Desktop Versus Mobile Data Collection in Clinical Trial

University of Zurich (UZH)

Status: Unknown

Conditions: User Experience

Treatments: Other: Evaluation form

Study type: Interventional

Funder types: Other

Identifiers

NCT01473238

PSP_Appendix_2

Details and patient eligibility

About

Paper-based data collection for prospective clinical trials is associated with a poor quality of data collection. This typically involves missing or wrong data entry or a low recruitment rate, mainly due to the cumbersome and uncontrolled data collection.

Electronic data collection is associated with improved quality of data entry in the cases of Electronic Patient Records (EPR) and patient handover among doctors during night and day shifts. However, a comprehensive direct comparison between web-based desktop personal computer (PC) and mobile (e.g. iPad) data collection has not yet been reported.

The purpose of this prospective trial is to compare the users' experience with the web-based desktop PC and mobile data collection (iPad) tools.

Full description

The investigators designed a prospective randomized controlled trial where doctors from several randomly selected hospitals will use either a desktop PC or mobile (iPad) data collection tool. A validated user experience evaluation instrument will be used at the beginning, during interim analysis and at the end of the trial.

The desktop-based data collection is built on Drupal, a renowned open source content management system (CMS). The same CMS will be used with a special interface designed for iOS/iPad. Both data collection platforms will be used in parallel to a prospective clinical trial.

Enrollment: 20 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Emergency Room doctors
• Surgeons
• Agree to participate in the trial
• Provide informed consent
• Have basic information technology literacy
• Agree to receive brief training of the platform

Exclusion criteria

• Clinicians and health care professionals not part of this trial
• Lacking of basic information technology literacy

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Desktop PC

Active Comparator group

Description:

Conventional institutional Desktop Personal Computers will be used to collect data of patients via a password protected encrypted interface.

Treatment:

Other: Evaluation form

Mobile

Experimental group

Description:

Novel Mobile Clinical Trial Management System on iPads will be used to collect data of patients via a password protected encrypted interface.

Treatment:

Other: Evaluation form