Evaluate the effect of pediatric asthma eHealth care on the healthcare utilization, asthma outcomes and quality of life.
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This study aims to evaluate the effect of pediatric asthma eHealth care on the
amount, type and costs of healthcare utilization. The essence of this study is
to evaluate the difference in healthcare utilization by the use of eHealth.
Secondary outcome
1) To evaluate the effect of pediatric asthma eHealth care on the asthma
outcomes and quality of life.
2) To assess how long the learning effects of the healthcare utilization,
asthma outcomes and quality of life effects after 3 months of follow up in
theof eHealth interventions compared to the control groupon asthma outcomes.
healthcare utilization last and to assess the time to first healthcare events
in the follow-up period in both the intervention and control group. (survival
analysis).
3) To assess the effect of eHealth interventions (i.e. education on
self-management, treatment change or providing a personalized action plan) on
the asthma outcomes, such as lung function and asthma control score.
4) To assess the effect of personalized real-time monitoring and education of
inhalation (based on objective smart inhaler data) on the inhalation
technique/adherence.
5) To investigate the effect of (via eHealth communication) supervised
nebulizer therapy (with Sami the Seal). (amount of events, % solved at home, %
that still result in referral to hospital)
6) To correlate monitoring parameters (nocturnal symptoms, lung function,
oxygen saturation, cough/wheeze, medication use and air parameters (indoor +
outdoor + pollen) univariately and multivariate with reported symptoms and
asthma control.
7) To assess the perception of dyspnea in children by correlating the
self-reported dyspnea with the visual analogue scale versus home-measured lung
function.
8) To analyze the preluding period before an asthma exacerbation for predictors
in the home-measured signals using predictive modelling.
9) To explore the feasibility and acceptance of the monitoring devices for
home-use in children.
10) To identify the patient characteristics of children with successful eHealth
care outcomes.
Background summary
Asthma is one of the most common chronic diseases in children. Pediatric asthma
management is focused on control of asthma symptoms, enabling patients to fully
participate in daily life. The Dutch lung alliance states that regular
follow-up of asthma control is needed to prevent disease deterioration and
boost quality of life. Previous home-monitoring & eHealth studies show
potential in ambulatory pediatric asthma care, however one-by-one could not
always provide a good correlation with asthma control for all asthmatic
children. The primary objective of the ALPACA study is to combine the most
potential home-monitoring measures and the optimized eHealth approaches to
evaluate the effect of pediatric asthma eHealth care on the healthcare
utilization asthma outcomes and quality of life.
Study objective
Evaluate the effect of pediatric asthma eHealth care on the healthcare
utilization, asthma outcomes and quality of life.
Study design
The ALPACA study has a prospective randomized control interventional design,
including a follow-up period to evaluate learning effect. The study is divided
into two phases of 3 months; In the first phase subjects are randomized to
either eHealthcare and observational home-monitoring or only observational
home-monitoring during regular care. The second phase is a follow-up period of
3 months to evaluate the follow-up effects of eHealth care compared to the
control group and how long these effects can last (survival analysis). The
study makes use of an intention-to-treat analysis.
Intervention
eHealth home-monitoring of respiratory physiology and online communication.
Study burden and risks
This study is designed in a way to optimize the trade-off between maximizing
the diagnostic value and to minimize the burden. The monitoring devices are
chosen based on their feasibility in children, size and unobtrusiveness. This
study asks participants to actively blow a lung function and fill in the short
C-ACT questionnaire weekly for a period of 6 months. Other monitoring does not
require their attention or is performed as needed. Moreover parents and
children are interviewed about their experiences. This research does not have
any significant safety risks for the subjects. Both the participants and the
healthcare professionals have the option the pre-maturely end the participation
if any risk may arise (due to i.e. non-compliance to monitoring, loosing
contact, failure of technology or any other reason). Moreover children and
parents can always use the escape route, which is the regular path of
healthcare. Participants may benefit from gaining more insight into their
asthma control and increased self-management. The study is group-related as it
specifically investigates the effect of eHealth on pediatric asthma outcomes
and it could therefore not be conducted without the participation of subjects
belonging to the group in question.
High Tech Campus 34
Eindhoven 5656 AE
NL
High Tech Campus 34
Eindhoven 5656 AE
NL
Listed location countries
Age
Inclusion criteria
o Children with moderate-to-severe asthma.
o Children in the age group from 4 up to and included 11 years old.
o Children living in a house with WIFI
Exclusion criteria
o Prior participation in eHealth care trial.
o Children/Parents with an inability to understand or speak Dutch.
o Children with divorced parents or other reasons that causes them to be less
than 80% on the same living address.
o Children of whom family members have already participated in this trial.
o Children using an inhaler that is not compatible with the FindAir smart
inhaler cap, which cannot be replaced by a compatible alternative.
o Children for whom it is not possible to perform at least one of the two
discontinuous dyspnea assessment (lung function/pulse oximetry).
o Children with chronic diseases other than asthma (i.e. inflammatory bowel
disease, behavioral disorders, mental retardation).
o Children with currently displaying COVID-19-related symptoms, namely a fever,
cough and/or difficulty breathing (during inclusion) or being infected with
COVID-19 in the past 14days.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL74559.100.22 |