CClinicalTrials.gg
Status unknownNCT01473238Updated Aug 23, 2013

Desktop Versus Mobile Data Collection in Clinical Trial

An interventional study of Evaluation form in User Experience, sponsored by University of Zurich. Status unknown at 2 sites in Switzerland. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-08-23.

Sponsored by University of Zurich · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Aug 2013), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • User Experience

Keywords

  • Desktop computer
  • Mobile
  • iPad
  • Evaluation
  • User experience
  • Benefits
  • Cost analysis
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In context

Lead sponsor

University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Clinicians and health care professionals not part of this trial
  • Lacking of basic information technology literacy
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    Desktop PC

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

    Other: Evaluation form

  • Experimental
    Mobile

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

    Other: Evaluation form

Interventions

  • OtherEvaluation form

    A validated user experience evaluation questionnaire will be completed by each participant in the beginning, at the interim period, and at the end of the trial

    Also known as: User evaluation questionnaire, User experience form

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What researchers measure

Primary outcomes

  1. Evaluation score

    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

    Time frame: 2 years

Secondary outcomes

  1. Recruitment rate

    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

    Time frame: 2 years

  2. Cost-effectiveness analysis

    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).

    Time frame: 2 years

  3. Cost-benefit analysis

    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".

    Time frame: 2 years

  4. Cost-utility analysis

    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.

    Time frame: 2 years

07

Study locations

2 sites
  • University of St. Gallen, Institute of Information Managemen
    St. Gallen, CH-9000, Switzerland
    • Tobias Mettler, PhD · Contact · tobias.mettler@me.com · +41712243800
    • Tobias Mettler, PhD · Principal investigator
  • University Hospital Zurich, Department of Surgery
    Zurich, CH-8091, Switzerland
    • Dimitri A Raptis, MD, MSc · Contact · dimitri.raptis@usz.ch · +41798820542
    • Rolf Graf, PhD · Contact · rolf.graf@usz.ch · +41442553041
    • Dimitri A Raptis, MD, MSc · Principal investigator
    • Christoph Tschuor, MD · Sub investigator
    • Christian E Oberlkofler, MD · Sub investigator
    • Rolf Graf, PhD · Principal investigator
08

References and documents

Publications

  • Raptis DA, Mettler T, Tzanas K, Graf R. A novel open-source web-based platform promoting collaboration of healthcare professionals and biostatisticians: a design science approach. Inform Health Soc Care. 2012 Jan;37(1):22-36. doi: 10.3109/17538157.2011.590257. Epub 2011 Oct 19. PubMed 22010822 ↗
  • Raptis DA, Fernandes C, Chua W, Boulos PB. Electronic software significantly improves quality of handover in a London teaching hospital. Health Informatics J. 2009 Sep;15(3):191-8. doi: 10.1177/1460458209337431. PubMed 19713394 ↗
  • Mirani R, Lederer A. An Instrument for Assessing the Organizational Benefits of IS projects. Decision Sciences, Vol. 29, No. 4, 1998, 803-838.
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01473238
Lead sponsor
University of Zurich
Responsible party
Sponsor
First posted
Nov 17, 2011
Start date
Jan 2014
Primary completion
Jun 2014 (estimated)
Completion
Aug 2014 (estimated)
Last update
Aug 23, 2013

Study contacts

Dimitri A Raptis, MD, MSc
Contact
dimitri.raptis@usz.ch
+41798820542
Graf Rolf, PhD
Contact
rolf.graf@usz.ch
+41442553041
Dimitri A Raptis, MD, MSc
principal investigator · University Hospital Zurich, Department of Surgery
Rolf Graf, PhD
principal investigator · University Hospital Zurich, Department of Surgical Research

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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