The RISC Registry--Risk Informed Screening Registry

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-100
SponsorPrecision Health Equity Initiative

About this trial

Chronic diseases such as heart disease, cancer, and diabetes are the leading causes of death and disability in the United States. Six in ten adults have one chronic disease; 4 in 10 have two or more. These are also leading drivers of the nation's $4.1 trillion in annual health care costs.

Cardiovascular disease is the number one cause of death for men and women, cancer is the second largest, with breast cancer being the second largest cause of death in women. Diabetes is the 8th highest cause of death for both men and women.

Routine screening, a focus on prevention, early detection, and patient engagement with proposed care plans, effective surveillance and follow up are some of the most effective ways to reduce the burden of chronic diseases across an individual's lifetime and at the population level.

Estimating dollar costs associated with non-compliance with screening and health management recommendations is complex and variable depending on the specific context, disease, and condition. But there is much evidence to indicate that a significant amount of these annual costs can be mitigated if compliance with health management recommendations increases, and health problems are prevented or detected early.

Access to screening and noncompliance with health management recommendations impact the entire population, but more disparities exist in racial and ethnic minorities and in the historically underserved for cancer, obesity, diabetes and cardiovascular disease.

The overall cost of these disparities in the U.S. has been estimated at around 1.24 trillion U.S. Dollars.

The RISC Registry seeks to pursue the intersection of breast cancer, metabolic, and cardiovascular risk in women and study the application of individualized multi-condition risk assessments, risk-informed or personalized screening, prevention and follow up care approaches in a broad cross section of patients. It pursues the hypothesis that these approaches accompanied by population appropriate methods of clinician and patient engagement may increase understanding and compliance with breast cancer, obesity, and metabolic/cardiovascular/cardiometabolic risk screening, surveillance and follow up recommendations by empowering women to make healthier choices.

In doing so, these methods may identify ways to address disparities in screening and patient care and ultimately promote early detection or even reversal of adverse health conditions, improve overall personal health, and reduce overall health care costs.

The primary focus is cancer, cardiovascular and metabolic health screening with a focus on utilization of Precision Screening. (Precision Screening attempts to separate those who will benefit from screening from those that may not, through use of information on disease risk.)

The study will start by focusing on women and risk for these diseases and health conditions.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Female (Gender assigned at birth)

Unaffected women (by breast cancer, diabetes or cardiovascular disease)

Females who have been diagnosed with breast cancer, diabetes or cardiovascular disease

Females who are presenting for cancer, metabolic health or cardiovascular screening

Disqualifiers

None

Trial population

Inclusive study of women who are seeking screening for breast cancer, cardiovascular disease and cardiometabolic risk

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Breast Cancer, Cardiometabolic, Cardiovascular Risk Screening and Follow up

    Behavioral

    Study of different types of risk-informed screening approaches and the measurement of patient compliance with screening recommendations based on different approaches to patient engagement

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Disease risks and issues identified during multi-condition risk assessment

Types of disease risks or issues identified by implementing a multi-condition risk assessment in a single patient.

Time frame
Within 3 months
2

Objective health measures within different population subgroups--blood pressure

Changes in an individual's blood pressure (both systolic and diastolic) tracked over time associated with different risk assessments, recommended care plans and patient engagement techniques, by different population subgroups. Could include data gathered from connected health devices used as part of the care plan and follow up.

Time frame
Within 6 months
3

Objective health measures within different population subgroups--BMI

Changes in an individual's BMI using combined height and weight measures, tracked over time, associated with different cardiovascular and breast cancer risk assessments, recommended care plans and patient engagement techniques, by different population subgroups.

Time frame
Within 6 months
4

Objective health measures within different population subgroups--HDL levels

Changes (increase or decrease) in an individual's HDL tracked over time associated with different risk assessments, recommended care plans and patient engagement techniques, by different population subgroups.

Time frame
Within 6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: