Million Veteran Program Return of Actionable Results

Last updated: September 30, 2025
Sponsor: VA Office of Research and Development
Overall Status: Completed

Phase

N/A

Condition

Vascular Diseases

Cardiac Disease

Diabetes Prevention

Treatment

Result disclosure

Clinical Study ID

NCT04178122
MVP030
  • Ages > 22
  • All Genders

Study Summary

The purpose of the Million Veteran Program- Return of Actionable Results (MVP-ROAR) Study is to develop a process to return medically actionable genetic results to living MVP participants nationwide and to determine the impact of doing so on medical management and outcomes and Veteran quality of life.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Living enrollee in MVP

  • Is identified to have a pathogenic or likely pathogenic variant in the gene(s) ofinterest in MVP genotype data

Exclusion

Exclusion Criteria:

  • Previously underwent genetic testing for the condition of interest

  • Is incarcerated

  • Is pregnant

Study Design

Total Participants: 112
Treatment Group(s): 1
Primary Treatment: Result disclosure
Phase:
Study Start date:
February 27, 2020
Estimated Completion Date:
September 08, 2024

Study Description

The Million Veteran Program - Return of Actionable Results (MVP-ROAR) Study is a randomized controlled trial of immediate vs. delayed (after 6 months) return of medically actionable, clinically confirmed genetic testing results. MVP participants with a medically actionable variant in their MVP chip genotype data will be contacted and offered the opportunity to receive clinical confirmation of this result through a research protocol. First, a non-randomized pilot trial will be conducted among 10 eligible MVP participants, followed by a randomized controlled trial of immediate vs. delayed clinical confirmation and reporting, delivered to participants nationwide via telegenetic counseling.

Three hypotheses will be tested:

Hypothesis 1 (LDL-C change): LDL-C reduction after 6 months will be greater in the Immediate Results arm compared to the Delayed Results arm (primary outcome) Hypothesis 2 (LDL-C target): The proportion of participants meeting clinically significant LDL-C targets (<100mg/dL for primary prevention and <70 mg/dL for secondary prevention) at 6 months will be greater in the Immediate Results arm than in the Delayed Results arm (secondary outcome) Hypothesis 3 (Pharmacotherapy): the proportion of participants with an intensification of lipid-lowering pharmacotherapy will be greater in the Immediate Results arm than in the Delayed Results arm (secondary outcome)

Connect with a study center

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    Boston, Massachusetts 02130-4817
    United States

    Site Not Available

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    Boston 4930956, Massachusetts 6254926 02130-4817
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.