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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Rogers Center for Research & Training, Inc.
ClinicalTrials.gov Identifier:
NCT00921466
First received: June 15, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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
Healthy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pilot Study to Assess Feasibility, Reliability and Validity of the e-SSRS-IVR

Further study details as provided by Rogers Center for Research & Training, Inc.:

Enrollment: 20
Study Start Date: June 2009
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hospital Patients/Hospital Employees
Hospital employees
A group of 10 hospital employees used as baseline

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Dr John Greist, Rogers Center for Research and Training, Inc
ClinicalTrials.gov Identifier: NCT00921466     History of Changes
Other Study ID Numbers: 113235
Study First Received: June 15, 2009
Last Updated: June 15, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 27, 2014