Desktop Versus Mobile Data Collection in Clinical Trial

This study is not yet open for participant recruitment.
Verified August 2013 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01473238
First received: November 14, 2011
Last updated: August 22, 2013
Last verified: August 2013

November 14, 2011
August 22, 2013
January 2014
June 2014   (final data collection date for primary outcome measure)
Evaluation score [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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

Same as current
Complete list of historical versions of study NCT01473238 on ClinicalTrials.gov Archive Site
  • Recruitment rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Desktop Versus Mobile Data Collection in Clinical Trial
Desktop vs. Mobile Data Collection in a Prospective Multicenter Clinical Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
User Experience
Other: Evaluation 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
Other Names:
  • User evaluation questionnaire
  • User experience form
  • Active Comparator: Desktop PC
    Conventional institutional Desktop Personal Computers will be used to collect data of patients via a password protected encrypted interface.
    Intervention: 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.
    Intervention: Other: Evaluation form

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
August 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
25 Years to 65 Years
Yes
Contact: Dimitri A Raptis, MD, MSc +41798820542 dimitri.raptis@usz.ch
Contact: Graf Rolf, PhD +41442553041 rolf.graf@usz.ch
Switzerland
 
NCT01473238
PSP_Appendix_2
Yes
University of Zurich
University of Zurich
Not Provided
Principal Investigator: Dimitri A Raptis, MD, MSc University Hospital Zurich, Department of Surgery
Principal Investigator: Rolf Graf, PhD University Hospital Zurich, Department of Surgical Research
University of Zurich
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP