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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Rogers Center for Research & Training, Inc..
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00921466
First Posted: June 16, 2009
Last Update Posted: June 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by:
Rogers Center for Research & Training, Inc.
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (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
  Contacts and Locations
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
  More Information

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 Submitted: June 15, 2009
First Posted: June 16, 2009
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