Family at Risk Study

Summary

Atherosclerotic cardiovascular disease (ASCVD) risk factors include hypertension as a key risk factor, as well as hyperlipidemia, diabetes, smoking, obesity, diet, inactivity, family history and age. These are highly prevalent in the US population with risk factor control far from optimal.1-3 Hypertension affects approximately 30% of adults and the US Preventive Services Task Force (USPSTF) supports population screening.4 Many individuals have multiple risk factors, with declining rates of control with an increasing numbers of risk factors,5 but greater benefit through the control of multiple risk factors.6 Prior approaches to primary and primordial ASCVD risk mitigation generally fail to target motivated populations for identification and modification of risk factors. Data from the ongoing project C3FIT has shown first-degree relatives of a stroke patient are such a highly motivated population, having seen the end result of failed ASCVD risk control in their relative. Also, family history of stroke or heart disease is an independent risk factor for ASCVD including stroke and heart attack7-11 and there is a family risk-factor clustering putting this group at higher risk.12-14 However, current clinical practice does not seize the opportunity to assess and intervene on the family members of individuals with stroke or CAD despite their being enriched with individuals at elevated risk and high motivation to reduce that risk.

The Family at Risk (FAR) Trial targets this high-risk/high-motivation population of the biological offspring and siblings of an index stroke patient. FAR will evaluate two strategies for risk factor control: 1) FAR-Education/Coaching Arm (FAR-EC Arm): providing education from the American Heart/American Stroke Association (AHA/ASA) and coaching on risk factor control, versus 2) FAR-Enhanced Intervention Arm (FAR-EI Arm): the education and coaching strategy described above plus a combined virtual and in-person m-health management strategy to modify ASCVD risk factors using HealthStream/Harmonize technology. This supplemental management includes a home-based and family-focused participant-centric strategy for identification of ASCVD risk factors, education tailored to participant needs, and implementation of a technology-enabled m-health management strategy. This management strategy, known as "Harmonize" was shown to efficiently manage risk factors in Project Trident (Remote Patient Monitoring Pilot for High Risk Patients, IRB#: 2018-0063-HCP; Nov 2018 - Nov 2020) that aimed to improve control of cardiovascular risk factors in an eldery (mean age = 79 years), racially mixed, primary prevention population (Pulicharam, publication in process).

Adoption of research into a clinical environment depends not only on the efficacy of the therapy, but the quality of the evidence supporting its utilization, and the acceptance of the therapy to patients and caregivers. Major national groups have low level evidence supporting real world approaches to management of these risk factors (USPSTF recommendations "Insufficient" or "B" or "C"). While specifically not developing a guideline, FAR seeks to fill that gap with high quality research data that will inform guidelines and health system approaches to primary prevention, and assess the acceptability of approaches to the affected participant population; leading to dissemination of study results to a real-world setting. By incorporating input from patients, physicians (internal medicine, primary care, and neurology), nurses, and the AHA in the design, implementation, and dissemination of study results, study investigators anticipate good acceptance of study results. FAR will inform key stakeholders (stroke patients, their first-degree relatives, and the healthcare system) regarding the prevalence and impact of family history as an ASCVD risk factor, and how best to mitigate that risk. This effort will be conducted in two phases. During the feasibility phase, the relatives of stroke patients will be assessed regarding their current level of recognition of risk, their willingness to engage in risk measurement, the feasibility of remote monitoring, educational and behavioral factors that would lead to behavior change. Simultaneously, primary care physicians (PCPs) will be assessed regarding perceptions of care gaps, feasibility of use of the chronic disease management technology,20 and design features that might present issues; with development and testing of educational and motivational materials and content. The full-study phase will consist of monitoring the longitudinal thread of integration of the feasibility findings into the main project; initiating the final protocol and assess outcomes; and, activating the Engagement Committee for input into identified study issues.

Conditions

• Stroke
• Hypertension

Interventions

OTHER

Technological Facilitator

See Enhanced Intervention Arm for full description.

OTHER

Standard of Care

Risk factor assessment in first degree relative subjects and implementation of an education program for the randomized participants and their primary care provider.

Sponsors & Collaborators

• Vanderbilt University Medical Center

  lead OTHER

Principal Investigators

• Kenneth J Gaines, MD · Vanderbilt University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-10-31

Primary Completion

2026-10-31

Completion

2026-10-31

Countries

• United States

Study Locations