Pilot Study to Assess Feasibility, Reliability and Validity of the e-SSRS-IVR (e-SSRS-IVR)

June 15, 2009 updated by: Rogers Center for Research & Training, Inc.
The proposed study is designed to evaluate the clinical contents of the e-SSRS-IVR with respect to 1.the intent of the instrument (assess face and content validity), 2. system validation with respect to programming integrity, 3. implementation feasibility in clinical ill and healthy patient populations, and 4. criterion/predictive validity to discriminate patient population with known clinical status differences.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

20

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

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53227
        • Rogers Center for Research and Training, Inc

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Study subjects will be recruited from a single clinical site (Rogers Memorial Hospital, Milwaukee WI). Half of the subjects will be recruited through public advertisement for Rogers Hospital employees and the other half will be recruited from recent inpatient psychiatric admissions.

Description

Inclusion Criteria:

  • English speaking adults, able/willing to read and provide written consent

Exclusion Criteria:

  • Dementia, delirium, psychosis or deafness.
  • Control subjects will be excluded for any MINI lifetime MDD or dysthymia diagnosis of a DSM-IV disorder except for specific phobia or dependence on nicotine and caffeine.
  • Inpatients not admitted with suicidal ideations

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

Cohorts and Interventions

Group / Cohort
Hospital Patients/Hospital Employees
Hospital employees
A group of 10 hospital employees used as baseline

Collaborators and Investigators

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

Sponsor

Rogers Center for Research & Training, Inc.

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: John H Greist, MD, Rogers Center for Research and Training, Inc

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.

Helpful Links

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

June 1, 2009

Primary Completion (Anticipated)

July 1, 2009

Study Completion (Anticipated)

August 1, 2009

Study Registration Dates

First Submitted

June 15, 2009

First Submitted That Met QC Criteria

June 15, 2009

First Posted (Estimate)

June 16, 2009

Study Record Updates

Last Update Posted (Estimate)

June 16, 2009

Last Update Submitted That Met QC Criteria

June 15, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 113235

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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