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Desktop Versus Mobile Data Collection in Clinical Trial

This study is not yet open for participant recruitment.
Verified May 2012 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01473238
First received: November 14, 2011
Last updated: May 25, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention
User Experience
 Other: Evaluation form

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Desktop vs. Mobile Data Collection in a Prospective Multicenter Clinical Trial

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: August 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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

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.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473238

Contacts
Contact: Dimitri A Raptis, MD, MSc +41798820542 dimitri.raptis@usz.ch
Contact: Graf Rolf, PhD +41442553041 rolf.graf@usz.ch

Locations
Switzerland
University of St. Gallen, Institute of Information Managemen Not yet recruiting
St. Gallen, Switzerland, CH-9000
Contact: Tobias Mettler, PhD     +41712243800     tobias.mettler@me.com    
Principal Investigator: Tobias Mettler, PhD            
University Hospital Zurich, Department of Surgery Not yet recruiting
Zurich, Switzerland, CH-8091
Contact: Dimitri A Raptis, MD, MSc     +41798820542     dimitri.raptis@usz.ch    
Contact: Rolf Graf, PhD     +41442553041     rolf.graf@usz.ch    
Principal Investigator: Dimitri A Raptis, MD, MSc            
Sub-Investigator: Christoph Tschuor, MD            
Sub-Investigator: Christian E Oberlkofler, MD            
Principal Investigator: Rolf Graf, PhD            
Sponsors and Collaborators
University of Zurich
Investigators
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
  More Information

Additional Information:
The official online, web-based, password-protected, and encrypted clinical trial management system to support this multicenter clinical trial data collection and trial management  This link exits the ClinicalTrials.gov site
An Instrument for Assessing the Organizational Benefits of IS Projects  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01473238     History of Changes
Other Study ID Numbers: PSP_Appendix_2
Study First Received: November 14, 2011
Last Updated: May 25, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Zurich:
Desktop computer
Mobile
iPad
Evaluation
 User experience
Benefits
Cost analysis

ClinicalTrials.gov processed this record on June 18, 2013