Electronic IIEF Validation

June 7, 2018 updated by: Prof.dr. J.J.M.C.H. de la Rosette, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Electronic Validation of the International Index of Erectile Function Questionnaire (IIEF) 5 and 15.

Questionnaires are used within urology to objectify disease burden and symptom changes during therapy. Recent technological improvements, as the smartphone and tablet, create new fill-out possibilities. However, questionnaires are only validated on paper. In order to use questionnaires for multiple platforms, electronic validation is needed. The International Prostate Symptom Score has already been validated on the smartphone. The International Index of Erectile Function (normal version of 15 questions and short version of 5 questions) is widely used within urology, however electronic validation is required for usage on electronic platforms in the future.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

173

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

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
        • AMC University Hospital

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Participants will be included at the outpatient clinic of the urology department at the Academic Medical Center in Amsterdam.

Description

Inclusion criteria:

  • Male patients, ≥40 years of age, presenting at the outpatient clinic of Urology of the Academic Medical Center in Amsterdam.
  • In possession of a smartphone, tablet or laptop/computer with internet connection.
  • Access to email.
  • Fluent speaking and reading the Dutch language.

Exclusion criteria:

  • Change in treatment, especially erectile dysfunction at consultation which could impact the short term IIEF outcome during the cross-over time.
  • Unable to provide informed consent.
  • Unfit according to the medical doctor (for example cognitive problems, leading to inadequate follow-up of instructions).

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IIEF5 paper-electronic
Other: Questionnaire - IIEF 5/15
International Index of Erectile Function
IIEF5 electronic-paper
Other: Questionnaire - IIEF 5/15
International Index of Erectile Function
IIEF15 paper-electronic
Other: Questionnaire - IIEF 5/15
International Index of Erectile Function
IIEF15 electronic-paper
Other: Questionnaire - IIEF 5/15
International Index of Erectile Function
IIEF5 electronic-electronic
Other: Questionnaire - IIEF 5/15
International Index of Erectile Function
IIEF15 electronic-electronic
Other: Questionnaire - IIEF 5/15
International Index of Erectile Function

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reliability
Time Frame: Per subject, thus 7 days.
The electronic IIEF-5 and 15 questionnaire is reliable when the ICC is ≥0.7, when compared with the paper version.
Per subject, thus 7 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preference for paper or electronic
Time Frame: Per subject, after 7 days.
The electronic version of the IIEF-5 and 15 is preferred when ≥70% of the subjects have no preference or prefer the electronic version over the paper version.
Per subject, after 7 days.

Collaborators and Investigators

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

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

Société Internationale d'Urologie

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 (Actual)

July 25, 2017

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

June 27, 2017

First Submitted That Met QC Criteria

July 17, 2017

First Posted (Actual)

July 19, 2017

Study Record Updates

Last Update Posted (Actual)

June 8, 2018

Last Update Submitted That Met QC Criteria

June 7, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17.281

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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