Trials / Withdrawn
WithdrawnNCT05517096
AmbuLatory Pediatric Asthma CAre
ALPACA : the Effect of Online Monitoring and Communication on the Quality and Quantity of Pediatric Asthma Care
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Philips Electronics Nederland B.V. acting through Philips CTO organization · Industry
- Sex
- All
- Age
- 4 Years – 11 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-10-07
- Primary completion
- 2023-09-15
- Completion
- 2024-03-01
- First posted
- 2022-08-26
- Last updated
- 2024-11-06
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT05517096. Inclusion in this directory is not an endorsement.