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"Monitoring inhalation technique"

“What is the effect of filming and reviewing using an iPad in asthma management in children aged 6-18 years?”

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21392
Enrollment
40
Registered
2014-05-01
Start date
2014-05-10
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma management

Interventions

The use of an iPad to film and review the inhalation technique.

Sponsors

Pediatric lung specialist (Dr BJ Thio) Medisch Spectrum Twente
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Clinical history of asthma symptoms Age 6-18 years Ability to record and send videoclips of inhalation technique with an iPad. Significant drop in FEV1 during an exercise challenge test (25-30%)

Exclusion criteria

Exclusion criteria: Inability to operate an iPad

Design outcomes

Primary

MeasureTime frame
The fall in FEV1 during an ECT, on a trampoline (6-12 year) or a treadmill (12-18 year), will be measured . The endpoint is the fall in FEV1at the ECT . The ECT performed on a treadmill is according to ATS/ERS recommendations. The ECT’s will be performed at the paediatric department. Children will run, nose clipped, on a treadmill with a 10% to 19, 5% slope, for 3 min period (7 times) with a heart rate at 80% of predicted maximum (210-age). The children less than 12 years perform the ECT on a trampoline. Children will be asked to jump 3 times 2 minutes on a trampoline with a heart rate at 80% of the predicted maximum (210-age).

Secondary

MeasureTime frame
• The use of Salbutamol in both groups, the children receive during visit 1 a Salbutamol inhaler for symptoms of breathlessness during the 4 weeks. This inhaler contains a counter that counts how many times the inhaler is used. • The scores in critical errors of inhalation technique after 4 weeks treatment. Inhalation technique will be scored according to standardized inhalation protocols designed by the Lung Alliance Netherlands (LAN) for every inhalation device (see appendix). • The symptom score endpoint will be the measured by the ACT; this is a questionnaire that is answered by caregivers(s) and the child. The first 4 questions must be answered by the child, the last three by the caregiver(s). Score below 20 points; the asthma is not likely to have been under control for the past 4 weeks. 20 points or more; the asthma was probably well under control over the last 4 weeks.

Contacts

Public ContactB.J. Thio

Postbus 50.000

B.Thio@ziekenhuis-mst.nl+31 (0)53 4872310

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)