Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04607876
Status:
WITHDRAWN
Last Update Posted:
2022-03-21
First Post:
2020-10-22
Brief Title:
Family at Risk Study
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Family at Risk Study
Status:
WITHDRAWN
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study not funded
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FAR
Brief 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 optimal1-3 Hypertension affects approximately 30 of adults and the US Preventive Services Task Force USPSTF supports population screening4 Many individuals have multiple risk factors with declining rates of control with an increasing numbers of risk factors5 but greater benefit through the control of multiple risk factors6 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 risk12-14 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-riskhigh-motivation population of the biological offspring and siblings of an index stroke patient FAR will evaluate two strategies for risk factor control 1 FAR-EducationCoaching Arm FAR-EC Arm providing education from the American HeartAmerican Stroke Association AHAASA 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 HealthStreamHarmonize 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 technology20 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
The Family at Risk FAR Trial targets this high-riskhigh-motivation population of the biological offspring and siblings of an index stroke patient FAR will evaluate two strategies for risk factor control 1 FAR-EducationCoaching Arm FAR-EC Arm providing education from the American HeartAmerican Stroke Association AHAASA 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 HealthStreamHarmonize 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 technology20 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
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None