NCT04178122

Million Veteran Program Return of Actionable Results

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Detailed 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)

Conditions

• Cardiovascular Disease

Interventions

Type	Name	Description
GENETIC	Result disclosure	Disclosure of clinically confirmed, medically actionable genetic testing results and post-test genetic counseling session.

Timeline

• Start date: 2020-02-27
• Primary completion: 2024-09-08
• Completion: 2024-09-08
• First posted: 2019-11-26
• Last updated: 2025-10-16
• Results posted: 2025-10-16

Locations

1 site across 1 country: United States