Desktop Versus Mobile Data Collection in Clinical Trial

NCT ID: NCT01473238

Last Updated: 2013-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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User Experience

Keywords

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Desktop computer Mobile iPad Evaluation User experience Benefits Cost analysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Desktop PC

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

Group Type ACTIVE_COMPARATOR

Evaluation form

Intervention Type OTHER

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

Mobile

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

Group Type EXPERIMENTAL

Evaluation form

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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User evaluation questionnaire User experience form

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dimitri A Raptis, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Department of Surgery

Rolf Graf, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Department of Surgical Research

Locations

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University of St. Gallen, Institute of Information Managemen

Sankt Gallen, , Switzerland

Site Status

University Hospital Zurich, Department of Surgery

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Central Contacts

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Dimitri A Raptis, MD, MSc

Role: CONTACT

Phone: +41798820542

Email: [email protected]

Graf Rolf, PhD

Role: CONTACT

Phone: +41442553041

Email: [email protected]

Facility Contacts

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Tobias Mettler, PhD

Role: primary

Dimitri A Raptis, MD, MSc

Role: primary

Rolf Graf, PhD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 22010822 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19713394 (View on PubMed)

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

Reference Type BACKGROUND

Related Links

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http://onlinelibrary.wiley.com/doi/10.1111/j.1540-5915.1998.tb00878.x/abstract

An Instrument for Assessing the Organizational Benefits of IS Projects

Other Identifiers

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PSP_Appendix_2

Identifier Type: -

Identifier Source: org_study_id