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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01334476
Other study ID # 10-0554
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 2010
Est. completion date March 2026

Study information

Verified date December 2023
Source VA Eastern Colorado Health Care System
Contact Lisa Brenner, PhD
Phone (303) 399-8020
Email Lisa.Brenner@va.gov
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The VISN 19 MIRECC is involved in research concerned with suicide prevention in high risk populations (e.g., history of traumatic brain injury, post-traumatic stress disorder); Recruitment for future studies will continue with a similar focus. The aim of this protocol is for the VISN 19 MIRECC Research Database (V19-MRD), to have a data repository of participants for possible recruitment from other studies being conducted at the VISN 19 MIRECC. The VISN 19 MIRECC conducts numerous research projects under the review of COMIRB and the VA R&D.


Description:

This protocol seeks to formally create the database that will store demographic data. The data will be used by VISN 19 MIRECC Investigators solely for recruitment purposes for future studies. The repository data will include: 1. Data regarding individuals in existing study databases who have already provided permission to have their information stored and used for future recruitment into VISN 19 MIRECC research studies (specific data elements to be collected will be articulated below). 2. Data of individuals to be collected and saved to use for future recruitment into VISN 19 MIRECC research studies. A restricted section of the V19-MRD will contain V19-MRD identification numbers and identifying data including name (first, last, middle initial), Social Security number, phone number(s) (primary and secondary), date of birth, and mailing address. A less restricted section of the V19-MRD will contain V19-MRD identification numbers, the COMIRB protocol number of the study the participant was recruited from, gender, year of birth, and criteria identifiers marked as present or absent (i.e., history of medical and mental health conditions, history of suicide - thoughts/behaviors, history of combat experience, and presence of imaging results). The V19-MRD would enhance current research strategies by first allowing VISN 19 MIRECC Investigators an efficient method to conduct preliminary or ongoing investigations to determine if: 1) sufficient populations exist to conduct a study; or 2) potential participants meeting specific study criteria are included in the database who could be contacted regarding study participation. Second, with an approved protocol, the V19-MRD contact section of the database could be used to facilitate mailings to potential participants.


Recruitment information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date March 2026
Est. primary completion date March 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Being a Patient at the Denver VA Medical Center - 18 years or Older - Participated in another study at the VISN 19 MIRECC Exclusion Criteria: - Not a Patient at the Denver VA Medical Center - Younger than 18 years - Never Participated on a Study Within the VISN 19 MIRECC

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States VA Eastern Colorado Health Care System Denver Colorado
United States VHAECH Denver VA Medical Center Denver Colorado

Sponsors (1)

Lead Sponsor Collaborator
VA Eastern Colorado Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Permission to contact for future studies One time