Desktop Versus Mobile Data Collection in Clinical Trial

August 22, 2013 updated by: University of Zurich

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • St. Gallen, Switzerland, CH-9000
        • University of St. Gallen, Institute of Information Managemen
      • Zurich, Switzerland, CH-8091
        • University Hospital Zurich, Department of Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation score
Time Frame: 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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: 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
2 years
Cost-effectiveness analysis
Time Frame: 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).
2 years
Cost-benefit analysis
Time Frame: 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".
2 years
Cost-utility analysis
Time Frame: 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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

November 14, 2011

First Submitted That Met QC Criteria

November 16, 2011

First Posted (Estimate)

November 17, 2011

Study Record Updates

Last Update Posted (Estimate)

August 23, 2013

Last Update Submitted That Met QC Criteria

August 22, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PSP_Appendix_2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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