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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура MoDIDol intervention
  Multidisciplinary mobile intervention system specialising in pain management for patients with moderate to severe intellectual development disorders, isolated or associated with ASD or multiple disabilities. Treatment recommendations, pain assessment, training in scales, follow-up consultations every 6 weeks for 6 months, continued if the situation is not resolved, call at 12 months.

Первичные конечные точки

• Global Clinical Improvement at 6 months [Срок оценки: From baseline to the end of 6 months of treatment with the MoDIDol system, assessed up to 6 months (T3)]

Вторичные конечные точки (12)

• Global Clinical Improvement at 3 months [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system]
• Pediatric Pain Profile Pain Category Change [Срок оценки: 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 [Срок оценки: Baseline (T1)]
• Pediatric Pain Profile Pain Behavior Profiles [Срок оценки: Baseline (T1)]
• Behavioral Disturbance Evolution [Срок оценки: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system.]
• PedsQL Patient Quality of Life Scores [Срок оценки: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system]
• PolyQoL Patient Quality of Life Scores [Срок оценки: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system]
• Sleep Quality Scores [Срок оценки: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system]
• Parental Quality of Life [Срок оценки: Baseline (T1), after 3 months (T2), and 6 months (T3) of treatment with the MoDIDol system]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• CHU de Brest - Hôpital Morvan — Brest

Идентификаторы

NCT: NCT07302048 · 29BRC24.0282

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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