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Million Veteran Program Return of Actionable Results (MVP-ROAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04178122
Recruitment Status : Enrolling by invitation
First Posted : November 26, 2019
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Genetic: Result disclosure Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Million Veteran Program Return of Actionable Results
Actual Study Start Date : December 30, 2019
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2022

Arm Intervention/treatment
Experimental: Immediate Results
Participants in the Immediate Results arm will receive their genetic testing results from a genetic counselor at baseline following randomization.
Genetic: Result disclosure
Disclosure of clinically confirmed, medically actionable genetic testing results and post-test genetic counseling session.

Experimental: Delayed Results
Participants in the Delayed Results arm will receive their genetic testing results from a genetic counselor 6 months after randomization.
Genetic: Result disclosure
Disclosure of clinically confirmed, medically actionable genetic testing results and post-test genetic counseling session.




Primary Outcome Measures :
  1. LDL-C change [ Time Frame: 6 months ]
    Change in LDL-C after 6 months.


Secondary Outcome Measures :
  1. LDL-C target [ Time Frame: 6 months ]
    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.

  2. Pharmacotherapy [ Time Frame: 6 months ]
    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.


Other Outcome Measures:
  1. Medication adherence [ Time Frame: 6 months ]
    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.

  2. Cascade testing [ Time Frame: 6 months ]
    The number of first-degree relatives having undergone genetic testing at 6 months.

  3. Lifestyle behaviors [ Time Frame: 6 months ]
    Proportion of participants reporting healthy lifestyle behaviors (smoking, physical activity, and saturated fat intake) at 6 months, measured by questionnaire responses.

  4. Healthcare costs [ Time Frame: 6 months ]
    Healthcare costs at 6 months, determined by budget impact analysis using administrative data.

  5. Quality of life (Veterans RAND Survey) [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04178122


Locations
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United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Study Chair: Jason L Vassy, MD MPH VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04178122    
Other Study ID Numbers: MVP030
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share de-identified individual-level trial data through a data repository housed on a secure VA server and accessible only to outside investigators with IRB and other regulatory approvals. MVP ROAR Study data will also be stored in the VA MVP Central Database.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cardiovascular Diseases