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

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ClinicalTrials.gov Identifier: NCT00921466
Recruitment Status : Unknown
Verified June 2009 by Rogers Center for Research & Training, Inc..
Recruitment status was:  Enrolling by invitation
First Posted : June 16, 2009
Last Update Posted : June 16, 2009
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Rogers Center for Research & Training, Inc.

Brief Summary:
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.

Condition or disease
Healthy

Study Type : Observational
Actual Enrollment : 20 participants
Time Perspective: Prospective
Official Title: Pilot Study to Assess Feasibility, Reliability and Validity of the e-SSRS-IVR
Study Start Date : June 2009
Estimated Primary Completion Date : July 2009
Estimated Study Completion Date : August 2009

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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00921466


Locations
United States, Wisconsin
Rogers Center for Research and Training, Inc
Milwaukee, Wisconsin, United States, 53227
Sponsors and Collaborators
Rogers Center for Research & Training, Inc.
GlaxoSmithKline
Investigators
Principal Investigator: John H Greist, MD Rogers center for Research and Training, Inc

Additional Information:
Responsible Party: Dr John Greist, Rogers Center for Research and Training, Inc
ClinicalTrials.gov Identifier: NCT00921466     History of Changes
Other Study ID Numbers: 113235
First Posted: June 16, 2009    Key Record Dates
Last Update Posted: June 16, 2009
Last Verified: June 2009

Keywords provided by Rogers Center for Research & Training, Inc.:
Evaluate the clinical content of the e-SSRS-IVR