Asthma in ChildrenNCT05517096
AmbuLatory Pediatric Asthma CAre
A study testing E-Health in people with Asthma in Children, run by Philips Clinical & Medical Affairs Global at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 4 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma in Children
- What is being tested?
- E-Health
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Oct 2022to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with moderate-to-severe asthma.
- Children in the age group from 4 up to and included 11 years old.
Who cannot join
- 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).
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma in Children
- Being tested
- E-Health
- Keywords
- E-health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-HealthOther
In the intervention phase asthma care is provided on an at-needed-basis via online communication and is always available during working hours.
| Study group | Role | What they receive |
|---|---|---|
| E-Health and monitoring | Experimental | eHealth care and explorative observational home-monitoring Receives: Other: E-Health |
| regular care and monitoring | No intervention | only explorative observational home-monitoring during regular care |
What is being measured
The primary outcome is the main question the study is designed to answer.
healthcare utilization
Difference in utilization of healthcare
Measured: during study period after 6 months
Secondary outcomes (7)
assesment of effect of ehealth on asthma outcomes
asthma outcome measures
Measured: during study period (3 and 6 months)
assess the effect of personalized real-time monitoring and education of inhalation
monitoring and education of inhalation
Measured: during study period (3 and 6 months)
To investigate the effect of supervised nebulizer therapy
supervised nebulizer therapy
Measured: during study period (3 and 6 months)
To correlate unobtrusive monitoring parameters and explore the feasibility and acceptance
unobtrusive monitoring parameters
Measured: during study period (3 and 6 months)
To assess the perception of dyspnea in children
perception of dyspnea
Measured: during study period (3 and 6 months)
To analyze the preluding period before an asthma exacerbation
preluding period
Measured: during study period (3 and 6 months)
To identify the patient characteristics of children with successful eHealth care outcomes
patient characteristics
Measured: during study period (3 and 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start7 Oct 2022
- Primary completion15 Sep 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Why it stopped: refocus of business
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medisch Spectrum Twente
- Responsible party
- Sponsor
- Investigators
- B.J. Thio, Pediatrician, Principal investigator, Medisch Spectrum Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517096
- Sponsor's protocol ID
- ICBE-S-000177
- Status last verified
- Nov 2024
- First submitted
- 18 Aug 2022
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37399066
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALPACA : the Effect of Online Monitoring and Communication on the Quality and Quantity of Pediatric Asthma Care
- ClinicalTrials.gov ID
- NCT05517096
- Acronym / sponsor ID
- ICBE-S-000177
- Conditions
- Asthma in Children
- Keywords
- E-health
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: refocus of business
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Collaborators
- Medisch Spectrum Twente
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 15 Sep 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| E-Health and monitoring | Experimental | Other: E-HealtheHealth care and explorative observational home-monitoring |
| regular care and monitoring | No intervention | –only explorative observational home-monitoring during regular care |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with moderate-to-severe asthma.
- Children in the age group from 4 up to and included 11 years old.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-HealthIn the intervention phase asthma care is provided on an at-needed-basis via online communication and is always available during working hours. | Other | E-Health and monitoring |
Primary outcome
healthcare utilization
Time frame: during study period after 6 months
Difference in utilization of healthcare
7 secondary outcomes
assesment of effect of ehealth on asthma outcomes
Time frame: during study period (3 and 6 months)
assess the effect of personalized real-time monitoring and education of inhalation
Time frame: during study period (3 and 6 months)
To investigate the effect of supervised nebulizer therapy
Time frame: during study period (3 and 6 months)
To correlate unobtrusive monitoring parameters and explore the feasibility and acceptance
Time frame: during study period (3 and 6 months)
To assess the perception of dyspnea in children
Time frame: during study period (3 and 6 months)
To analyze the preluding period before an asthma exacerbation
Time frame: during study period (3 and 6 months)
To identify the patient characteristics of children with successful eHealth care outcomes
Time frame: during study period (3 and 6 months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Derived from this study: PubMed 37399066van 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.
- Individual participant dataSharing planned: No
Related trials for Asthma in Children
Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Lung Diseases
Recruiting
Effects of Tele-rehabilitation-Guided Qigong on Children and Adolescents With Asthma
Asthma Childhood
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
RecruitingObservational study
Remote Monitoring of Asthma in Children and Young People
Asthma Childhood, Asthma Attack
Active, not recruiting
Community Health Equity Accelerator (CHEA) Pediatric Asthma Intervention
Asthma in Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
B.J. Thio, Pediatrician principal investigator
Medisch Spectrum Twente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-Health in people with Asthma in Children, run by Philips Clinical & Medical Affairs Global at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
healthcare utilization (time frame: during study period after 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05517096, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.