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Clinical trial

Million Veteran Program Return of Actionable Results

ID
Name
MVP030
Description
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.
Trial arms
Trial start
2019-12-30
Estimated PCD
2024-09-30
Trial end
2024-09-30
Treatment
Result disclosure
Disclosure of clinically confirmed, medically actionable genetic testing results and post-test genetic counseling session.
Arms:
Delayed Results, Immediate Results
Size
254
Primary endpoint
LDL-C change
6 months
Eligibility criteria
Inclusion Criteria: * Living enrollee in MVP * Is identified to have a pathogenic or likely pathogenic variant in the gene(s) of interest in MVP genotype data Exclusion Criteria: * Previously underwent genetic testing for the condition of interest * Is incarcerated * Is pregnant
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 254, 'type': 'ESTIMATED'}}
Updated at
2023-10-05

1 organization

1 product

1 indication

Organization
VA Office of Research and Development
Product
Result disclosure
Indication
Cardiovascular Disease