Clinical trial NCT01334476: VISN 19 MIRECC Research Database
Official title: VISN 19 MIRECC Research Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Demographic Data
History of Medical and Mental Health
History of Combat Experience
History of Suicide
Imaging Results
Keywords: Data Repository
Facilitate Recruitment of Participants for Ongoing and Future Research
Lead sponsor: VA Eastern Colorado Health Care System
Sponsor class: FED
First posted: 2011-04-13
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Receiving Medical Treatment at the Denver VA Medical Center 18 or older

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Permission to contact for future studies
timeFrame: One time
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: VA Eastern Colorado Health Care System
state: Colorado
city: Denver
country: United States
facility: VHAECH Denver VA Medical Center
state: Colorado
Study officials:
affiliation: VA ECHCS
name: Lisa Brenner, PhD
role: PRINCIPAL_INVESTIGATOR
References: