Towards Digital Management of Paediatric Asthma

Официальное название

Towards Digital Management of Pediatric Asthma:a Pilot Study

Обзор

This pilot study aims to explore whether a digital approach to managing childhood asthma using connected inhalers and video consultations triggered by alerts from these devices - could work as well as standard in-person care. The connected inhalers track when children use their daily prevention medication and their rescue medication for asthma symptoms. If a child misses several days of prevention medication or uses their rescue inhaler frequently, their doctor receives an alert and can schedule a video consultation to adjust their treatment. Fifty children aged 4-12 years with asthma will participate for 8 months, with half using this digital system and half receiving usual care. The study will measure whether this new approach is practical and acceptable to families and doctors, and will look at its effects on asthma control, quality of life, and healthcare use. The results will help design a larger study to fully test if this digital approach could improve asthma care for children.

Подробное описание

Asthma is the most common chronic illness in children. In France, two-thirds of children have uncontrolled asthma, meaning they experience symptoms and occasional asthma attacks.

The digital revolution has enabled the development of connected devices, particularly smart inhalers, which collect objective information for assessing asthma from patients' homes. The Covid-19 pandemic has further accelerated the adoption of telemedicine. These new approaches represent a significant shift in paediatric asthma management, offering opportunities for more effective treatment methods.

As a precursor to a larger investigation, this pilot study hypothesises that digital asthma management using proactive remote care through telemedicine consultations triggered by connected device alerts may improve childhood asthma control compared to current management approaches.

Вмешательства

• Устройство Active telemonitoring using real-time data from digital inhalers.
  Telemonitoring system relying on the use of 2 digital inhalers FindAir ONE for pMDI, one for the controller the other for the reliever treatment. Active telemonitoring using real-time data from digital inhalers. Investigators will be alerted by email if a child: 1. fails to take his or her controller treatment for 4 continuous days and/or 2. uses \> 4 doses of reliever treatment over 24 hours 3. uses \< 12 doses of reliever treatment over 3 months (indication to decrease the controller treatm
• Другое Standard
  Standardized care + passive recording of asthma treatment use (controller and reliever treatments) using digital inhalers

Первичные конечные точки

• Change in asthma severity measured by the Composite Asthma Severity Index (CASI) [Срок оценки: At the inclusion visit (baseline) and 8 months (+/- 1 month) (end of study) in each group]

Вторичные конечные точки (12)

• Asthma control [Срок оценки: At the inclusion visit (baseline) and 8 months (+/- 1 month) (end of study) in each group]
• Severe exacerbations requiring oral steroids [Срок оценки: During the eight-month follow up period in each group]
• Severe exacerbations requiring emergency department visit and/or hospital admission. [Срок оценки: During the eight-month follow up period in each group]
• Children's lung function [Срок оценки: At the inclusion visit (baseline) and 8 months (+/- 1 month) (end study) in each group]
• Quality of life questionnaire [Срок оценки: At the inclusion visit (baseline) and 8 months (+/- 1 month) (end of study) in each group]
• Adherence [Срок оценки: During the eight-month follow up period in each group]
• Reliever treatment [Срок оценки: During the eight-month follow up period in each group]
• Number of teleconsultations/consultations [Срок оценки: During the eight-month follow up period in each group]
• Children participation [Срок оценки: During the eight-month follow up period in each group]
• Absenteeism [Срок оценки: During the eight-month follow up period in each group]
• Satisfaction of parents [Срок оценки: After 8 months (+/- 1 month) (end of study)]
• Satisfaction of doctors [Срок оценки: After 8 months (+/- 1 month) (end of study)]

Критерии участия

Критерии включения

• Aged 4 to 12, whose asthma has been diagnosed by a physician
• Followed up for their asthma by a pediatrician or pediatric pulmonologist
• With asthma severity corresponding to GINA grades 2, 3 or 4 (Global Asthma Initiative Guidelines)
• Whose controller and reliever treatments are administered using pressurized metered-dose inhalers (p-MDIs)
• With social security
• Whose parents or legal guardian(s):

• Have given their written and informed consent for their child's participation and their participation,
• Have a smartphone in the household that can download the application and is compatible with it,
• Are capable, in the opinion of the investigator, of understanding the use of the mobile application and module FRENCH CARE specifically dedicated to the research and the digital inhalers provided.

Non-inclusion Criteria:

• Patients with another pathology that could interfere with the evaluation of the endpoints (e.g, bronchopulmonary dysplasia, cystic fibrosis, etc.)
• Patients whose parents or legal representative(s) are, in the opinion of the investigator, unable to understand the purpose of the study and/or express their consent.
• Patients benefiting from State Medical Aid

Критерии исключения

\- Patient who did not use the system within 15 days of the inclusion visit

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Hôpital Necker Enfants Malades AP-HP — Paris

Идентификаторы

NCT: NCT06902766 · APHP211434 · ID-RCB Number:2022-A02649-34

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗