AmbuLatory Pediatric Asthma CAre

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Asthma in Children
• Intervention / Treatment: Other: E-Health

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Enschede, Netherlands, 7500KA
    • MST

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 11 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E-Health and monitoring; eHealth care and explorative observational home-monitoring	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.
No Intervention: regular care and monitoring; only explorative observational home-monitoring during regular care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
healthcare utilization	Difference in utilization of healthcare	during study period after 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Philips Electronics Nederland B.V. acting through Philips CTO organization
• Collaborators: Medisch Spectrum Twente
• Investigators: Principal Investigator: B.J. Thio, Pediatrician, Medisch Spectrum Twente

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2022
• Primary Completion (Estimated): September 15, 2023
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: E-health
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: ICBE-S-000177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No