Impact and Determinants of Success of a Mobile Multidisciplinary Intervention System Specialized in Pain Management for Patients With Moderate to Severe Intellectual Development Disorder, Isolated or Associated With an ASD or Multiple Disability - MoDIDol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Global Clinical Improvement at 6 months
研究概览
简要总结
Pain is described by patients with a Neurodevelopmental Disorder (NDD), including Autism Spectrum Disorder (ASD), Intellectual Development Disorder (IDD) or multiple disabilities, and the family as one of the main associated disorders; its management is also one of the main concerns of families and professionals. At present, there is no validated and tested pain management system in populations facing complex pain situations. In response to the lack of a pain management services, a multi-disciplinary mobile team was set up in September 2022 at the Brest University Hospital (Mobile Pain Handicap Team Intellectual Disability 0-25 years; MoDIDol). This team offers a specific protocol for the assessment and management of pain that takes into account the social and family environment, the living context and the clinical characteristics of patients (children, adolescents and young adults (0-25 years) with IDD, ASD or multiple disabilities). The team includes at least one paediatrician specialising in the assessment and treatment of pain and a nurse, and travels to patients' usual living environments.
详细描述
The MoDIDol team intervenes at the request of parents or professionals in complex situations involving pain or behavioural problems suggestive of pain, unresolved despite previous treatment. Parents and professionals learn about the MoDIDol team through flyers and information provided by associations and organisations supporting people with disabilities (associations, CRDI, etc.).
Once they are included in the study and after consent has been signed, multidisciplinary follow-up consultations are carried out by the MoDIDol team for pain management (every 6 weeks).
At the same time, three data collection sessions are planned for the participants, 3 months apart. Questionnaires are completed at each point by dedicated study staff. Interviews are conducted at 6-month intervals among a representative sample of professionals and parents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from birth up to 24 years inclusive (i.e., under 25 years old)
- •Medical diagnosis of intellectual disability (ID), isolated or associated with autism spectrum disorder (ASD), developmental disorder (DD), or profound multiple disabilities, based on international classification systems (ICD-11 or DSM-5)
- •Confirmed probable or definite pain diagnosis, as validated by the MoDIDol team
- •PGIC score ≥ 3
- •Living in or receiving care in the departments of Finistère, Côtes-d'Armor, or Morbihan
- •Written informed consent provided by parents, legal guardians, or holders of parental authority, authorizing data collection for research and publication purposes
- •Affiliated with or benefiting from a French national health insurance scheme
排除标准
- •More than three places of residence and/or care settings
- •Parents or legal guardians who do not have sufficient language or comprehension skills to provide informed consent or complete study questionnaires
结局指标
主要结局
Global Clinical Improvement at 6 months
时间窗: From baseline to the end of 6 months of treatment with the MoDIDol system, assessed up to 6 months (T3)
The primary outcome is the patient's global clinical improvement as perceived by family caregivers and/or institutional professionals, using the Patient Global Impression of Change (PGIC) scale after 6 months of care provided by the MoDIDol team. Improvement is defined as a PGIC score of 1 or 2 out of 7. scale from 1 to 7, higher scores mean worse outcome.
次要结局
- Global Clinical Improvement at 3 months(From baseline to the end of 3 months of treatment with the MoDIDoL system, assessed up to 3 months (T2))
- Non Communicating Children's Pain Checklist (NCCPC) Pain Intensity Scores at T1, T2, and T3(Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system.)
- Pediatric Pain Profile (PPP) Pain Intensity Scores at T1, T2, and T3(Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system.)
- Non Communicating Children's Pain Checklist (NCCPC) Pain Category Change(Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system)
- Pediatric Pain Profile Pain Category Change(Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system)
- Non Communicating Children's Pain Checklist (NCCPC) Pain Behavior Profiles(Baseline (T1))
- Pediatric Pain Profile Pain Behavior Profiles(Baseline (T1))
- Behavioral Disturbance Evolution(Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system.)
- PedsQL Patient Quality of Life Scores(Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system)
- PolyQoL Patient Quality of Life Scores(Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system)
- Sleep Quality Scores(Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system)
- Parental Quality of Life(Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system)
- Parental Stress(Baseline (T1), 3 months (T2), and 6 months (T3))
- Determinants of Success(From baseline to the end of 6 months of treatment with the MoDIDol system, assessed up to 6 months (T3))
- Pain Mechanism, Localization, and Etiology(Pain mechanism, location and etiology are determined at T1 but can be revised during the 6 months patient follow up)
- Analgesic and Behavioral Treatments(From baseline to the end of 3 months (T2) and 6 months (T3) of treatment with the MoDIDol system)
- Psychometric Properties of Non Communicating Children's Pain Checklist (NCCPC) Scale(Through study completion, an average of 6 months after baseline.)
- Psychometric Properties of Pediaric Pain Profile Scale(Through study completion, an average of 6 months after baseline.)
- Qualitative Interviews with Parents and Professionals(Baseline (T1) and after 6 months (T3) of treatment with the MoDIDol system)