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refocus of business
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| Name | Class |
|---|---|
| Medisch Spectrum Twente | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E-Health and monitoring | Experimental | eHealth care and explorative observational home-monitoring |
|
| regular care and monitoring | No Intervention | only explorative observational home-monitoring during regular care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| healthcare utilization | Difference in utilization of healthcare | during study period after 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| B.J. Thio, Pediatrician | Medisch Spectrum Twente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MST | Enschede | 7500KA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37399066 | Derived | 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. |
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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.
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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) |