AmbuLatory Pediatric Asthma CAre

NCT05517096 | Withdrawn

• 1 other identifier: ICBE-S-000177
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma in Children

Keywords

E-health

Outcome Measures

Primary Outcomes (1)

• healthcare utilization

  Difference in utilization of healthcare

  during study period after 6 months

Secondary Outcomes (7)

• assesment of effect of ehealth on asthma outcomes

  during study period (3 and 6 months)

• assess the effect of personalized real-time monitoring and education of inhalation

  during study period (3 and 6 months)

• To investigate the effect of supervised nebulizer therapy

  during study period (3 and 6 months)

• To correlate unobtrusive monitoring parameters and explore the feasibility and acceptance

  during study period (3 and 6 months)

• To assess the perception of dyspnea in children

  during study period (3 and 6 months)

Study Arms (2)

E-Health and monitoring

EXPERIMENTAL

eHealth care and explorative observational home-monitoring

Other: E-Health

regular care and monitoring

NO INTERVENTION

only explorative observational home-monitoring during regular care

Interventions

E-Health OTHER

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

E-Health and monitoring

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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).
• Having been positively tested as infected with COVID-19 in the past 14 days

Sponsors & Collaborators

• Philips Electronics Nederland B.V. acting through Philips CTO organization: lead
• Medisch Spectrum Twente: collaborator

Study Sites (1)

MST

Enschede, 7500KA, Netherlands

Location

Related Publications (1)

• van der Kamp M, Hengeveld V, Willard N, Thio B, de Graaf P, Geven I, Tabak M. Remote Patient Monitoring and Teleconsultation to Improve Health Outcomes and Reduce Health Care Utilization of Pediatric Asthma (ALPACA Study): Protocol for a Randomized Controlled Effectiveness Trial. JMIR Res Protoc. 2023 Jul 3;12:e45585. doi: 10.2196/45585.

  PMID: 37399066 DERIVED

Study Officials

• B.J. Thio, Pediatrician

  Medisch Spectrum Twente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In the first phase subjects are block randomized (section 7.2) to either eHealth care and explorative observational home-monitoring or only explorative observational home-monitoring during regular care. The second phase is a follow-up period of 3 months to evaluate the effects of eHealth care compared to the control group and how long these effects can last.

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 26, 2022
• Study Start: October 7, 2022
• Primary Completion: September 15, 2023
• Study Completion: March 1, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)