Research indicates that fewer than half of all patients with elevated low density lipoprotein-Cholesterol (LDL-C) advised to make life style changes and to take HMG-CoA-Reductase inhibitors (i.e. statins) continue to follow the prescribed regimens. This non-adherence results in more cardiovascular events, decreased length and quality of life, and millions of dollars more in health care costs each year. The practical challenge is to develop adherence interventions without increasing demands on already overburdened health care providers and systems. The proposed project will integrate validated behavioral science with interactive technology to develop a highly-scalable solution-The Interactive Cholesterol Advisory Tool (ICAT)-designed to increase the initiation and maintenance of medication adherence and therapeutic lifestyle change in patients at risk for coronary heart disease (CHD) by increasing their autonomous self-regulation and perceived competence. To achieve this, the ICAT will use highly engaging and personalized multimedia technology, capitalizing on the scientifically validated, self-determination-theory (SDT) health behavior model (SDT; Deci and Ryan, 1985, 2000; Patrick, Williams et al., 2008). Specifically, the ICAT will be a virtual environment in which the patient will have a "conversation" with a virtual health care provider (the "ICAT avatar") that will respond meaningfully to patient input and assist in developing an effective care plan based upon clinical guidelines. The ICAT therefore represents significant innovation in integrating a validated model for behavior change into a highly scalable, effective, and efficient technology tool for sustaining coronary health in a broad population. During Phase I of the proposed project, a prototype of the ICAT will be developed to deliver SDTintervention content and to customize responses based upon user input. Usability testing will be conducted at two different points during development to assess both (1) the accurate technical functioning of the ICAT and (2) the ease of use and general perception of the ICAT by users. Following successful achievement of Phase I milestones, during Phase II of the proposed project the ICAT will be fully developed to deliver a complete SDT-based intervention for use in a randomized clinical trial. One hundred (100) participants at moderate or high risk for a CV event within 10 years will compare the effects of a prescriber-plus-ICAT group (n = 50) to a prescriber-standard-care group (n = 50) on (a) reducing levels of LDL-C (primary outcome), and (b) increasing initiation and long-term adherence to statin medications, as measured using Medical Events Monitoring System CAPS (or Memscaps(tm)). Groups will then be compared on two primary dependent measures: (1) improvement in LDL-C and (2) medication adherence. The underlying hypothesis is that the prescriber-plus-ICAT group will (1) have greater improvement in LDL-C and (2) demonstrate greater medication adherence. Upon demonstration of the ICAT's efficacy in a clinical trial, there are numerous segments of the health care market for which the product will have commercial value, given its ability to reach large populations effectively and efficiently.
Public Health Relevance: Fewer than half of all patients with elevated low density lipoprotein-Cholesterol (or "bad" cholesterol: LDL-C) who are advised to make life style changes and to take statin medications continue to follow the prescribed regimen, resulting in more heart attacks, strokes and deaths and increased health care costs. This project will develop an innovative interactive technology, called the Interactive Cholesterol Advisory Tool (ICAT), which is designed to enhance patients' motivation regarding lifestyle change and taking medications for those who are at risk. The value of this tool is that it can reach a broad population of people who are at risk and play a role in sustaining their health and their quality of life.
NIH Spending Category: Behavioral and Social Science; Cardiovascular; Clinical Research; Clinical Trials; Heart Disease; Heart Disease - Coronary Heart Disease; Mind and Body
Project Terms: 3-hydroxy-3-methylglutaryl coenzyme A Inhibitors; Achievement; Achievement Attainment; Adherence; Adherence (attribute); Apoplexy; Behavioral Sciences; Cardiac infarction; Cardiovascular; Cardiovascular Body System; Cardiovascular system; Cardiovascular system (all sites); Caring; Cerebral Stroke; Cerebrovascular Apoplexy; Cerebrovascular Stroke; Cerebrovascular accident; Cessation of life; Cholest-5-en-3-ol (3beta)-; Cholesterol; Clinical; Clinical Trials; Clinical Trials, Unspecified; Competence; Coronary; Coronary Disease; Coronary heart disease; Death; Development; Drugs; Environment; Event; Guidelines; HMG-CoA Reductase Inhibitors; Health; Health Care Costs; Health Care Providers; Health Costs; Health Personnel; Health behavior; Healthcare Costs; Healthcare Market; Healthcare Providers; Healthcare worker; Hydroxymethylglutaryl CoenzymeA Reductase Inhibitors; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Informal Social Control; Inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase; Inhibitors, Hydroxymethylglutaryl-CoA; Inhibitors, Hydroxymethylglutaryl-Coenzyme A; Intervention; Intervention Strategies; LDL Cholesterol; LDL Cholesterol Lipoproteins; Length; Life Style; Lifestyle; Low Density Lipoprotein Cholesterol; Maintenance; Maintenances; Markets, Health Care; Measures; Medical; Medication; Modeling; Monitor; Motivation; Multimedia; Multimedium; Myocardial Infarct; Myocardial Infarction; Organ System, Cardiovascular; Participant; Patients; Perception; Pharmaceutic Preparations; Pharmaceutical Preparations; Phase; Play; Population; Protocols, Treatment; QOL; Quality of life; RGM; Randomized Clinical Trials; Regimen; Research; Risk; Role; Self Determination; Self Regulation; Social Control, Informal; Solutions; Statins, HMG-CoA; Stroke; System; System, LOINC Axis 4; Technology; Testing; Treatment Protocols; Treatment Regimen; Treatment Schedule; Vascular Accident, Brain; Vascular, Heart; base; behavior change; beta-Lipoprotein Cholesterol; brain attack; cardiac infarct; cerebral vascular accident; circulatory system; clinical investigation; coronary attack; coronary disorder; coronary infarct; coronary infarction; design; designing; drug/agent; health care personnel; health care worker; health provider; healthcare personnel; heart attack; heart infarct; heart infarction; high risk; innovate; innovation; innovative; interventional strategy; medical personnel; medication adherence; medication compliance; primary outcome; prototype; public health relevance; response; social role; stroke; theories; therapeutic lifestyle change; tool; treatment provider; usability; virtual
