CIRCUS cohort: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…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
CIRCUS study:
n/a
MIME study:
The secondary endpoint is the inhalation technique score within the
intervention group.
Background summary
CIRCUS cohort:
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protocols, which may risk the eHealth intervention becoming outdated.
MIME study:
Asthma is one of the most common chronic diseases in childhood. One of the
problems that can lead to poor symptom control is inadequate inhaler technique.
Despite these few studies reporting on the short term effect of remote
observation of therapy, no studies report on long term effects of remote
inhaler technique training. The research gap therefore lies in the follow-up of
inhaler technique and asthma outcomes after a remote inhaler technique
intervention.
Study objective
CIRCUS cohort:
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.
MIME study:
This study aims to evaluate the long-term effects of video Directly Observed
Therapy (vDOT) compared to regular care on the asthma control in children with
asthma.
Study design
CIRCUS cohort:
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.
MIME study:
This study is a randomized study, designed as the first intervention of the
CIRCUS cohort multiple randomized controlled trial. Children in the
intervention group start with an observational week of inhalation recording.
Thereafter they receive 6 weeks of intervention, followed by 3 months without
intervention. Further follow-up will continue within the CIRCUS cohort. The
control group consist of other cohort participants and is blinded
Intervention
Intervention 1 of the cmRCT: (attached as appendix protocol C):
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.
Study burden and risks
CIRCUS study:
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.
MIME study:
Asthma is the most common chronic disease in childhood. And within this
population incorrect inhalation technique of required maintenance medication
(or reliever medication) is of frequent occurrence, causing undertreatment,
uncontrolled asthma and higher risk of exacerbations. Moreover, asthma
characteristics in children differ from those in adults. It is therefore
important to investigate the inhalation technique, try to improve it and try to
maintain a good inhalation technique throughout childhood. Moreover, individual
children may benefit from the extra attention and education with regards to the
inhaler technique. The burden of this study includes the recording of
medication intakes for six weeks once daily (10*7=70x +-10seconds * 15minutes),
10 times filling in the (c)-ACT questionnaire (10*3min=30min), and 4 online
feedback sessions of 15minutes (1hour). These measurements are non-invasive and
no risks are associated with participation.
Koningsplein 1
Enschede 7512KZ
NL
Koningsplein 1
Enschede 7512KZ
NL
Listed location countries
Age
Inclusion criteria
CIRCUS cohort (n=300)
-4 to 18 years old
-patient at the children*s department at Medisch Spectrum Twente at moment of
inclusion
-diagnosed with asthma by a pediatrician following the Global Initiative for
Asthma(GINA) guidelines 2022:
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
AND
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%)
Excessive variation in lung function (LF) between tests from different dates
(variation FEV1>12% pred)
For the MIME intervention (n=106, of which 30 intervention group, 76 control
group):
• Participating in CIRCUS cohort & consented willingness to participate in
interventions.
• ACT <20
• Using controller inhalation therapy through one of the most common inhaler
device types for children (aerosols with spacer, breath actuated aerosol
(Redihaler or Autohaler), dry powder inhalator (Nexthaler, Diskus or Ellipta)
for asthma at least once daily.
Exclusion criteria
For the CIRCUS cohort:
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
For the MIME study:
• An appointment with the asthma nurse for inhalation instruction has already
been scheduled.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCTvolgt |
| CCMO | NL85668.100.23 |