Cohort Multiple Randomized Controlled Trial in Pediatric Asthma: Infrastructure to Assess the Long- and Short-term Effects of (eHealth) Interventions.
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mattienne van der Kamp
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Pediatric Asthma Quality of Life
概览
简要总结
The overarching goal of this study is to optimize pediatric asthma care and to continuously evaluate variations/innovations of the care (including transformation to remote eHealth care).
Primary Objectives within cmRCT cohort:
- Provide a framework for multiple randomized (eHealth) interventions for asthmatic children
- Generate short- and long-term data on Quality of life (QoL), asthma outcomes (asthma control, lung function), quality of care, self-management capacity, healthcare use, and therapy compliance in a representative secondary care pediatric asthma cohort.
Secondary Objectives within cmRCT cohort:
- Evaluate current pediatric asthma care at the Pediatric department of Medisch Spectrum Twente, in order to explore possible improvements for the pediatric asthma care.
- Compare the short and long-term asthma outcomes between the eHealth care path and the outpatient care path.
- Compose patient risk profiles that include both personal, clinical and exposome markers and clinical asthma endpoints (for example clinical admission/exacerbations).
详细描述
Rationale: Testing of eHealth interventions seems crucial since eHealth provides possibilities to obtain a real-time and objective view of asthma symptoms. Traditional randomized controlled trials(RCTs) face challenges in evaluating the effect of multiple eHealth components separately and in the long process of translating intervention ideas into funded research protocols, which may risk the eHealth intervention becoming outdated.
Objective
This study aims to provide a framework to assess the effect of (eHealth) interventions and generate short- and long-term data on clinical and patient-reported outcomes of asthmatic children using a cohort multiple Randomized Controlled Trial (cmRCT) design.
Study design: The CIRCUS study is a cmRCT designed to test multiple eHealth interventions in eligible asthmatic children (4-18 years old, treated in MST) within a cohort. Observational clinical data is collected of these children and both the children and their parents regularly complete questionnaires. In addition, a random selection of eligible children is approached for participation in interventions while the non-selected children remain in the control group.
Study population: Included children are 4-18 years old, diagnosed with asthma following the Global Initiative for Asthma (GINA) criteria and treated in Medisch Spectrum Twente at Enschede.
Main study parameters/endpoints: Primary outcome measures are Quality of life(QoL), asthma outcomes(asthma control, lung function), quality of care, self-management capacity, healthcare use, and therapy compliance.
Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: Children and parents fill out questionnaires on a monthly and half-yearly basis. The questionnaires include: (C)-ACT, PAQLQ, CSQ-4, and PAM-13. In consultation with the patient panel we chose the shortest validated questionnaires to reduce the study burden. Other data (for example healthcare use) is collected by the researchers. No relevant risks were found in the risk analysis. We chose to use this group of children in this study as asthma management in children differs from that in adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
The masking is dependent of the future interventions.
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is 4 to 18 years old
- •Is patient at the children's department at Medisch Spectrum Twente at moment of inclusion
- •Is diagnosed with asthma by a pediatrician following the Global Initiative for Asthma(GINA) guidelines 2022 \[8\]:
- •\*Medical history fitting asthma diagnosis:
- •Based on (typical) symptoms: (nighttime) wheezing, dyspnea, coughing (triggered by either viral infections, exercise, allergens or weather changes)
- •(Possibly) supplemented with a family history/atopy
- •\*Spirometry variable expiratory airflow limitation by at least one of these criteria:
- •FEV1/FVC reduced compared to lower limit of normal(Z-score ≤ -1.64)
- •Positive bronchodilator responsiveness(increase FEV1\>12%)
- •Positive Exercise Challenge Test (ECT)(decrease FEV1≥ 13%)
排除标准
- •The child and/or parent(s) has/have insufficient command of the Dutch language resulting in the insufficient ability to understand and/or answer questions
结局指标
主要结局
Pediatric Asthma Quality of Life
时间窗: once per 6 months (until the patient turns 18 years old, has no astma diagnosis anymore or is no longer under treatment of the MST hospital, whichever came first, assessed up to 168months)
Pediatric Asthma Quality of Life Questionnaire (PAQLQ)
Asthma control
时间窗: monthly (until the patient turns 18 years old, has no astma diagnosis anymore or is no longer under treatment of the MST hospital, whichever came first, assessed up to 168months)
C-ACT/ACT: (Childhood) Asthma Control Test
Quality of care
时间窗: once per 6 months (until the patient turns 18 years old, has no astma diagnosis anymore or is no longer under treatment of the MST hospital, whichever came first, assessed up to 168months)
CSQ-4: Client Satisfaction Questionnaire.
Self-management capacity
时间窗: once per 6 months (until the patient turns 18 years old, has no astma diagnosis anymore or is no longer under treatment of the MST hospital, whichever came first, assessed up to 168months)
PAM-13: patient activation measurement
Air quality
时间窗: daily (until the patient turns 18 years old, has no astma diagnosis anymore or is no longer under treatment of the MST hospital, whichever came first, assessed up to 168months)
Hourly data on: Nitrogen dioxide(NO2), Nitric oxide(NO), Ozone(O3), Particulate matter(PM10), Particulate matter(PM2.5), Ultra Fine Particles(UFP) Carbon monoxide(CO2), Sulpher dioxide(SO2) Pollencount (daily): birch, grasses etc.
Healthcare use
时间窗: continuous (until the patient turns 18 years old, has no astma diagnosis anymore or is no longer under treatment of the MST hospital, whichever came first, assessed up to 168months)
hospital admissions, outpatient visits, telephonic consultations, diagnostics,
Wheather data
时间窗: daily (until the patient turns 18 years old, has no astma diagnosis anymore or is no longer under treatment of the MST hospital, whichever came first, assessed up to 168months)
Wheather data (hourly): Temperature, humidity, rainfall
Pollen
时间窗: daily (until the patient turns 18 years old, has no astma diagnosis anymore or is no longer under treatment of the MST hospital, whichever came first, assessed up to 168months)
Pollencount (daily): Treepolls (Birch, Hazel, Alder, etc...) \& bushes/grasspolls (grass, worm-wood, ambrosia, goose grass etc....)
Medication delivery
时间窗: continous (until the patient turns 18 years old, has no astma diagnosis anymore or is no longer under treatment of the MST hospital, whichever came first, assessed up to 168months)
LSP list via pharmacy of Medisch Spectrum Twente * Name medicine * Date of issue * Dose * Expected period of use * Quantity provided
次要结局
未报告次要终点
研究者
Mattienne van der Kamp
dr.
Medisch Spectrum Twente