User ExperienceNCT01473238
Desktop Versus Mobile Data Collection in Clinical Trial
A study testing Evaluation form in people with User Experience, run by University of Zurich at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- User Experience
- What is being tested?
- Evaluation form
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jan 2014to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Clinicians and health care professionals not part of this trial
- Lacking of basic information technology literacy
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University of St. Gallen, Institute of Information Managemen
Sankt Gallen, CH-9000
Tobias Mettler, PhD, +41712243800, tobias.mettler@me.com
Tobias Mettler, PhD
University Hospital Zurich, Department of Surgery
Zurich, CH-8091
Dimitri A Raptis, MD, MSc, +41798820542, dimitri.raptis@usz.ch
Rolf Graf, PhD, +41442553041, rolf.graf@usz.ch
About this study
Official title: 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.
Read the 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.
- Conditions
- User Experience
- Being tested
- Evaluation form
- Keywords
- Desktop computer, Mobile, iPad, Evaluation, User experience, Benefits, Cost analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation formOther
Also called User evaluation questionnaire, User experience 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
| Study group | Role | What they receive |
|---|---|---|
| Desktop PC | Active comparator | Conventional institutional Desktop Personal Computers will be used to collect data of patients via a password protected encrypted interface. Receives: 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. Receives: Other: Evaluation form |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (4)
Recruitment rate
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
Measured: 2 years
Cost-effectiveness analysis
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).
Measured: 2 years
Cost-benefit analysis
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".
Measured: 2 years
Cost-utility analysis
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startJan 2014
- Primary completionJun 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for User ExperienceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dimitri A Raptis, MD, MSc, Principal investigator, University Hospital Zurich, Department of SurgeryRolf Graf, PhD, Principal investigator, University Hospital Zurich, Department of Surgical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473238
- Sponsor's protocol ID
- PSP_Appendix_2
- Status last verified
- Aug 2013
- First submitted
- 14 Nov 2011
- Last updated
- 23 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22010822Raptis 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.
PubMed 19713394Mirani R, Lederer A. An Instrument for Assessing the Organizational Benefits of IS projects. Decision Sciences, Vol. 29, No. 4, 1998, 803-838.
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Desktop vs. Mobile Data Collection in a Prospective Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT01473238
- Acronym / sponsor ID
- PSP_Appendix_2
- Conditions
- User Experience
- Keywords
- Desktop computer, Mobile, iPad, Evaluation, User experience, Benefits, Cost analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 17 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desktop PC | Active comparator | Other: Evaluation formConventional institutional Desktop Personal Computers will be used to collect data of patients via a password protected encrypted interface. |
| Mobile | Experimental | Other: Evaluation formNovel Mobile Clinical Trial Management System on iPads will be used to collect data of patients via a password protected encrypted interface. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Emergency Room doctors
- Surgeons
- Agree to participate in the trial
- Provide informed consent
- Have basic information technology literacy
Key exclusion criteria (2 listed)
- Clinicians and health care professionals not part of this trial
- Lacking of basic information technology literacy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation formAlso: User evaluation questionnaire, User experience formA 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 | Desktop PC, Mobile |
Primary outcome
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
4 secondary outcomes
Recruitment rate
Time frame: 2 years
Cost-effectiveness analysis
Time frame: 2 years
Cost-benefit analysis
Time frame: 2 years
Cost-utility analysis
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2013.
- Background: PubMed 22010822Raptis 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.
- Background: PubMed 19713394Raptis 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.
- BackgroundMirani R, Lederer A. An Instrument for Assessing the Organizational Benefits of IS projects. Decision Sciences, Vol. 29, No. 4, 1998, 803-838.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitri A Raptis, MD, MSc principal investigator
University Hospital Zurich, Department of Surgery
Rolf Graf, PhD principal investigator
University Hospital Zurich, Department of Surgical Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation form in people with User Experience, run by University of Zurich at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dimitri A Raptis, MD, MSc (+41798820542, dimitri.raptis@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation score (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01473238, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2013.