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AmbuLatory Pediatric Asthma CAre

Primary Purpose

Asthma in Children

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
E-Health
Sponsored by
Philips Electronics Nederland B.V. acting through Philips CTO organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma in Children focused on measuring E-health

Eligibility Criteria

4 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • MSTRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

E-Health and monitoring

regular care and monitoring

Arm Description

eHealth care and explorative observational home-monitoring

only explorative observational home-monitoring during regular care

Outcomes

Primary Outcome Measures

healthcare utilization
Difference in utilization of healthcare

Secondary Outcome Measures

assesment of effect of ehealth on asthma outcomes
asthma outcome measures
assess the effect of personalized real-time monitoring and education of inhalation
monitoring and education of inhalation
To investigate the effect of supervised nebulizer therapy
supervised nebulizer therapy
To correlate unobtrusive monitoring parameters and explore the feasibility and acceptance
unobtrusive monitoring parameters
To assess the perception of dyspnea in children
perception of dyspnea
To analyze the preluding period before an asthma exacerbation
preluding period
To identify the patient characteristics of children with successful eHealth care outcomes
patient characteristics

Full Information

First Posted
August 18, 2022
Last Updated
November 1, 2022
Sponsor
Philips Electronics Nederland B.V. acting through Philips CTO organization
Collaborators
Medisch Spectrum Twente
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1. Study Identification

Unique Protocol Identification Number
NCT05517096
Brief Title
AmbuLatory Pediatric Asthma CAre
Official Title
ALPACA : The Effect of Online Monitoring and Communication on the Quality and Quantity of Pediatric Asthma Care
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2022 (Actual)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Electronics Nederland B.V. acting through Philips CTO organization
Collaborators
Medisch Spectrum Twente

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children
Keywords
E-health

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
E-Health and monitoring
Arm Type
Experimental
Arm Description
eHealth care and explorative observational home-monitoring
Arm Title
regular care and monitoring
Arm Type
No Intervention
Arm Description
only explorative observational home-monitoring during regular care
Intervention Type
Other
Intervention Name(s)
E-Health
Intervention Description
In the intervention phase asthma care is provided on an at-needed-basis via online communication and is always available during working hours.
Primary Outcome Measure Information:
Title
healthcare utilization
Description
Difference in utilization of healthcare
Time Frame
during study period after 6 months
Secondary Outcome Measure Information:
Title
assesment of effect of ehealth on asthma outcomes
Description
asthma outcome measures
Time Frame
during study period (3 and 6 months)
Title
assess the effect of personalized real-time monitoring and education of inhalation
Description
monitoring and education of inhalation
Time Frame
during study period (3 and 6 months)
Title
To investigate the effect of supervised nebulizer therapy
Description
supervised nebulizer therapy
Time Frame
during study period (3 and 6 months)
Title
To correlate unobtrusive monitoring parameters and explore the feasibility and acceptance
Description
unobtrusive monitoring parameters
Time Frame
during study period (3 and 6 months)
Title
To assess the perception of dyspnea in children
Description
perception of dyspnea
Time Frame
during study period (3 and 6 months)
Title
To analyze the preluding period before an asthma exacerbation
Description
preluding period
Time Frame
during study period (3 and 6 months)
Title
To identify the patient characteristics of children with successful eHealth care outcomes
Description
patient characteristics
Time Frame
during study period (3 and 6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
I Geven, master Science
Phone
+31646545735
Email
inge.geven@philips.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
B.J. Thio, Pediatrician
Organizational Affiliation
Medisch Spectrum Twente
Official's Role
Principal Investigator
Facility Information:
Facility Name
MST
City
Enschede
ZIP/Postal Code
7500KA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
B.J. Thio, PhD
Email
b.thio@mst.nl

12. IPD Sharing Statement

Plan to Share IPD
No

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AmbuLatory Pediatric Asthma CAre

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