Million Veteran Program Return of Actionable Results

Cardiovascular Disease Clinical Trial

— MVP-ROAR  

Official title:

Million Veteran Program Return of Actionable Results

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04178122
• Other study ID #: MVP030
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 30, 2019
• Est. completion date: September 30, 2024

Study information

• Verified date: October 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 254
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Genetic:
• Result disclosure
Disclosure of clinically confirmed, medically actionable genetic testing results and post-test genetic counseling session.

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Medication adherence	Medication adherence at 6 months, measured by the Beliefs About Medicines Questionnaire (BMQ). Statements are scored on a scale from 1 to 5, with higher scores indicating stronger beliefs in the concept.	6 months
Other	Cascade testing	The number of first-degree relatives having undergone genetic testing at 6 months.	6 months
Other	Lifestyle behaviors	Proportion of participants reporting healthy lifestyle behaviors (smoking, physical activity, and saturated fat intake) at 6 months, measured by questionnaire responses.	6 months
Other	Healthcare costs	Healthcare costs at 6 months, determined by budget impact analysis using administrative data.	6 months
Other	Quality of life (Veterans RAND Survey)	Quality of life, measured by the Veterans RAND (distributed by RAND Corporation) 12-item Health Survey (VR-12). Items are scored using an algorithm and summarized into two scores, a Physical Component Score and a Mental Component Score. Outcomes are compared to standardized scores and may be reported as z-scores.	6 months
Primary	LDL-C change	Change in LDL-C after 6 months.	6 months
Secondary	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.	6 months
Secondary	Pharmacotherapy	The proportion of participants with an intensification of lipid-lowering pharmacotherapy, a composite outcome including prescription of new monotherapy, dose escalation of existing pharmacotherapy, and addition of one or more medications to existing pharmacotherapy.	6 months