AmbuLatory Pediatric Asthma CAre

Asthma in Children Clinical Trial

Official title:

ALPACA : The Effect of Online Monitoring and Communication on the Quality and Quantity of Pediatric Asthma Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05517096
• Other study ID #: ICBE-S-000177
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: August 2022
• Source: Philips Electronics Nederland B.V. acting through Philips CTO organization
• Contact: I Geven, master Science
• Phone: +31646545735
• Email: inge.geven[@]philips.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The ALPACA study has a prospective randomized control interventional design, including a follow-up period to evaluate follow-up effects. The study is divided into two phases of 3 months using eHealth and observational monitoring.

Description:

The ALPACA study has a prospective randomized control interventional design, including a follow-up period to evaluate follow-up effects. The study is divided into two phases of 3 months; In the first phase subjects are randomized to either eHealth care (use of a communication portal including the weekly entry of SpO2, spirometry results and ACT) and explorative observational home-monitoring or only explorative observational home-monitoring during regular care. The second phase is to evaluate the effects of eHealth care compared to the control group after a follow-up period of 3 months, and the time to healthcare events during follow-up in both groups (survival analysis). The study makes use of an intention-to-treat analysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 1, 2024
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 11 Years

Eligibility

Inclusion Criteria:

• Children with moderate-to-severe asthma.
• Children in the age group from 4 up to and included 11 years old.

Exclusion Criteria:

• Children living in a house without WIFI.
• Prior participation in eHealth care trial.
• Children/Parents with an inability to understand or speak Dutch.
• Children with divorced parents or other reasons that causes them to be less than 80% on the same living address.
• Children of whom family members have already participated in this trial.
• Children for whom it is not possible to perform at least one of the two discontinuous dyspnea assessment (lung function/pulse oximetry).
• Children using an inhaler that is not compatible with the FindAir smart inhaler cap, which cannot be replaced by a compatible alternative.
• Children with chronic diseases other than asthma (i.e. inflammatory bowel disease, behavioral disorders, mental retardation).
• Currently displaying COVID-19-related symptoms, namely a fever, cough and/or difficulty breathing (during inclusion).
• Having been positively tested as infected with COVID-19 in the past 14 days

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Other:
• E-Health
In the intervention phase asthma care is provided on an at-needed-basis via online communication and is always available during working hours.

Locations

Country	Name	City	State
Netherlands	MST	Enschede

Sponsors (2)

Lead Sponsor	Collaborator
Philips Electronics Nederland B.V. acting through Philips CTO organization	Medisch Spectrum Twente

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	healthcare utilization	Difference in utilization of healthcare	during study period after 6 months
Secondary	assesment of effect of ehealth on asthma outcomes	asthma outcome measures	during study period (3 and 6 months)
Secondary	assess the effect of personalized real-time monitoring and education of inhalation	monitoring and education of inhalation	during study period (3 and 6 months)
Secondary	To investigate the effect of supervised nebulizer therapy	supervised nebulizer therapy	during study period (3 and 6 months)
Secondary	To correlate unobtrusive monitoring parameters and explore the feasibility and acceptance	unobtrusive monitoring parameters	during study period (3 and 6 months)
Secondary	To assess the perception of dyspnea in children	perception of dyspnea	during study period (3 and 6 months)
Secondary	To analyze the preluding period before an asthma exacerbation	preluding period	during study period (3 and 6 months)
Secondary	To identify the patient characteristics of children with successful eHealth care outcomes	patient characteristics	during study period (3 and 6 months)