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Randomized controlled trials of positive affect and self-affirmation to facilitate healthy behaviors in patients with cardiopulmonary diseases: rationale, trial design, and methods
Charlson, Mary E; Boutin-Foster, Carla; Mancuso, Carol A; Peterson, Janey C; Ogedegbe, Gbenga; Briggs, William M; Robbins, Laura; Isen, Alice M; Allegrante, John P
Secondary prevention of adverse outcomes in patients with cardiopulmonary disease requires that patients become actively engaged in self-management efforts such as participation in physical activity or medication adherence. However, despite assiduous efforts to find strategies that help cardiovascular patients to adopt and maintain such behaviors, many studies of interventions designed to improve physical activity and adherence to medication have shown disappointing results. To this end, the Translational Behavioral Science Research Consortium was created by the National Heart, Lung, and Blood Institute to identify promising, but underutilized findings from basic behavioral science that might have potential application for translation to clinical populations where behavioral change has been refractory to standard intervention approaches. This paper describes the rationale and methods of a novel research project designed to test the efficacy of a behavioral intervention that combines constructs from two behavioral science theories (positive affect and self-affirmation) in order to help patients with coronary artery disease, asthma, and hypertension successfully change behaviors. The project consists of an intervention framed upon positive affect and self-affirmation and tested in three concurrent randomized controlled trials among three distinct populations. Each trial had a qualitative phase that served as a formative stage to inform the intervention; a pilot phase during which the feasibility of the intervention was tested and refined; and a randomized controlled phase conducted to investigate the effects of the interventions in these three patient groups
PMID: 17459784
ISSN: 1551-7144
CID: 90461
Appointment-keeping behavior is not related to medication adherence in hypertensive African Americans
Ogedegbe, Gbenga; Schoenthaler, Antoinette; Fernandez, Senaida
OBJECTIVE: The relationship between appointment-keeping behavior, medication adherence (ADH), and systolic and diastolic blood pressure (SBP and DBP) was assessed in 153 hypertensive African Americans followed in a community-based practice. METHODS: ADH was assessed with a self-report questionnaire. BP was obtained from electronic medical records and appointment attendance was determined from the log of all appointments made during the 12-month study period. Nonadherence rates were compared across appointment attendance categories with chi-square. Logistic regression was used to assess the relationship between ADH and appointment attendance, whereas multivariate analysis of covariance (MANCOVA) was used to examine the relationship between appointment attendance and BP. RESULTS: Twenty-five percent of patients (87% women, mean age 52 years) did not miss any appointments, 44% missed 1-30%, and 31% missed greater than 30%. Adjusted nonadherence rates were similar for all 3 categories (70%, 66%, and 65%, respectively, p = 0.88) as were adjusted mean SBP and DBP in the MANCOVA model, [F (4, 218) = 1.13, p = .34]. Logistic regression analysis did not indicate a significant relationship between appointment attendance and ADH. CONCLUSIONS: Appointment-keeping behavior was not related to ADH or BP among hypertensive African Americans. It should not be used as a proxy for ADH in this patient population
PMCID:2305751
PMID: 17549574
ISSN: 1525-1497
CID: 78410
The impact of perceived hypertension status on anxiety and the white coat effect
Spruill, Tanya M; Pickering, Thomas G; Schwartz, Joseph E; Mostofsky, Elizabeth; Ogedegbe, Gbenga; Clemow, Lynn; Gerin, William
BACKGROUND: The white coat effect can lead to overdiagnosis of hypertension and unnecessary pharmacologic treatment. Mechanisms underlying the white coat effect remain poorly understood but are critical to improving the accuracy of clinic blood pressure measurement. PURPOSE: This study investigated whether perceived hypertension status was associated with state anxiety levels during a clinic visit and the magnitude of the white coat effect, independent of true blood pressure status. METHODS: This observational study included 214 normotensive and mildly hypertensive participants who were 18 to 80 years old, had no cardiac history, and were willing to discontinue antihypertensive medications for 8 weeks. Participants underwent 36 hr ambulatory blood pressure monitoring and physician blood pressure measurement. Outcome measures were state anxiety reported during the clinic visit and the white coat effect. RESULTS: An analysis of covariance indicated that participants who perceived themselves as hypertensive reported greater state anxiety (p<.001) and showed larger white coat effects (ps<.01) compared with those who perceived themselves as normotensive. True hypertension status based on ambulatory blood pressure was not related to either outcome. Anxiety accounted for approximately 19% of the association between perceived hypertension status and the white coat effect. CONCLUSIONS: These findings suggest that the perception of being hypertensive is associated with greater anxiety during clinic blood pressure measurement and a larger white coat effect, independent of the true blood pressure level. Anxiety appears to be a mechanism by which perceived hypertension status contributes to the white coat effect
PMID: 17688391
ISSN: 0883-6612
CID: 90459
The medication Adherence and Blood Pressure Control (ABC) trial: a multi-site randomized controlled trial in a hypertensive, multi-cultural, economically disadvantaged population
Gerin, William; Tobin, Jonathan N; Schwartz, Joseph E; Chaplin, William; Rieckmann, Nina; Davidson, Karina W; Goyal, Tanya M; Jhalani, Juhee; Cassells, Andrea; Feliz, Karina; Khalida, Chamanara; Diaz-Gloster, Marleny; Ogedegbe, Gbenga
The Medication Adherence and BP Control Trial (ABC Trial) is a randomized, controlled, multi-site, medication adherence and blood pressure (BP) control trial in an economically disadvantaged and multi-cultural population of hypertensive patients followed in primary care practices. To date, no other such trial has been published in which objective measures of adherence (electronic pill bottles) were used to assess the effectiveness of these behavioral interventions for hypertension. This study tested a combination of commercially-available interventions that can be easily accessed by health care providers and patients, and therefore may provide a real-world solution to the problem of non-adherence among hypertensives. The aim of the ABC Trial was to test the effectiveness of a stepped care intervention in improving both medication adherence to an antihypertensive medication regimen and BP control. Step 1 of the intervention employed home Self-BP Monitoring (SBPM); at this stage, there were two arms: (1) Usual Care (UC) and (2) Intervention. At Step 2, patients in the intervention arm whose BP had not come under control after 3 months were further randomized to one of two conditions: (1) continuation of SBPM (alone) or (2) continuation of SBPM plus telephone-based nurse case management (SBPM+NCM). Electronic Medication Event Monitoring (MEMS) was the primary measure of medication adherence, and in-office BP was the primary measure of hypertension control. We present an overview of the study design, details of the administrative structure of the study and a description of clinical site recruitment, patient recruitment, and follow-up assessments
PMID: 17287150
ISSN: 1551-7144
CID: 90463
African American spirituality: a process of honoring God, others, and self
Lewis, Lisa M; Hankin, Sheila; Reynolds, Diane; Ogedegbe, Gbenga
PURPOSE: The purpose of this pilot study was to explore African American definitions of practicing spirituality and to describe the process of spirituality and its relationship to health promotion. METHOD: Data were collected using semi-structured interview questions via two focus groups from a total of 12 participants who self-identified as African American. FINDINGS: This grounded theory methodology generated three categories of spirituality: (a) love in action, (b) relationships and connections, and (c) unconditional love. The overall process of practicing spirituality and its relationship to health identified a process of honoring God, self, and others. CONCLUSION: Research studies that investigate the concept of spirituality and its relationship to health promotion and disease management need to address the subjective experience of spirituality based on participant definitions rather than researcher-focused definitions of spirituality
PMID: 17325309
ISSN: 0898-0101
CID: 90462
An RCT of the effect of motivational interviewing on medication adherence in hypertensive African Americans: rationale and design
Ogedegbe, Gbenga; Schoenthaler, Antoinette; Richardson, Tabia; Lewis, Lisa; Belue, Rhonda; Espinosa, Eugenia; Spencer, Jacqueline; Allegrante, John P; Charlson, Mary E
BACKGROUND: Hypertension disproportionately affects African Americans compared to whites, and it is the single most common explanation for the disparity in mortality between African Americans and whites. Adherence with antihypertensive medications can help reduce risk of negative hypertension-related outcomes. Motivational interviewing is a promising patient-centered approach for improving adherence in patients with chronic diseases. In this paper we describe the rationale and design of an ongoing randomized controlled trial testing the effectiveness of motivational interviewing versus usual care in improving medication adherence among 190 African American uncontrolled hypertensive patients, who receive care in a primary care setting. METHODS: The usual care group receives standard medical care, while those in the intervention group receive standard care plus four sessions of motivational interviewing at 3-month intervals for a period of 1 year. This technique consists of brief, patient-driven counseling sessions to facilitate initiation and maintenance of behavior change. The primary outcome is adherence to prescribed antihypertensive medication, assessed with the electronic medication events monitoring system (MEMS) and the Morisky self-report adherence questionnaire. Secondary outcomes are within-patient changes in blood pressure, self-efficacy, and intrinsic motivation between baseline and 12 months. We report the baseline sociodemographic and clinical characteristics of the participants. CONCLUSIONS: Despite the potential utility of motivational interviewing, little is known about its effectiveness in improving medication adherence among hypertensive patients, especially African Americans. In addition to the baseline data this study has generated, this trial should provide data with which we can assess the effectiveness of this approach as a behavioral intervention
PMID: 16765100
ISSN: 1551-7144
CID: 83563
Ascribing meaning to hypertension: a qualitative study among African Americans with uncontrolled hypertension
Boutin-Foster, Carla; Ogedegbe, Gbenga; Ravenell, Joseph E; Robbins, Laura; Charlson, Mary E
OBJECTIVE: The objective was to elicit patients' perceptions regarding the meaning of hypertension and to identify the personal, social, and environmental factors that might influence their perceptions. DESIGN: Qualitative study. SETTING: Adult ambulatory care practice PARTICIPANTS: African American patients with uncontrolled hypertension. INTERVENTION/METHODS: In-depth structured interviews were conducted with a purposive sample of 60 patients. Interviews were audiotaped, transcribed verbatim, and analyzed by using grounded theory. RESULTS: Patient descriptions of hypertension were grouped into three categories: 1) their thoughts on hypertension; 2) the consequences of hypertension; and 3) the impact that having hypertension had on their lifestyle. Factors that might have shaped how patients described hypertension were grouped into three categories: 1) the experiences of their social networks such as family and friends; 2) their personal experiences; and 3) information about hypertension that they might have gathered from the medical literature or during an encounter with a healthcare provider. Patients with family members who had experienced hypertension-related complications such as stroke were more likely to view hypertension as a serious condition. Patients who themselves experienced hypertension-related symptoms and who also had family members with a history of hypertensive disease were more likely to describe a willingness to make lifestyle changes. CONCLUSIONS: In this study, personal experiences, experiences of family and friends, and encounters with the healthcare environment influenced patients' perceptions of hypertension and their willingness to make lifestyle changes. These findings can be used as a framework for helping to tailor effective and culture-specific interventions
PMID: 17274206
ISSN: 1049-510x
CID: 79437
Superiority of ambulatory to physician blood pressure is not an artifact of differential measurement reliability
Gerin, William; Schwartz, Joseph E; Devereux, Richard B; Goyal, Tanya; Shimbo, Daichi; Ogedegbe, Gbenga; Rieckmann, Nina; Abraham, Dennis; Chaplin, William; Burg, Matthew; Jhulani, Juhee; Pickering, Thomas G
BACKGROUND: Ambulatory blood pressure is a better predictor of target organ damage and the risk of adverse cardiovascular events than office measurements. Whether this is due to the greater reliability owing to the larger number of measurements that are usually taken using ambulatory monitoring, or the greater validity of these measurements independent of the number, remains controversial. METHODS: We addressed this issue by comparing physician readings and ambulatory measurements as predictors of left ventricular mass index. The number of readings was controlled by using the average of three physician readings and randomly selecting three awake readings from a 24-h ambulatory recording. RESULTS: In a multiple regression analysis that included both the ambulatory and physician blood pressure measurements, only the ambulatory systolic measurements significantly predicted left ventricular mass index (B=0.37, t=3.11, P=0.002); the coefficient for physician's systolic measurements was essentially zero (B=-0.01, t=-0.26, NS). CONCLUSIONS: These findings suggest that the superiority of ambulatory blood pressure as a predictor of target organ damage, compared with physician measurements, cannot be adequately/fully explained by the impact of the larger number of measurements obtained with ambulatory monitoring
PMID: 17106312
ISSN: 1359-5237
CID: 90464
A systematic review of the effects of home blood pressure monitoring on medication adherence
Ogedegbe, Gbenga; Schoenthaler, Antoinette
Home blood pressure monitoring (HBPM) improves blood pressure control, but little is known about its effects on medication adherence. The authors conducted a systematic review of the published literature on the effects of HBPM on medication adherence. Of 440 abstracts and citations reviewed, 11 randomized control trials met predefined criteria. Six of the 11 randomized controlled trials reported statistically significant improvement in medication adherence; 84% of these were complex interventions involving the use of HBPM in combination with other adherence-enhancing strategies such as patient counseling by nurses, pharmacists, or a telephone-linked system; patient education; and the use of timed medication reminders. Interventions conducted in primary care settings were not effective compared with those that occurred in hospital-based clinics or nonclinical settings. The data on the effects of HBPM on patients' medication-taking behavior are mixed. Future studies should investigate the independent effects of HBPM in primary care practices where the majority of hypertensive patients receive their care
PMID: 16522994
ISSN: 1524-6175
CID: 83564
Assessment of the white-coat effect
Gerin, William; Ogedegbe, Gbenga; Schwartz, Joseph E; Chaplin, William F; Goyal, Tanya; Clemow, Lynn; Davidson, Karina W; Burg, Matthew; Lipsky, Shira; Kentor, Rebecca; Jhalani, Juhee; Shimbo, Daichi; Pickering, Thomas G
BACKGROUND: A limitation of blood pressure measurements made in the physician's office is the transient elevation in pressure seen in many patients that does not appear to be linked to target organ damage or prognosis. This has been labeled the 'white-coat effect' (WCE), computed as the difference between blood pressure measurements taken by the physician and the ambulatory level or resting measures. It is unclear, however, which resting measure is most appropriate. The awake ambulatory blood pressure is the most widely used. However, while arguably the most useful measure for prediction of clinical outcomes, it is less appropriate for use as a resting measure, because it is influenced by many factors, including posture and physical activity level. Resting levels taken in the clinic may also be elevated, and will therefore underestimate the WCE. METHODS: We addressed this question by taking resting measures in a non-medical setting on the day before patients were seen at a Hypertension Clinic (day 1), and comparing these with resting measures taken on the following day, in the clinic before the patient saw the physician. RESULTS: As predicted, the day 1 resting levels were lower than those taken in the clinic prior to seeing the physician (P < 0.05 and P < 0.001 for systolic and diastolic pressures, respectively) in both normotensive and hypertensive patients. Using the day 1 resting levels, the estimated WCE for hypertensive patients was 5.3/6.9 mmHg (systolic/diastolic blood pressures), compared with estimates, using the clinic resting levels, of 0.3/0.5 mmHg. The pattern of changes was different in normotensive patients and hypertensive patients, with the physician pressures being slightly lower than day 1 pressures in the former, and substantially higher in the latter. Heart rate changes were similar and modest in both groups. CONCLUSION: The WCE may not just be limited to that narrow interval in which the patient actually sees the physician, but may generalize to the clinic setting, rendering a clinic 'resting' level invalid. While it is strongly positive in most hypertensive patients, it is frequently negative in normotensive patients. Our results suggest that improved methods of measuring blood pressure in the clinic setting are unlikely to resolve the confounding influence of the WCE, and that greater reliance will need to be placed on out-of-office monitoring
PMID: 16331103
ISSN: 0263-6352
CID: 90465