Counseling African Americans to Control Hypertension: cluster-randomized clinical trial main effects.

BACKGROUND: Data are limited on the implementation of evidence-based multilevel interventions targeted at blood pressure (BP) control in hypertensive blacks who receive care in low-resource primary care practices. METHODS AND RESULTS: Counseling African Americans to Control Hypertension is a cluster-randomized clinical trial in which 30 community health centers were randomly assigned to the intervention condition (IC) or usual care (UC). Patients at the IC sites received patient education, home BP monitoring, and monthly lifestyle counseling, whereas physicians attended monthly hypertension case rounds and received feedback on their patients' home BP readings and chart audits. Patients and physicians at the UC sites received printed patient education material and hypertension treatment guidelines, respectively. The primary outcome was BP control, and secondary outcomes were mean changes in systolic and diastolic BPs at 12 months, assessed with an automated BP device. A total of 1059 patients (mean age, 56 years; 28% men, 59% obese, and 36% with diabetes mellitus) were enrolled. The BP control rate was similar in both groups (IC=49.3% versus UC=44.5%; odds ratio, 1.21 [95% confidence interval, 0.90-1.63]; P=0.21). In prespecified subgroup analyses, the intervention was associated with greater BP control in patients without diabetes mellitus (IC=54.0% versus UC=44.7%; odds ratio, 1.45 [confidence interval, 1.02-2.06]); and small-sized community health centers (IC=51.1% versus UC=39.6%; odds ratio, 1.45 [confidence interval, 1.04-2.45]). CONCLUSIONS: A practice-based, multicomponent intervention was no better than UC in improving BP control among hypertensive blacks. Future research on the implementation of behavioral modification strategies for hypertension control in low-resource settings should focus on the development of more efficient and tailored interventions in this high-risk population. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00233220.

The Counseling Older Adults to Control Hypertension (COACH) trial: design and methodology of a group-based lifestyle intervention for hypertensive minority older adults.

The disproportionately high prevalence of hypertension and its associated mortality and morbidity in minority older adults is a major public health concern in the United States. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes on blood pressure reduction, these approaches remain largely untested among minority elders in community-based settings. The Counseling Older Adults to Control Hypertension trial is a two-arm randomized controlled trial of 250 African-American and Latino seniors, 60 years and older with uncontrolled hypertension, who attend senior centers. The goal of the trial is to evaluate the effect of a therapeutic lifestyle intervention delivered via group classes and individual motivational interviewing sessions versus health education, on blood pressure reduction. The primary outcome is change in systolic and diastolic blood pressure from baseline to 12 months. The secondary outcomes are blood pressure control at 12 months; changes in levels of physical activity; body mass index; and number of daily servings of fruits and vegetables from baseline to 12 months. The intervention group will receive 12 weekly group classes followed by individual motivational interviewing sessions. The health education group will receive an individual counseling session on healthy lifestyle changes and standard hypertension education materials. Findings from this study will provide needed information on the effectiveness of lifestyle interventions delivered in senior centers. Such information is crucial in order to develop implementation strategies for translation of evidence-based lifestyle interventions to senior centers, where many minority elders spend their time, making the centers a salient point of dissemination.

Telephone care coordination for smokers in VA mental health clinics: protocol for a hybrid type-2 effectiveness-implementation trial.

BACKGROUND: This paper describes an innovative protocol for a type-II hybrid effectiveness-implementation trial that is evaluating a smoking cessation telephone care coordination program for Veterans Health Administration (VA) mental-health clinic patients. As a hybrid trial, the protocol combines implementation science and clinical trial methods and outcomes that can inform future cessation studies and the implementation of tobacco cessation programs into routine care. The primary objectives of the trial are (1) to evaluate the process of adapting, implementing, and sustaining a smoking cessation telephone care coordination program in VA mental health clinics, (2) to determine the effectiveness of the program in promoting long-term abstinence from smoking among mental health patients, and (3) to compare the effectiveness of telephone counseling delivered by VA staff with that delivered by state quitlines. METHODS/DESIGN: The care coordination program is being implemented at six VA facilities. VA mental health providers refer patients to the program via an electronic medical record consult. Program staff call referred patients to offer enrollment. All patients who enroll receive a self-help booklet, mailed smoking cessation medications, and proactive multi-call telephone counseling. Participants are randomized to receive this counseling from VA staff or their state's quitline. Four primary implementation strategies are being used to optimize program implementation and sustainability: blended facilitation, provider training, informatics support, and provider feedback. A three-phase formative evaluation is being conducted to identify barriers to, and facilitators for, program implementation and sustainability. A mixed-methods approach is being used to collect quantitative clinical effectiveness data (e.g., self-reported abstinence at six months) and both quantitative and qualitative implementation data (e.g., provider referral rates, coded interviews with providers). Summative data will be analyzed using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework. DISCUSSION: This paper describes the rationale and methods of a trial designed to simultaneously study the clinical effectiveness and implementation of a telephone smoking cessation program for smokers using VA mental health clinics. Such hybrid designs are an important methodological design that can shorten the time between the development of an intervention and its translation into routine clinical care.

Utility of the abbreviated Fuld Object Memory Evaluation and MMSE for detection of dementia and cognitive impairment not dementia in diverse ethnic groups.

To address the growing need for ethnically unbiased cognitive screening, we examined whether the Mini Mental State Exam (MMSE), the abbreviated Fuld Object Memory Evaluation (FOME), or a combination of the two provided optimal detection of dementia in an ethnically diverse group of older adults with no cognitive impairment (normal); cognitive impairment not dementia (CIND); and dementia. Participants included 509 Caucasians, 124 African Americans, and 68 Latinos (>70 years old) from the Aging, Demographics, and Memory Study who completed the MMSE and FOME. Empirically derived decision trees were computed using signal detection software for receiver operator characteristics (ROC). Among the three ethnic groups, ROC analyses revealed that lower scores on both the MMSE and FOME provided better detection of CIND or dementia. Sensitivity and specificity of the MMSE was augmented by the addition of the FOME among Caucasian and African American older adults. The MMSE alone was the best screen in Latino older adults to distinguish any cognitive impairment from normal. When comparing CIND versus dementia, however, the FOME alone was best for detecting dementia among Latinos. The abbreviated FOME is recommended to increase clinical validity and thus minimize ethnic biases when administering the MMSE to Caucasian and African American older adults. The MMSE alone is preferred for older Latinos unless comparing CIND and dementia, in which case the FOME alone would then be recommended. Findings suggest that ethnicity is important in the selection of an appropriate cognitive screen and cut-score to use with older adults.

The counseling African Americans to Control Hypertension (CAATCH) Trial: baseline demographic, clinical, psychosocial, and behavioral characteristics.

BACKGROUND: Effectiveness of combined physician and patient-level interventions for blood pressure (BP) control in low-income, hypertensive African Americans with multiple co-morbid conditions remains largely untested in community-based primary care practices. Demographic, clinical, psychosocial, and behavioral characteristics of participants in the Counseling African American to Control Hypertension (CAATCH) Trial are described. CAATCH evaluates the effectiveness of a multi-level, multi-component, evidence-based intervention compared with usual care (UC) in improving BP control among poorly controlled hypertensive African Americans who receive primary care in Community Health Centers (CHCs). METHODS: Participants included 1,039 hypertensive African Americans receiving care in 30 CHCs in the New York Metropolitan area. Baseline data on participant demographic, clinical (e.g., BP, anti-hypertensive medications), psychosocial (e.g., depression, medication adherence, self-efficacy), and behavioral (e.g., exercise, diet) characteristics were gathered through direct observation, chart review, and interview. RESULTS: The sample was primarily female (71.6%), middle-aged (mean age = 56.9 ± 12.1 years), high school educated (62.4%), low-income (72.4% reporting less than $20,000/year income), and received Medicaid (35.9%) or Medicare (12.6%). Mean systolic and diastolic BP were 150.7 ± 16.7 mm Hg and 91.0 ± 10.6 mm Hg, respectively. Participants were prescribed an average of 2.5 ± 1.9 antihypertensive medications; 54.8% were on a diuretic; 33.8% were on a beta blocker; 41.9% were on calcium channel blockers; 64.8% were on angiotensin converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs). One-quarter (25.6%) of the sample had resistant hypertension; one-half (55.7%) reported medication non-adherence. Most (79.7%) reported one or more co-morbid medical conditions. The majority of the patients had a Charlson Co-morbidity score ≥ 2. Diabetes mellitus was common (35.8%), and moderate/severe depression was present in 16% of participants. Participants were sedentary (835.3 ± 1,644.2 Kcal burned per week), obese (59.7%), and had poor global physical health, poor eating habits, high health literacy, and good overall mental health. CONCLUSIONS: A majority of patients in the CAATCH trial exhibited adverse lifestyle behaviors, and had significant medical and psychosocial barriers to adequate BP control. Trial outcomes will shed light on the effectiveness of evidence-based interventions for BP control when implemented in real-world medical settings that serve high numbers of low-income hypertensive African-Americans with multiple co-morbidity and significant barriers to behavior change.

A dietary behaviors measure for use with low-income, Spanish-speaking Caribbean Latinos with type 2 diabetes: the Latino Dietary Behaviors Questionnaire.

This study examines the validity of a Spanish-language dietary behaviors self-report questionnaire (The Latino Dietary Behaviors Questionnaire [LDBQ]) for Latinos with diabetes. The sample (n=252) was Spanish-speaking, female (77%), middle-aged (mean age 55 years), low education (56% <8th grade education), and low income (50% <$10,000 annual household income). Baseline and 12-month measures were collected as part of a randomized clinical trial. LDBQ reliability, validity, and sensitivity to change over time were evaluated using exploratory factor analysis; internal consistency analysis; and correlation analysis using baseline and change scores for LDBQ, 3-day 24-hour dietary recall nutrient mean, and clinical measures. Cronbach's αs were moderate. Four factors were identified at both time points. Significant baseline correlations (r) were found for LDBQ total scores; factor scores; and energy intake (r=-0.29 to -0.34), total dietary fiber (r=0.19), sodium (r=-0.24 to -0.30), percent energy from total fat (r=-0.16), fat subtypes (r=-0.16 to 0.15), and percent energy from protein (r=0.17). Twelve-month data produced a similar pattern. T tests of LDBQ change scores showed significantly greater change in dietary behaviors for the intervention group than for the control group, t(135)=-4.17, P<0.01. LDBQ change scores correlated significantly with mean 24-hour nutrient intake and a subset of clinical measures, but were not associated with clinical change scores (except high-density lipoprotein cholesterol). The LDBQ is a useful tool to assess and target behaviors for change and assess intervention effects.

Counseling African Americans to Control Hypertension (CAATCH) trial: a multi-level intervention to improve blood pressure control in hypertensive blacks.

Despite strong evidence of effective interventions targeted at blood pressure (BP) control, there is little evidence on the translation of these approaches to routine clinical practice in care of hypertensive blacks. The goal of this study is to evaluate the effectiveness of a multilevel, multicomponent, evidence-based intervention compared with usual care in improving BP control among hypertensive blacks who receive care in community health centers. The primary outcomes are BP control rate at 12 months and maintenance of intervention 1 year after the trial. The secondary outcomes are within-patient change in BP from baseline to 12 months and cost-effectiveness of the intervention. Counseling African Americans to Control Hypertension (CAATCH) is a group randomized clinical trial with 2 conditions: intervention condition and usual care. Thirty community health centers were randomly assigned equally to the intervention condition group (n=15) or the usual care group (n=15). The intervention comprises 3 components targeted at patients (interactive computerized hypertension education, home BP monitoring, and monthly behavioral counseling on lifestyle modification) and 2 components targeted at physicians (monthly case rounds based on Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure guidelines, chart audit and provision of feedback on clinical performance and patients' home BP readings). All outcomes are assessed at quarterly study visits for 1 year. Chart review is conducted at 24 months to evaluate maintenance of intervention effects and sustainability of the intervention. Poor BP control is one of the major reasons for the mortality gap between blacks and whites. Findings from this study, if successful, will provide salient information needed for translation and dissemination of evidence-based interventions targeted at BP control into clinical practice for this high-risk population.

Provider communication effects medication adherence in hypertensive African Americans.

OBJECTIVE: To evaluate the effect of patients' perceptions of providers' communication on medication adherence in hypertensive African Americans. METHODS: Cross-sectional study of 439 patients with poorly controlled hypertension followed in community-based healthcare practices in the New York metropolitan area. Patients' rating of their providers' communication was assessed with a perceived communication style questionnaire,while medication adherence was assessed with the Morisky self-report measure. RESULTS: Majority of participants were female, low-income, and had high school level educations, with mean age of 58 years. Fifty-five percent reported being nonadherent with their medications; and 51% rated their provider's communication to be non-collaborative. In multivariate analysis adjusted for patient demographics and covariates (depressive symptoms, provider degree), communication rated as collaborative was associated with better medication adherence (beta=-.11, p=.03). Other significant correlates of medication adherence independent of perceived communication were age (beta=.13, p=.02) and depressive symptoms (beta=-.18, p=.001). CONCLUSION: Provider communication rated as more collaborative was associated with better adherence to antihypertensive medications in a sample of low-income hypertensive African-American patients. PRACTICE IMPLICATIONS: The quality of patient-provider communication is a potentially modifiable element of the medical relationship that may affect health outcomes in this high-risk patient population.

Revision and validation of the medication adherence self-efficacy scale (MASES) in hypertensive African Americans.

Study purpose was to revise and examine the validity of the Medication Adherence Self-Efficacy Scale (MASES) in an independent sample of 168 hypertensive African Americans: mean age 54 years (SD = 12.36); 86% female; 76% high school education or greater. Participants provided demographic information; completed the MASES, self-report and electronic measures of medication adherence at baseline and three months. Confirmatory (CFA), exploratory (EFA) factor analyses, and classical test theory (CTT) analyses suggested that MASES is unidimensional and internally reliable. Item response theory (IRT) analyses led to a revised 13-item version of the scale: MASES-R. EFA, CTT, and IRT results provide a foundation of support for MASES-R reliability and validity for African Americans with hypertension. Research examining MASES-R psychometric properties in other ethnic groups will improve generalizability of findings and utility of the scale across groups. The MASES-R is brief, quick to administer, and can capture useful data on adherence self-efficacy.

A senior center-based pilot trial of the effect of lifestyle intervention on blood pressure in minority elderly people with hypertension.

OBJECTIVES: To test the feasibility, acceptability, and effect of a senior center-based behavioral counseling lifestyle intervention on systolic blood pressure (BP). DESIGN: A pre-post design pilot trial of behavioral counseling for therapeutic lifestyle changes in minority elderly people with hypertension. Participants completed baseline visit, Visit 1 (approximately 6 weeks postbaseline), and a final study Visit 2 (approximately 14 weeks postbaseline) within 4 months. SETTING: The study took place in six community-based senior centers in New York City with 65 seniors (mean age 72.29+/-6.92; 53.8% female; 84.6% African American). PARTICIPANTS: Sixty-five minority elderly people. INTERVENTION: Six weekly and two monthly "booster" group sessions on lifestyle changes to improve BP (e.g., diet, exercise, adherence to prescribed antihypertensive medications). MEASUREMENTS: Primary outcome was systolic BP (SBP) measured using an automated BP monitor. Secondary outcomes were diastolic BP (DBP), physical activity, diet, and adherence to prescribed antihypertensive medications. RESULTS: There was a significant reduction in average SBP of 13.0+/-21.1 mmHg for the intervention group (t(25)=3.14, P=.004) and a nonsignificant reduction in mean SBP of 10.6+/-30.0 mmHg for the waitlist control group (t(29)=1.95, P=.06). For the intervention group, adherence improved 26% (t(23)=2.31, P=.03), and vegetable intake improved 23% (t(25)=2.29, P=.03). CONCLUSION: This senior center-based lifestyle intervention was associated with a significant reduction in SBP and adherence to prescribed antihypertensive medications and diet in the intervention group. Participant retention and group attendance rates suggest that implementing a group-counseling intervention in senior centers is feasible.

Appointment-keeping behavior is not related to medication adherence in hypertensive African Americans.

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.

Factor structure of the Bulimia Test--Revised in college women from four ethnic groups.

The factor structure of the Bulimia Test--Revised (BULIT-R) was investigated using confirmatory factor analysis (CFA) and exploratory factor analysis (EFA). The sample consisted of 2,671 female college students (African American, Asian American, Caucasian American, and Latino American). Reliability coefficients were excellent across groups. African Americans scored significantly lower on the BULIT-R than Caucasian Americans. Across groups, CFA and EFA results suggest a six-factor solution is most appropriate. Consistent across groups were factors representing bingeing, body image, purging, and extreme weight loss behaviors, while few differences were observed across groups. These findings suggest that the measure is reliable and valid for use with diverse ethnic groups. Future research should focus on culturally salient psychological correlates of disordered eating in diverse ethnic groups.

The scale of ethnic experience: development and psychometric properties.

The Scale of Ethnic Experience (SEE) is a new self-report instrument designed to measure multiple ethnicity-related cognitive constructs across ethnic groups. We present the development and psychometric properties here. We generated and refined an item pool using expert consultants and culturally diverse focus groups. We derived a final 32-item version of the SEE based on separate factor analyses of data from college students in 4 ethnic groups: African Americans, Caucasian Americans, Filipino Americans, and Mexican Americans. Four factors were consistent across the ethnic groups: Ethnic Identity, Perceived Discrimination, Mainstream Comfort, and Social Affiliation. We found evidence of test-retest reliability, internal consistency, and criterion and construct validity for all groups. Finally, we cross-validated the factor structure of the SEE in a culturally diverse sample. Results support the reliability and validity of the SEE as a multidimensional measure of ethnicity-related cognitive constructs that can be used across American ethnic groups.

Conceptualizing and measuring ethnic discrimination in health research.

This paper presents the General Ethnic Discrimination Scale, an 18-item measure of perceived ethnic discrimination that can be used in health research with any ethnic group. The 1569 participants (half college students, half community adults) completed the General Ethnic Discrimination scale and measures of cigarette smoking and of psychiatric symptoms. Results revealed that the General Ethnic Discrimination subscales model the latent construct of perceived ethnic discrimination equally well for Blacks, Latinos, Asians, and Whites. Discrimination was strongly related to psychiatric symptoms and to current cigarette smoking for ethnic minorities and Whites alike, but such relationships were stronger for ethnic minorities. Minorities who experienced frequent discrimination were 2.3 times more likely than their low-discrimination counterparts to be smokers. This 5th grade reading-level scale takes 10 min to complete and has sufficient, initial psychometric integrity for use in clinical and community health studies.

Factorial validity of the multidimensional health locus of control scales for three American ethnic groups.

This study examined the psychometric properties (specifically, the factorial invariance) of the Multidimensional Health Locus of Control scales in a multicultural sample of college students. The original 18-item MHLC was administered, along with measures of ethnicity-related variables, to 1845 college students from three ethnic groups (Caucasian Americans, Filipino Americans and Latino Americans). Confirmatory factor analysis failed to confirm a three-factor structure for any of the three groups. Subsequent exploratory principal components analysis supported a cross-ethnic-group three-factor structure that had reduced numbers of items loading adequately on each factor. Shortened scales were created, and internal consistency reliability for each scale was acceptable for each ethnic group. Filipino Americans scored higher on all three scales. Regression analyses predicting MHLC scales from demographic and sociocultural variables revealed few predictive relationships.

Cigarette advertising in magazines for Latinas, White women, and men, 1998--2002: a preliminary investigation.

Cigarette ads in popular magazines play a role in smoking and in brand preferences among women and men, but few studies have analyzed ads directed at women vs men, and no study has examined ads directed at women of different ethnic groups. Hence, we examined cigarette ads in popular magazines for White women, Latinas, and men 1998 through 2002 for the first time. Significant differences in the number of cigarette ads by magazine audience were found, along with significant differences in the type and brands of cigarettes advertised to each group. These preliminary findings suggest that the tobacco industry may target women in a manner that differs from its targeting of men, and may target Latinas in a manner that it does not target White women. Results are discussed in terms of the need for further research on tobacco ads directed at women.

Cigarette advertising in Black, Latino, and White magazines, 1998-2002: an exploratory investigation.

OBJECTIVE: To examine the number, type (menthol vs non-menthol), brand (Black, White, Women's, Other), and size of cigarette ads in Black, Latino, and White magazines. METHOD: Analysis of digital photographs of 274 cigarette ads appearing in Ebony (Black), People (White), and People in Spanish (Latino) for the 4.5-year period of January 1998 to August 2002. RESULTS: Black magazines were 9.8 times and Latino magazines 2.6 times more likely than White magazines to contain ads for menthol cigarettes. Black and Latino magazines also contained significantly more ads for brands (Virginia Slims) that target women. CONCLUSIONS: The tobacco industry continues to target Blacks with menthol cigarette ads, appears now to be targeting Latinos similarly, and targets Black and Latino women with additional, tailored cigarette ads.

Preliminary investigation of the advertising and availability of PREPs, the new "safe" tobacco products.

The tobacco industry recently introduced a new set of "safe" cigarettes and nicotine delivery devices that purportedly entail reduced tobacco-related disease risk due to their lower level of some carcinogens and toxins. Little is know about the biological impact of these potential reduced exposure products (PREPs) and nothing is known about their advertising and availability. Hence, two pilot studies were conducted to examine the latter issues for the first time. In Study 1, we examined tobacco ads in 10 popular magazines 1998--2002 and found that only 1% of ads were for PREPs. In Study 2, we attempted to purchase PREPs in a random sample of 113 small stores and found that only 4.4% sold any PREP. These preliminary findings tentatively suggest that the industry might not yet be heavily invested in products that have the potential to increase tobacco use by decreasing its perceived harm. Studies with larger samples are recommended.