Cohort Multiple Randomized Controlled Trial in Pediatric Asthma
ConditionPediatric Asthma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-18
SponsorMattienne van der Kamp
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Is 4 to 18 years old
Is patient at the children's department at Medisch Spectrum Twente at moment of inclusion
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
video directly observed therapy (vDOT)
Other interventionThe first intervention of within the CIRCUS study is video directly observed therapy (vDOT). The intervention consists of taking recording of daily inhalation use and receiving four feedback sessions of an asthma nurse based on these home recordings.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Intervention armExperimental treatment 1 intervention
Group B: Cohort control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Asthma control
C-ACT/ACT: (Childhood) Asthma Control Test
Time frame
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)2
Pediatric Asthma Quality of Life
Pediatric Asthma Quality of Life Questionnaire (PAQLQ)
Time frame
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)3
Quality of care
CSQ-4: Client Satisfaction Questionnaire.
Time frame
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)4
Self-management capacity
PAM-13: patient activation measurement
Time frame
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Mattienne van der Kamp
Lead sponsor
Medisch Spectrum Twente
Sponsor institution
Source ClinicalTrials.gov