Desktop Versus Mobile Data Collection in Clinical Trial

Not Applicable

• Conditions: User Experience
• Interventions: Other: Evaluation form

• Registration Number: NCT01473238
• Lead Sponsor: University of Zurich

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2011-11-14
• Study First Submitted QC: 2011-11-16
• Study First Posted: 2011-11-17
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-22
• Last Update Posted: 2013-08-23
• Study Start: 2014-01
• Primary Completion: 2014-06
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Desktop PC	Evaluation form	Conventional institutional Desktop Personal Computers will be used to collect data of patients via a password protected encrypted interface.
Mobile	Evaluation form	Novel Mobile Clinical Trial Management System on iPads will be used to collect data of patients via a password protected encrypted interface.

Primary Outcome Measures

Name	Time	Method
Evaluation score	2 years	A validated user experience and evaluation instrument will be used.; The overall score will be compared between the Desktop PC and Mobile (iPad) data collection tools.; PC: indicates Personal Computer

Secondary Outcome Measures

Name	Time	Method
Recruitment rate	2 years	The recruitment rate is defined as the proportion of patients recruited divided by the total number of patients recruited + patients missed: (rate=recruited/(recruited+missed).; The recruitment rates will be compared between the Desktop PC and Mobile (iPad) data collection tools.; PC: indicates Personal Computer
Cost-effectiveness analysis	2 years	Cost-effectiveness analysis (CEA) is a form of economic analysis that compares the relative costs and outcomes (effects) of two or more courses of action. CEA assigns a monetary value to the measure of effect. Typically the CEA is expressed in terms of a ratio where the denominator is a gain from a measure and the numerator is the cost associated with this gain.; In this study, CEA will be calculated as: (ratio=costs/evaluation score) and (ratio=costs/recruitment rate).
Cost-benefit analysis	2 years	Cost-benefit analysis (CBA) is a systematic process for calculating and comparing benefits and costs of a project for two purposes; in order to determine if it is a sound investment (justification/feasibility), and to see how it compares with alternate projects (ranking/priority assignment). It involves comparing the total expected cost of each option against the total expected benefits, to see whether the benefits outweigh the costs, and by how much. In CBA, benefits and costs are expressed in money terms, and are adjusted for the "time value of money".
Cost-utility analysis	2 years	Cost-utility analysis (CUA) is a form of financial analysis used to guide procurement decisions. The most common and well-known application of this analysis is in health technology assessment. Cost is measured in monetary units.

Trial Locations

Locations (2)

University of St. Gallen, Institute of Information Managemen; 🇨🇭 St. Gallen, Switzerland

University Hospital Zurich, Department of Surgery; 🇨🇭 Zurich, Switzerland