NCT01473238

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2011

Completed
2.1 years until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

August 23, 2013

Status Verified

August 1, 2013

Enrollment Period

5 months

First QC Date

November 14, 2011

Last Update Submit

August 22, 2013

Conditions

User Experience

Keywords

Desktop computerMobileiPadEvaluationUser experienceBenefitsCost analysis

Outcome Measures

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

    2 years

Secondary Outcomes (4)

  • Recruitment rate

    2 years

  • Cost-effectiveness analysis

    2 years

  • Cost-benefit analysis

    2 years

  • Cost-utility analysis

    2 years

Study Arms (2)

Desktop PC

ACTIVE COMPARATOR

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

Other: Evaluation form

Mobile

EXPERIMENTAL

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

Evaluation formOTHER

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
Desktop PCMobile

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of St. Gallen, Institute of Information Managemen

Sankt Gallen, CH-9000, Switzerland

Location

University Hospital Zurich, Department of Surgery

Zurich, CH-8091, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 22010822BACKGROUND

  • 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.

    PMID: 19713394BACKGROUND

  • Mirani R, Lederer A. An Instrument for Assessing the Organizational Benefits of IS projects. Decision Sciences, Vol. 29, No. 4, 1998, 803-838.

    BACKGROUND

Related Links

Study Officials

  • Dimitri A Raptis, MD, MSc

    University Hospital Zurich, Department of Surgery

    PRINCIPAL INVESTIGATOR

  • Rolf Graf, PhD

    University Hospital Zurich, Department of Surgical Research

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dimitri A Raptis, MD, MSc

CONTACT

+41798820542dimitri.raptis@usz.ch

Graf Rolf, PhD

CONTACT

+41442553041rolf.graf@usz.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2011

First Posted

November 17, 2011

Study Start

January 1, 2014

Primary Completion

June 1, 2014

Study Completion

August 1, 2014

Last Updated

August 23, 2013

Record last verified: 2013-08

Locations

CH(2)