Ignite Creation Date:
2024-05-06 @ 1:59 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04178122
Status:
COMPLETED
Last Update Posted:
2023-10-05
First Post:
2019-11-20
Brief Title:
Million Veteran Program Return of Actionable Results
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Million Veteran Program Return of Actionable Results
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MVP-ROAR
Brief 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 100mgdL for primary prevention and 70 mgdL 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
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 100mgdL for primary prevention and 70 mgdL 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None