William Gerin, Ph.D. - US grants

This proposal presents a series of laboratory studies designed to answer questions concerning the role of psychosocial factors in the development of hypertension and related cardiovascular disease. Four studies are proposed. The first 3 focus on effects of active coping and social support in normotensive and borderline hypertensive subjects. Study 4 is concerned with a possible cause of White Coat Hypertension. Studies 1-3 follow up our findings which show that ability to cope reduces blood pressure and heart rate reactivity, when the effortfulness of the task is controlled. Many studies show that ability to cope increases reactivity; however, in those studies effort co-varies with the enhanced control due to availability of a coping response. Studies 1 and 2 test the proposition that active coping is a function of (at least) 2 separate components--enhanced control and effortfulness--which we hypothesize have opposite effects on reactivity. In addition, we test the proposition that social support represents a special case of ability to cope, and therefore may exert its reactivity-reducing effects because of its control-enhancing aspects, as would other available coping responses. In addition, we propose that reactivity differences between normotensive and borderline hypertensive populations can be better understood when differences in the response to each of the components of active coping--enhanced control and effort--are examined individually. In Study 4, we propose to follow up on pilot data in which we have observed that a proportion of young normotensives show an anticipatory rise in blood pressure (taken using a finger-cuff attached to a Finapres Monitor), prior to the entry into the room of an MD. We hypothesize that these anticipatory responses are (1) related to the subject's history of medical experiences; (2) related to the White Coat response seen in older patients; and (3) is not simply an instance of generalized reactivity. In order to test these propositions, we propose to examine the subjects in the laboratory (in order to determine anticipator status, and perform general reactivity tests) as well as in the medical clinic, where responses to the MD can be observed.

This proposal presents a series of laboratory studies designed to answer questions concerning the role of psychosocial factors in the development of hypertension and related cardiovascular disease. Four studies are proposed. The first 3 focus on effects of active coping and social support in normotensive and borderline hypertensive subjects. Study 4 is concerned with a possible cause of White Coat Hypertension. Studies 1-3 follow up our findings which show that ability to cope reduces blood pressure and heart rate reactivity, when the effortfulness of the task is controlled. Many studies show that ability to cope increases reactivity; however, in those studies effort co-varies with the enhanced control due to availability of a coping response. Studies 1 and 2 test the proposition that active coping is a function of (at least) 2 separate components--enhanced control and effortfulness--which we hypothesize have opposite effects on reactivity. In addition, we test the proposition that social support represents a special case of ability to cope, and therefore may exert its reactivity-reducing effects because of its control-enhancing aspects, as would other available coping responses. In addition, we propose that reactivity differences between normotensive and borderline hypertensive populations can be better understood when differences in the response to each of the components of active coping--enhanced control and effort--are examined individually. In Study 4, we propose to follow up on pilot data in which we have observed that a proportion of young normotensives show an anticipatory rise in blood pressure (taken using a finger-cuff attached to a Finapres Monitor), prior to the entry into the room of an MD. We hypothesize that these anticipatory responses are (1) related to the subject's history of medical experiences; (2) related to the White Coat response seen in older patients; and (3) is not simply an instance of generalized reactivity. In order to test these propositions, we propose to examine the subjects in the laboratory (in order to determine anticipator status, and perform general reactivity tests) as well as in the medical clinic, where responses to the MD can be observed.

This is a proposal to refine and evaluate a new technology designed to improve hypertension care, at less than the current cost. Hypertension is one of the commonest medical conditions, affecting about heart disease. It cost about $18.7 billion to treat hypertension in the US in 1995. Despite the large number of effective antihypertensive drugs, and clear evidence that their use can reduce morbidity associated with hypertension, only an estimated one in four Americans with high blood pressure has it well controlled. This is a proposal to integrate a clinical-grade electronic home blood pressure monitor with a very low-cost proprietary teletransmission system which we have developed, to enable patients to easily send blood pressure and heart rate data to physicians over ordinary telephone lines. These user-friendly technologies will be imbedded in an automated information management system which will shift the site of care from clinic to home, and improve the ability of both physicians and patients to assess and manage hypertension. We project a $5/month cost to the user for the entire system, including monitor and telecommunications. PROPOSED COMMERCIAL APPLICATION: Our service will allow managed care companies to reduce the cost of treating hypertension by improving patient compliance with therapy, cutting unneeded care for people with White Coat hypertension (high blood pressure only in the MD's office, estimated at 20% of patients), identifying noncompliant or poorly-controlled patients, and shifting the site of care from MD's office to patient's home. Our initial market: group-staff HMOs (15 million covered lives, 1.25 million hypertensives).

DESCRIPTION (investigator's abstract): We propose to conduct a randomized controlled trial in a multicultural population of uncontrolled, hypertensive patients to test the effectiveness of a stepped-care intervention involving 2 stages: (1) Self-Telemonitoring (STM) of blood pressure (BP) which uses a telephone transmission system by which an easy-to-use modem, contained in the BP monitor, sends the BP measurements to a commercial service (Lifelink Monitoring) who then sends the measurements to the patient's health care provider; and (2) Telephone-Based Nurse Case Management (NCM), provided by a commercially available service (U-Med). The nurse case managers will call patients once/month, and provide counseling regarding BP control, and adherence to medication regimens. All patients in the intervention condition will begin with STM; after 3 months, patients whose BP has come under control remain in the STM condition; patients whose BP remain uncontrolled are then randomized, half to NCM + Self-Telemonitoring; the other half to continue in STM only (the design allows us to evaluate the effects of each arm of the intervention separately, and the combination; in addition, there will be a Usual Care condition). The focus is on an intervention strategy which readily transfers to a variety of usual health care situations. Both interventions are commercially available, and therefore are accessible to a wide range of health care providers, including smaller community-based clinics. An innovative aspect of the intervention is that the 2 commercial services will work together; the nurse case managers will receive BP reports from Lifelink, which the nurse will then use as a basis for counseling. We will test the effectiveness of the interventions in 12 community-based clinics, which serve an economically disadvantaged, largely African American and Hispanic population, in New York City. The main outcome measures are medication adherence, determined by electronic drug event monitoring (MEMS), and pharmacy refill records, as well as BP control. Study duration is 1 year. The multilevel focus of the interventions is on provider as well as patient behavior. We will conduct reviews for each patient at study discharge, recording data on clinic BP measurements during the previous 12 months, if any, doctor appointments, ER visits, medication changes, and evidence that the physician has responded to the interventions. The long-term goals of the research are to assess the medical and cost effectiveness of the interventions separately, and combined.

The purpose of this core is to add the study of causal mechanisms by which stress, emotions, and cognitions can contribute to the development of hypertension (HTN) and chronic cardiovascular diseases (CVD) to already existing Behavioral Medicine (BM) randomized controlled trials (RCTs). A set of psychometric measures that assess Cognitive Adaptation theory (CA) and a set of biochemical and physiological measures that assess the AIIostatic Load (AL) model will be standardized to create two batteries. These two theories and their associated measures were selected because they both argue that there is a common mechanism by which the effects of stress impact upon health and disease outcome. The corollary of this argument is that BM interventions, while utilizing distinct treatments, all operate to reduce stress and impact upon health through one common pathway. Alternatively, there may be one unique mechanism associated with each type of BM intervention. This core will allow us to test these conjectures about the ways in which BM RCTs impacts disease. The proposed mechanisms battery will initially be assessed pre- and post-intervention in three currently funded behavioral RCTs in which common mechanism hypotheses were not originally included. We have chosen three RCTs that are testing how stress, anger, and motivational interviewing interventions impact upon blood pressure. Additionally, this standardized battery will be made available to other RCTs that are either ongoing or planned.

DESCRIPTION (provided by applicant): Patients'knowledge concerning their chronic illness has long been considered "necessary but not sufficient" to produce changes in risk-related behaviors. "Necessary" implies that patient knowledge is, therefore, a moderator of the effectiveness of behavioral interventions. However, researchers have tended to ignore patient education as a critical component of behavioral (or, for that matter, pharmacological) interventions. We propose to combine a behavioral intervention that we and others have found to be moderately effective in increasing blood pressure (BP) control in hypertensive patients - using a home BP monitor (HBPM) to obtain feedback regarding their BP control, and providing feedback to the health provider - with a systematic patient education component. We propose an intervention strategy that is meant to be usable as an adjunct to the HBPM and other interventions;one that will increase patients'knowledge, and, we hypothesize, will therefore increase the effectiveness of the "parent" intervention (HBPM, in this case). Our proposal is for a randomized controlled trial (RCT), using a 2X2 factorial design in which we will test the effect of (1) a patient education intervention and (2) HBPM, on ambulatory BP in poorly-controlled hypertensive patients at 3 and 6 months. The education intervention is based on a technique called "Self-Paced Programmed Instruction" (SPPI), a method that has been remarkably effective at increasing knowledge concerning complex topics. Using a computer, a paragraph of content material is presented, followed by probe questions. When patients provide a correct response, they are immediately reinforced by positive feedback;an incorrect response loops the program to re-present the materials, this time with hints;and the subjects then re-attempt the probe questions. The loop continues until a correct answer is recorded. In this manner, every subject achieves mastery over the requisite material. We posit that medication adherence (assessed objectively) will partially mediate the ambulatory BP outcomes;and that Self-Efficacy for the self- management of HTN will mediate medication adherence;we predict that self-efficacy will be enhanced by the mastery of the HTN-related materials, and by the reduction of ambiguity, which will lead to greater confidence in the patient's decision-making processes. We predict that the SPPI - HBPM condition will have the greatest effect on ambulatory BP, compared to the other three groups. PUBLIC HEALTH RELEVANCE: Hypertension remains a hugely costly problem in the United States in terms of morbidity and economic burden. Many patients cannot or will not take medications;the application proposes a non-pharmacological intervention that will help hypertensive patients adhere to their prescribed medication regimens, and to control their blood pressure.

CHUM RESEARCH CORE Core Leaders: Jean Teresi, Ph.D. (Hebrew Home for the Aged) William Gerin, Ph.D. (Columbia University) Co-Investigator: Rafael Lantigua, M.D. Abstract The purpose of the Research Core is to provide a mechanism to foster communications among the three large Research Projects;and to centralize those resources that are common to the three projects, including randomization implementation, subject and data tracking, data entry, data quality (i.e. ,outlier detection, artifact detection, imputation of missing values), and statistical analysis. Dr. Teresi, who is the Leader of this core, is an accomplished statistician and director of a data management team, and she will hold responsibility for the processing of data and analysis. Drs. Gerin and Lantigua will develop mechanisms for review and quality assurance of methodological procedures for the two Randomized Controlled Trials and the epidemiological study.