An App to Identify Radiation Pneumonitis - a Pre-Study in Healthy Volunteers

ConditionLung Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Schleswig-Holstein

About this trial

Radiation pneumonitis is a possible side effect of radiotherapy for lung cancer. Since it often occurs only several weeks following radiotherapy, the corresponding symptoms may not be associated with previous administered radiotherapy. As a consequence, pneumonitis may be diagnosed very late or even be missed. Based on the findings of two prospective trials, a mobile application (PneumoCheck) has been developed, which can be used by the patients at home. This app may contribute to an earlier detection of radiation pneumonitis. Before this app can be tested in patients, its usability needs to be evaluated by healthy volunteers. In the present prospective study, 30 healthy volunteers test and rate the usability of the app. The healthy volunteers have to download the PneumoCheck app, which has been designed by the Luebeck based company Nextlabel Offene Handelsgesellschaft (OHG). After receiving the link for the download of the app from Nextlabel OHG by e-mail, the participants are asked to test the app and complete a questionnaire. They are asked to affirm or negate ten statements in three sections (download and installation, navigation, and content/functions) regarding the usability of the app. The satisfaction rate represents the rate of participants who affirmed a statement. If this rate was \<60%, the app was rated as not being useful. If the rate was between ≥60% but \<80%, the app was regarded useful but required further optimization regarding the corresponding section. In addition, iPhone and Android users are compared with respect to the satisfaction rates (Fisher's exact tests).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Possession of and ability to use a smart phone

Age ≥18 years

Written informed consent

Capacity of the participant to consent

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • PneumoCheck app

    Device

    The healthy volunteers have to download the PneumoCheck app, which has been designed by the Lübeck based company Nextlabel OHG. After receiving the link for the download of the app from Nextlabel OHG by e-mail, the participants are asked to test the app and complete a questionnaire. They are asked to affirm or negate ten statements in three sections (download and installation, navigation, and content/functions) regarding the usability of the app.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Healthy volunteers evaluating an appExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Satisfaction with the PneumoCheck app

The participants are asked to affirm or negate ten statements in three sections (download and installation, navigation, and content/functions) regarding the usability of the PneumoCheck app. The satisfaction rate represents the rate of participants who affirmed a statement. If this rate was \<60%, the reminder app was rated as not being useful. If the rate was between ≥60% but \<80%, the app was regarded useful but required further optimization regarding the corresponding section.

Time frame
1 day

Secondary outcomes

Other outcomes

Sponsors and contacts

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