NCT00921466

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2009

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

June 16, 2009

Status Verified

June 1, 2009

Enrollment Period

1 month

First QC Date

June 15, 2009

Last Update Submit

June 15, 2009

Conditions

Healthy

Keywords

Evaluate the clinical content of the e-SSRS-IVR

Study Arms (2)

Hospital Patients/Hospital Employees

Hospital employees

A group of 10 hospital employees used as baseline

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rogers Center for Research and Training, Inc

Milwaukee, Wisconsin, 53227, United States

Location

Related Links

Study Officials

  • John H Greist, MD

    Rogers center for Research and Training, Inc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2009

First Posted

June 16, 2009

Study Start

June 1, 2009

Primary Completion

July 1, 2009

Study Completion

August 1, 2009

Last Updated

June 16, 2009

Record last verified: 2009-06

Locations

US(1)