措施: Standard pain management combined with sleep disorder management (Other)
Standard care
No Intervention
Control group: standard pain management
结局指标
主要结局
The primary endpoint is the Mental Composite Score (MCS) of the Short Form 36 Health Survey (SF-36) questionnaire
时间窗: Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group)
It's a scientifically validated multidimensional scale that provides a generic score for assessing quality of life, regardless of pathology, age or gender. The 36 items of this questionnaire evaluate 8 dimensions: physical activity; limitations due to physical condition; physical pain; perceived health; vitality; life and relationships with others; limitations due to physical condition; psychological health, as well as a separate dimension on the evaluation of perceived health compared to one year earlier. An average score range from 0 to 100 and can be calculated according to an established algorithm. A high score means good health and absence of pain.
次要结局
- The score of the French version of the McGill pain questionnaire (MPQ)(Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group))
- The cost-utility ratio for the medico-economic impact of the care pathway(Change from baseline (Day 0) at Month 6)
- For the experimental group, the average apnea-hypopnea index (AHI)(at start of ventilation (continuous positive airway pressure), then for periods Month 3-Month 6 and Month 6-Month 12)
- For the experimental group, the score of the insomnia severity index (ISI)(At the 1st sleep consultation (Month 1) then at Month 6 and Month 12)
- The score of the French version of the McGill pain questionnaire (MPQ)(Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group))
- The cost-utility ratio for the medico-economic impact of the care pathway(Change from baseline (Day 0) at Month 6)
- For the experimental group, the score of the insomnia severity index (ISI)(At the 1st sleep consultation (Month 1) then at Month 6 and Month 12)
- The score of the French version of Pittsburgh Sleep Quality Index (PSQI)(Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group))
- For the experimental group, the average apnea-hypopnea index (AHI)(at start of ventilation (continuous positive airway pressure), then for periods Month 3-Month 6 and Month 6-Month 12)
- The Physical Composite Score (PCS) of the Short Form 36 Health Survey (SF-36) questionnaire(Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group))
- The score of the French version of the Brief Pain Inventory (BPI).(Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group))
- The score of Hospital anxiety and depression scale (HADS)(Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group))
- The score of the Epworth Sleepiness scale(Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group))
- The score of the Patient Global Impression of Change (PGIC) scale(Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group))
- The drug consumption, particularly analgesics, antidepressants, benzodiazepines and related hypnotics(Change from baseline (Day 0) at Month 6 (and at Month 12 only for the experimental group))
- The score of the International Restless legs syndrome (IRLS) questionnaire(At the 1st sleep consultation (Month 1) then at Month 6 and Month 12)
研究者
研究点 (1)
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