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2.  THE LATINO HEALTH PROJECT: PILOT TESTING A CULTURALLY ADAPTED BEHAVIORAL WEIGHT LOSS INTERVENTION IN OBESE AND OVERWEIGHT LATINO ADULTS 
Ethnicity & Disease  2012;22(1):51-57.
Objective
To pilot test a culturally adapted behavioral weight loss intervention in obese and overweight Latino adults.
Design
Pilot study.
Setting
Latino community organization in Durham, North Carolina.
Participants
Overweight and obese, self-identified Latinos ≥18 years old.
Intervention
Intervention consisted of 20 weekly group sessions (90–120 minutes each) incorporating motivational interviewing techniques. The intervention goal was weight loss by adopting the Dietary Approach to Stop Hypertension (DASH) dietary pattern, increasing physical activity, and reducing caloric intake. The cultural adaptation included foods and physical activities commonly used in the Latino culture, using a Spanish-speaking interventionist, and conducting the intervention at a local Latino community organization.
Main outcome measures
Weight, body mass index (BMI), blood pressure, dietary pattern, and physical activity were measured at baseline and at 20 weeks.
Results
A total of 56 participants are included in the final analysis. The average weight loss was 5.1 lbs (95% CI −8.7 to −1.5; P=.006); and there was a reduction in BMI of 1.3 kg/m2 (95% CI −2.2 to −0.5; P=.002) at 20 weeks. Systolic blood pressure decreased by 2.6 mm Hg (95% CI −4.7 to −0.6; P=.013).
Conclusion
A culturally adapted behavioral intervention for the treatment of overweight and obesity is potentially effective in a diverse group of Latino adults.
PMCID: PMC3395222  PMID: 22774309
Obesity; Overweight; Latinos; Cultural; Intervention; Weight Loss
3.  Racial Differences in Two Self Management Hypertension Interventions 
The American journal of medicine  2011;124(5):468.e1-468.e8.
Background
Only one-half of Americans have their blood pressure controlled and there continue to be significant racial differences in blood pressure control. The goal of this study was to examine the effectiveness of two patient-directed interventions designed to improve blood pressure control within white and non-white subgroups (49% African Americans).
Methods
Post-hoc analysis of a 2 by 2 randomized trial with two-year follow-up in 2 university-affiliated primary care clinics. Within white and non-white patients (n=634), four groups were examined: 1) usual care; 2) home blood pressure monitoring (three times per week); 3) tailored behavioral self-management intervention administered via telephone by a nurse every other month; or, 4) a combination of the two interventions.
Results
The overall race by time by treatment group effect suggested differential intervention effects on blood pressure over time for whites and non-whites (systolic blood pressure, p=0.08; diastolic blood pressure, p=0.01). Estimated trajectories indicated that among the 308 whites, there was no significant effect on blood pressure at either 12 or 24 months for any intervention compared to control group. At 12 months, the non-whites (n=328) in all three intervention groups had systolic blood pressure decreases of 5.3–5.7 mm hg compared to usual care (p<0.05). At 24 months, in the combined intervention, non-whites had sustained lower systolic blood pressure as compared to usual care (7.5 mm hg; p<0.02). A similar pattern was observed for diastolic blood pressure.
Conclusion
Combined home blood pressure monitoring and a telephone tailored-behavioral intervention appeared to be particularly effective for improving blood pressure in non-white patients.
doi:10.1016/j.amjmed.2010.11.024
PMCID: PMC3086723  PMID: 21531237
Hypertension; Lifestyle; Clinical Trial; Self-management; Adherence; Disparities
4.  Patient and provider interventions for managing osteoarthritis in primary care: protocols for two randomized controlled trials 
Background
Osteoarthritis (OA) of the hip and knee are among the most common chronic conditions, resulting in substantial pain and functional limitations. Adequate management of OA requires a combination of medical and behavioral strategies. However, some recommended therapies are under-utilized in clinical settings, and the majority of patients with hip and knee OA are overweight and physically inactive. Consequently, interventions at the provider-level and patient-level both have potential for improving outcomes. This manuscript describes two ongoing randomized clinical trials being conducted in two different health care systems, examining patient-based and provider-based interventions for managing hip and knee OA in primary care.
Methods / Design
One study is being conducted within the Department of Veterans Affairs (VA) health care system and will compare a Combined Patient and Provider intervention relative to usual care among n = 300 patients (10 from each of 30 primary care providers). Another study is being conducted within the Duke Primary Care Research Consortium and will compare Patient Only, Provider Only, and Combined (Patient + Provider) interventions relative to usual care among n = 560 patients across 10 clinics. Participants in these studies have clinical and / or radiographic evidence of hip or knee osteoarthritis, are overweight, and do not meet current physical activity guidelines. The 12-month, telephone-based patient intervention focuses on physical activity, weight management, and cognitive behavioral pain management. The provider intervention involves provision of patient-specific recommendations for care (e.g., referral to physical therapy, knee brace, joint injection), based on evidence-based guidelines. Outcomes are collected at baseline, 6-months, and 12-months. The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (self-reported pain, stiffness, and function), and secondary outcomes are the Short Physical Performance Test Protocol (objective physical function) and the Patient Health Questionnaire-8 (depressive symptoms). Cost effectiveness of the interventions will also be assessed.
Discussion
Results of these two studies will further our understanding of the most effective strategies for improving hip and knee OA outcomes in primary care settings.
Trial registration
NCT01130740 (VA); NCT 01435109 (NIH)
doi:10.1186/1471-2474-13-60
PMCID: PMC3433311  PMID: 22530979
Osteoarthritis; Physical activity; Weight reduction program; Pain management; Intervention study
5.  Participant Evaluation of a Telephone-Based Osteoarthritis Self-Management Program, 2006-2009 
Introduction
Self-management support interventions can help improve osteoarthritis outcomes but are underused. Little is known about how participants evaluate the helpfulness of these programs. We describe participants' evaluations of a telephone-based, osteoarthritis self-management support intervention that yielded improved outcomes in a clinical trial.
Methods
Participants were 140 people in the intervention arm of the trial who completed an end-of-trial survey. We used mixed methods to describe participants' perceived helpfulness of the program and its components. We compared ratings of helpfulness according to participant characteristics and analyzed themes from open-ended responses with a constant comparison approach. We calculated Pearson correlation coefficients between perceived helpfulness and changes in pain, function, affect, and self-efficacy.
Results
The average rating of overall helpfulness on a scale from 1 to 10 was 7.6 (standard deviation, 2.3), and more than 80% of participants agreed that each component (phone calls, educational material, setting goals and action plans) was helpful. Participants had better perceived helpfulness ratings than their counterparts if they were nonwhite, had limited health literacy, had no college education, had perceived inadequate income, were older, had a spouse or were living together in a committed relationship, and had greater symptom duration and less pain. Ratings of helpfulness increased with greater improvement in outcomes. Participants frequently mentioned the health educator's calls as being helpful for staying on task with self-management behaviors.
Conclusion
Participants viewed this intervention and each of its components as helpful for improving osteoarthritis symptoms. In addition to the improvements in objective outcomes seen in the clinical trial, these results provide further support for the dissemination of self-management support interventions.
PMCID: PMC3392090  PMID: 22440547
6.  A Re-conceptualization of Access for 21st Century Healthcare 
Journal of General Internal Medicine  2011;26(Suppl 2):639-647.
Many e-health technologies are available to promote virtual patient–provider communication outside the context of face-to-face clinical encounters. Current digital communication modalities include cell phones, smartphones, interactive voice response, text messages, e-mails, clinic-based interactive video, home-based web-cams, mobile smartphone two-way cameras, personal monitoring devices, kiosks, dashboards, personal health records, web-based portals, social networking sites, secure chat rooms, and on-line forums. Improvements in digital access could drastically diminish the geographical, temporal, and cultural access problems faced by many patients. Conversely, a growing digital divide could create greater access disparities for some populations. As the paradigm of healthcare delivery evolves towards greater reliance on non-encounter-based digital communications between patients and their care teams, it is critical that our theoretical conceptualization of access undergoes a concurrent paradigm shift to make it more relevant for the digital age. The traditional conceptualizations and indicators of access are not well adapted to measure access to health services that are delivered digitally outside the context of face-to-face encounters with providers. This paper provides an overview of digital “encounterless” utilization, discusses the weaknesses of traditional conceptual frameworks of access, presents a new access framework, provides recommendations for how to measure access in the new framework, and discusses future directions for research on access.
doi:10.1007/s11606-011-1806-6
PMCID: PMC3191218  PMID: 21989616
access; e-health; digital; connectivity; veterans
7.  Individual Progress Toward Self-Selected Goals Among Older Adults Enrolled in a Physical Activity Counseling Intervention 
The purpose of this study was to examine what happens to goals over the course of a physical activity counseling trial in older veterans. At baseline, participants (N = 313) identified 1 health-related goal and 1 walking goal for their participation in the study and rated where they perceived themselves to be relative to that goal at the current time. They rated their current status on these same goals again at 6 and 12 mo. Growth-curve analyses were used to examine longitudinal change in perceived goal status. Although both the intervention and control groups demonstrated improvement in their perceived proximity to their health-related and walking goals (L = 1.19, p < .001), the rates of change were significantly greater in the intervention group (β = −.30, p < .05). Our results demonstrate that this physical activity counseling intervention had a positive impact on self-selected goals over the course of the intervention.
PMCID: PMC3108332  PMID: 20956844
goal setting; longitudinal; function; exercise behavior
8.  Hypertension Improvement Project (HIP) Latino: results of a pilot study of lifestyle intervention for lowering blood pressure in Latino adults 
Ethnicity & health  2010;15(3):269-282.
Objectives
To assess the feasibility of a culturally tailored behavioral intervention for improving hypertension-related health behaviors in Hispanic/Latino adults.
Design
Feasibility pilot study in a community health center and a Latino organization in Durham, North Carolina (NC).
Intervention
The culturally adapted behavioral intervention consisted of 6 weekly group sessions incorporating motivational interviewing techniques. Goals included weight loss if overweight, adoption of the Dietary Approaches to Stop Hypertension (DASH) dietary pattern, and increased physical activity. Participants were also encouraged to monitor their daily intake of fruits, vegetables, dairy and fat, and to record physical activity. Cultural adaptations included conducting the study in familiar places, using Spanish-speaking interventionist, culturally-appropriate food choices, and physical activity.
Main outcomes
Systolic blood pressure, weight, body mass index (BMI), exercise, and dietary pattern were measured at baseline and at 6 weeks follow-up. Qualitative evaluations of the recruitment process and the intervention were also conducted.
Results
There were 64 potential participants identified via health care provider referrals (33%), printed media (23%), and direct contact (44%). Seventeen participants completed the intervention and had main outcome data available. Participants “strongly agreed/ agreed” that the group sessions provided them with the tools they needed to achieve weight loss, blood pressure control, and the possibility of sustaining the lifestyle changes after completing the intervention. At the end of the intervention, all physiological, diet, and exercise outcomes were more favorable, with the exception of fat. After 6 weeks, systolic blood pressure decreased an average of −10.4 ± 10.6 mmHg, weight decreased 1.5 ± 3.2 lbs, BMI decreased 0.3 ± 0.5, and physical activity increased 40 minutes per week.
Conclusion
Our findings suggest that lifestyle interventions for preventing and treating hypertension are feasible and potentially effective in the Hispanic/Latino population.
doi:10.1080/13557851003674997
PMCID: PMC2888677  PMID: 20379894
Hypertension; Hispanic; Latino; non pharmacologic interventions; blood pressure control; weight loss; DASH dietary pattern; lifestyle intervention
9.  The impact of self-reported arthritis and diabetes on response to a home-based physical activity counseling intervention 
Objectives
Physical activity (PA) has potential to improve outcomes in both arthritis and diabetes, but these conditions are rarely examined together. Our objective was to explore whether persons with arthritis alone or those with both arthritis and diabetes could improve amounts of PA with a home-based counseling intervention.
Methods
As part of the Veterans LIFE Study, veterans ages 70–92 were randomized to usual care or a twelve month PA counseling program. Arthritis and diabetes were assessed via self-report. Mixed models were used to compare trajectories for minutes of endurance and strength training PA for persons with no arthritis (n=85), arthritis (n=178), and arthritis plus diabetes (n=84).
Results
Recipients of PA counseling increased minutes of PA per week independent of disease status (treatment arm by time interaction P<0.05 for both; endurance training time P=0.0006 and strength training time P<0.0001). Although PA was lower at each wave among persons with arthritis, and even more so among persons with arthritis plus diabetes, the presence of these conditions did not significantly influence response to the intervention (Arthritis/Diabetes group X time interactions P>0.05 for both outcomes) as each group experienced a nearly two-fold or more increase in PA.
Conclusions
A home-based PA intervention was effective in increasing minutes of weekly moderate intensity endurance and strength training PA in older veterans, even among those with arthritis or arthritis plus diabetes. This program may serve as a useful model to improve outcomes in older persons with these pervasive diseases.
doi:10.3109/03009740903348973
PMCID: PMC2963864  PMID: 20429674
Physical Activity; Arthritis; Diabetes; Counseling
10.  Does Diabetes Associate with Poorer Self-Efficacy and Motivation for Physical Activity in Older Adults with Arthritis? 
Objectives
To explore 1) Whether arthritis associates with poorer self-efficacy and motivation for, and participation in, two specific types of physical activity (PA): Endurance training (ET) and strength training (ST), and 2) If the added burden of diabetes contributes to a further reduction in these PA determinants and types.
Methods
Self-efficacy and motivation for exercise and minutes per week of ET and ST were measured in 347 older Veterans enrolled in a home-based PA counseling intervention. Regression analyses were used to compare high versus low self-efficacy and motivation and PA minutes in persons without arthritis, with arthritis alone, and with arthritis plus diabetes.
Results
Persons with arthritis alone reported lower self-efficacy for ET and ST than those without arthritis (Odds ratio[OR]ET 0.71 (0.39,1.20); ORST 0.69 (0.39,1.20)). A further reduction in self-efficacy for these two types of PA was observed for those with both arthritis and diabetes (ORET 0.65 (0.44,0.92); ORST 0.64 (0.44,0.93); trend P<0.001). There was no trend towards a reduction in motivation for PA in those with arthritis alone or arthritis and diabetes. Persons with arthritis exhibited higher motivation for ET than those without arthritis (ORET 1.85 (1.12,3.33). There were no significant differences between the three groups in minutes of ET (P=0.93), but persons with arthritis plus diabetes reported significantly less ST compared to individuals with arthritis only (P=0.03).
Conclusions
Despite reduced self-efficacy for ET and ST and less ST in older persons with arthritis, motivation for both PA types remains high, even in the presence of diabetes.
doi:10.3109/03009741003605630
PMCID: PMC3058748  PMID: 20604671
exercise self-efficacy; co-morbidity; strength training
11.  Long-Term Changes in Physical Activity Following a One-Year Home-Based Physical Activity Counseling Program in Older Adults with Multiple Morbidities 
Journal of Aging Research  2010;2011:308407.
This study assessed the sustained effect of a physical activity (PA) counseling intervention on PA one year after intervention, predictors of sustained PA participation, and three classes of post-intervention PA trajectories (improvers, maintainers, and decliners) in 238 older Veterans. Declines in minutes of PA from 12 to 24 months were observed for both the treatment and control arms of the study. PA at 12 months was the strongest predictor of post-intervention changes in PA. To our surprise, those who took up the intervention and increased PA levels the most, had significant declines in post-intervention PA. Analysis of the three post-intervention PA trajectories demonstrated that the maintenance group actually reflected a group of nonresponders to the intervention who had more comorbidities, lower self-efficacy, and worse physical function than the improvers or decliners. Results suggest that behavioral counseling/support must be ongoing to promote maintenance. Strategies to promote PA appropriately to subgroups of individuals are needed.
doi:10.4061/2011/308407
PMCID: PMC3014677  PMID: 21234104
13.  Study protocol: The Adherence and Intensification of Medications (AIM) study - a cluster randomized controlled effectiveness study 
Trials  2010;11:95.
Background
Many patients with diabetes have poor blood pressure (BP) control. Pharmacological therapy is the cornerstone of effective BP treatment, yet there are high rates both of poor medication adherence and failure to intensify medications. Successful medication management requires an effective partnership between providers who initiate and increase doses of effective medications and patients who adhere to the regimen.
Methods
In this cluster-randomized controlled effectiveness study, primary care teams within sites were randomized to a program led by a clinical pharmacist trained in motivational interviewing-based behavioral counseling approaches and authorized to make BP medication changes or to usual care. This study involved the collection of data during a 14-month intervention period in three Department of Veterans Affairs facilities and two Kaiser Permanente Northern California facilities. The clinical pharmacist was supported by clinical information systems that enabled proactive identification of, and outreach to, eligible patients identified on the basis of poor BP control and either medication refill gaps or lack of recent medication intensification. The primary outcome is the relative change in systolic blood pressure (SBP) measurements over time. Secondary outcomes are changes in Hemoglobin A1c, low-density lipoprotein cholesterol (LDL), medication adherence determined from pharmacy refill data, and medication intensification rates.
Discussion
Integration of the three intervention elements - proactive identification, adherence counseling and medication intensification - is essential to achieve optimal levels of control for high-risk patients. Testing the effectiveness of this intervention at the team level allows us to study the program as it would typically be implemented within a clinic setting, including how it integrates with other elements of care.
Trial Registration
The ClinicalTrials.gov registration number is NCT00495794.
doi:10.1186/1745-6215-11-95
PMCID: PMC2967508  PMID: 20939913
14.  The moderating role of personality factors in the relationship between depression and neuropsychological functioning among older adults 
SUMMARY
Objective
Depression is often associated with decreased cognitive performance among older adults. The current study focused on the association of neuropsychological functioning and personality traits in depressed and non-depressed older adults.
Methods
Data from 75 depressed and 103 non-depressed adults over the age of 60 were analyzed. All participants underwent standardized clinical assessment for depression prior to participation and completed the NEO-PI-R and a series of neuropsychological assessments.
Results
A series of multiple linear regressions were conducted to examine the relationships between personality and neuropsychological performance among depressed and non-depressed older adults. Results indicated that higher Openness to Experience was related to better performance on Parts A and B of the Trail Making Test among depressed older adults, and to better Digit Span Backward performance among all participants. Higher levels of neuroticism were related to poorer performance on Digit Span Backward, but only among depressed older adults. Depressed participants performed more poorly on the Symbol Digit Modalities Test and the Controlled Oral Word Association Test.
Conclusions
Personality characteristics, particularly Openness to Experience, modified the relationship between depression and neuropsychological functioning among older adults. Results indicate that interventions aimed at increasing one’s Openness to Experience could potentially attenuate some of the neuropsychological impairments that are associated with depression.
doi:10.1002/gps.2213
PMCID: PMC2730210  PMID: 19226526
depression; personality; neurocognitive function
15.  Economic Evaluation of Home Blood Pressure Monitoring With or Without Telephonic Behavioral Self-Management in Patients With Hypertension 
American journal of hypertension  2009;23(2):142-148.
Background
The Take Control of Your Blood Pressure trial evaluated the effect of a multicomponent telephonic behavioral lifestyle intervention, patient self-monitoring, and both interventions combined compared with usual care on reducing systolic blood pressure during 24 months. The combined intervention led to a significant reduction in systolic blood pressure compared with usual care alone. We examined direct and patient time costs associated with each intervention.
Methods
We conducted a prospective economic evaluation alongside a randomized controlled trial of 636 patients with hypertension participating in each study intervention. Medical costs were estimated using electronic data representing medical services delivered within the health system. Intervention-related costs were derived using information collected during the trial, administrative records, and published unit costs.
Results
During 24 months, patients incurred a mean of $6965 (SD, $22,054) in inpatient costs and $8676 (SD, $9368) in outpatient costs, with no significant differences among the intervention groups. With base-case assumptions, intervention costs were estimated at $90 (SD, $2) for home blood pressure monitoring, $345 (SD, $64) for the behavioral intervention ($31 per telephone encounter), and $416 (SD, $93) for the combined intervention. Patient time costs were estimated at $585 (SD, $487) for home monitoring, $55 (SD, $16) for the behavioral intervention, and $741 (SD, $529) for the combined intervention.
Conclusions
Our analysis demonstrated that the interventions are cost-additive to the health care system in the short term and that patients’ time costs are nontrivial.
doi:10.1038/ajh.2009.215
PMCID: PMC2901769  PMID: 19927132
Costs and Cost Analysis; Hypertension; Patient Compliance
16.  Change in Goal Ratings as a Mediating Variable between Self-Efficacy and Physical Activity in Older Men 
Background
Few studies have examined the associations between exercise self-efficacy, goals, and physical activity over time.
Purpose
This study examines whether self-selected goals mediate the changes in exercise self-efficacy on physical activity over 12 months.
Methods
Data are derived from 313 older men participating in the Veterans Life Study.
Results
Changes in exercise self-efficacy were significantly associated with changes in physical activity both directly (βs = .25 and .24, p < .05) and indirectly (βs = .24 and .30, p < .05) through changes in health-related and walking goal ratings (βs = .19 and .20, p < .05). Both types of goal setting continued to partially mediate the relationship between exercise self-efficacy and physical activity when covariates were added to the models. This study extends the application of social cognitive and goal-setting theories to physical activity by showing that goals partially mediate the relationship between exercise self-efficacy and physical activity over time.
doi:10.1007/s12160-010-9177-5
PMCID: PMC2904848  PMID: 20387023
goal setting; physical activity; self-efficacy; randomized controlled trial; older adults
17.  Is there a nonadherent subtype of hypertensive patient? A latent class analysis approach 
To determine subtypes of adherence, 636 hypertensive patients (48% White, 34% male) reported adherence to medications, diet, exercise, smoking, and home blood pressure monitoring. A latent class analysis approach was used to identify subgroups that adhere to these five self-management behaviors. Fit statistics suggested two latent classes. The first class (labeled “more adherent”) included patients with greater probability of adhering to recommendations compared with the second class (labeled “less adherent”) with regard to nonsmoking (97.7% versus 76.3%), medications (75.5% versus 49.5%), diet (70.7% versus 46.9%), exercise (63.4% versus 27.2%), and blood pressure monitoring (32% versus 3.4%). Logistic regression analyses used to characterize the two classes showed that “more adherent” participants were more likely to report full-time employment, adequate income, and better emotional and physical well-being. Results suggest the presence of a less adherent subtype of hypertensive patients. Behavioral interventions designed to improve adherence might best target these at-risk patients for greater treatment efficiency.
PMCID: PMC2915558  PMID: 20694185
adherence; hypertension; latent class analysis; self-management
18.  The implementation of a translational study involving a primary care based behavioral program to improve blood pressure control: The HTN-IMPROVE study protocol (01295) 
Background
Despite the impact of hypertension and widely accepted target values for blood pressure (BP), interventions to improve BP control have had limited success.
Objectives
We describe the design of a 'translational' study that examines the implementation, impact, sustainability, and cost of an evidence-based nurse-delivered tailored behavioral self-management intervention to improve BP control as it moves from a research context to healthcare delivery. The study addresses four specific aims: assess the implementation of an evidence-based behavioral self-management intervention to improve BP levels; evaluate the clinical impact of the intervention as it is implemented; assess organizational factors associated with the sustainability of the intervention; and assess the cost of implementing and sustaining the intervention.
Methods
The project involves three geographically diverse VA intervention facilities and nine control sites. We first conduct an evaluation of barriers and facilitators for implementing the intervention at intervention sites. We examine the impact of the intervention by comparing 12-month pre/post changes in BP control between patients in intervention sites versus patients in the matched control sites. Next, we examine the sustainability of the intervention and organizational factors facilitating or hindering the sustained implementation. Finally, we examine the costs of intervention implementation. Key outcomes are acceptability and costs of the program, as well as changes in BP. Outcomes will be assessed using mixed methods (e.g., qualitative analyses--pattern matching; quantitative methods--linear mixed models).
Discussion
The study results will provide information about the challenges and costs to implement and sustain the intervention, and what clinical impact can be expected.
doi:10.1186/1748-5908-5-54
PMCID: PMC2914777  PMID: 20637095
19.  Two Self-management Interventions to Improve Hypertension Control: A Randomized Trial 
Annals of internal medicine  2009;151(10):687-695.
Background
Less than 40% of Americans with hypertension have adequate blood pressure (BP) control.
Objectives
To compare two self-management interventions for improving BP control among hypertensive patients.
Design
A 2 by 2 randomized trial stratified by enrollment site and patient literacy status with two-year follow-up (5/2004-1/2008).
Setting
Two university-affiliated primary care clinics.
Patients
636 patients were randomized (31% recruitment rate) among the 2060 eligible hypertensive patients.
Interventions
Research assistants randomized eligible patients via a centralized blinded and stratified randomization algorithm to receive either: 1) usual care; 2) bi-monthly tailored nurse-administered telephone intervention targeting hypertension-related behaviors; 3) BP monitoring consisting of measuring BP three times per week, or; 4) a combination of the two interventions.
Measurements
The primary outcome was BP control evaluated at six-month intervals over 24 months. 475 (75%) completed the 24-month BP follow-up.
Results
Improvements in proportion of BP control for the intervention groups relative to the usual care group at 24 months were: behavioral group, 4.3% (95% CI: −4.5%, 12.9); home BP monitoring group, 7.6% (95% CI: −1.9%, 17.0%); and, combined interventions, 11.0% (95% CI: 1.9%, 19.8%). For systolic BP, relative to usual care, the 24 month difference was, +0.6 mmHg (95% CI: −2.2, 3.4) for the behavioral intervention group, −0.6 mmHg (95% CI: −3.6, 2.3) for the home monitoring group, and −3.9 mmHg (95% CI: −6.9, −0.9) for the combined interventions. Similar patterns were observed for diastolic BP at 24 months.
Limitations
Changes in medication use and diet were only monitored in intervention participants; 25% lacked 24 month outcome data; 73% had adequate BP control at baseline; the study setting was an academic health center, all factors that potentially limit generalizability.
Conclusion
Combined home BP monitoring and tailored behavioral telephone intervention improved BP control, systolic BP, and diastolic BP at 24 months relative to usual care.
doi:10.1059/0003-4819-151-10-200911170-00148
PMCID: PMC2892337  PMID: 19920269
Hypertension; Lifestyle; Clinical Trial; Self-management; Adherence
20.  The Veterans LIFE Study: A Randomized Trial of Primary Care Based Physical Activity Counseling For Older Men 
BACKGROUND
Slow gait is predictive of adverse health outcomes and increased health service utilization. Physical activity counseling (PAC) may enhance mobility among elders. Primary care settings are appropriate for PAC because most older adults see their primary care physician annually. Innovative use of automated telephone messaging facilitates physician counseling.
OBJECTIVE
To determine the effects of multi-component PAC promoting physical activity (PA) guidelines on gait speed and related measures of PA and function in older veterans.
DESIGN, SETTING, AND PARTICIPANTS
Randomized controlled trial of 398 male veterans, ages 70 and over receiving primary care at the Veterans’ Affairs Medical Center of Durham, N.C.
INTERVENTION
Twelve months of usual care (UC) or multi-component PAC consisting of baseline in-person and biweekly then monthly telephone counseling by a lifestyle counselor, one-time clinical endorsement of PA and monthly automated telephone messaging by primary care provider, and quarterly tailored mailings of progress in PA.
MEASUREMENTS
Gait speed (usual and rapid), self-reported PA, function and disability at baseline, 3, 6 and 12 months.
RESULTS
Although no between-group differences were noted for usual gait speed, rapid gait speed improved significantly more for the PAC group (1.56 (0.41) m/s to 1.68 (0.44) m/s) compared to UC (1.57 (0.40) m/sec to 1.59 (0.42) m/sec, p = 0.04). Minutes of moderate/vigorous PA increased significantly in the PAC group (from a mean (SD) 57.1 (99.3) min/wk to 126.6 (142.9) min/week) compared to the UC group (from 60.2 (116.1) to 69.6 (116.1) min/wk, p < 0.001). Changes in other functional/disability outcomes were small.
CONCLUSIONS
In this group of older male veterans, multi-component PA significantly improved rapid gait and PA. Translation from increased PA to overall functioning was not observed. Integration with primary care was successful.
doi:10.1111/j.1532-5415.2009.02301.x
PMCID: PMC2757328  PMID: 19467149
aging; counseling; health promotion; physical activity; primary care; mobility limitation; veterans; randomized clinical trial
21.  Strategies for Implementing and Sustaining Therapeutic Lifestyle Changes as Part of Hypertension Management in African Americans 
Postgraduate medicine  2009;121(3):147-159.
African Americans with high blood pressure (BP) can benefit greatly from therapeutic lifestyle changes (TLC) such as diet modification, physical activity, and weight management. However, they and their health care providers face many barriers in modifying health behaviors. A multidisciplinary panel synthesized the scientific data on TLC in African Americans for efficacy in improving BP control, barriers to behavioral change, and strategies to overcome those barriers. Therapeutic lifestyle change interventions should emphasize patient self-management, supported by providers, family, and the community. Interventions should be tailored to an individual’s cultural heritage, beliefs, and behavioral norms. Simultaneously targeting multiple factors that impede BP control will maximize the likelihood of success. The panel cited limited progress with integrating the Dietary Approaches to Stop Hypertension (DASH) eating plan into the African American diet as an example of the need for more strategically developed interventions. Culturally sensitive instruments to assess impact will help guide improved provision of TLC in special populations. The challenge of improving BP control in African Americans and delivery of hypertension care requires changes at the health system and public policy levels. At the patient level, culturally sensitive interventions that apply the strategies described and optimize community involvement will advance TLC in African Americans with high BP.
doi:10.3810/pgm.2009.05.2015
PMCID: PMC2790525  PMID: 19491553
hypertension; African Americans; therapeutic lifestyle change; behavioral modification; cultural competence; diet
22.  Content validity in the PROMIS social health domain: a qualitative analysis of focus group data 
Purpose
Our aim was to assess the content validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) social health item banks by comparing a prespecified conceptual model with concepts that focus-group participants identified as important social-health-related outcomes. These data will inform the process of improving health-related quality-of-life measures.
Methods
Twenty-five patients with a range of social limitations due to chronic health conditions were recruited at two sites; four focus groups were conducted. Raters independently classified participants' statements using a hierarchical, nested schema that included health-related outcomes, role performance, role satisfaction, family/friends, work, and leisure.
Results
Key themes that emerged were fulfilling both family and work responsibilities and the distinction between activities done out of responsibility versus enjoyment. Although focus-group participants identified volunteerism and pet ownership as important social-health-related concepts, these were not in our original conceptual model. The concept of satisfaction was often found to overlap with the concept of performance.
Conclusion
Our conceptual model appeared mostly comprehensive but is being further refined to more appropriately (a) distinguish between responsibilities versus discretionary activities, and (b) situate the outcome of satisfaction as it relates to impairment in social and other domains of health.
doi:10.1007/s11136-008-9352-3
PMCID: PMC2757448  PMID: 18478368
23.  Racial Differences in Blood Pressure Control: Potential Explanatory Factors 
Summary
Objective
The objective of the study was to identify potential explanatory factors for racial differences in blood pressure (BP) control.
Design
The design of the study was a cross-sectional study
Patients/Participants
The study included 608 patients with hypertension who were either African American (50%) or white (50%) and who received primary care in Durham, NC.
Measurements and Main Results
Baseline data were obtained from the Take Control of Your Blood pressure study and included clinical, demographic, and psychosocial variables potentially related to clinic BP measures. African Americans were more likely than whites to have inadequate baseline clinic BP control as defined as greater than or equal to 140/90 mmHg (49% versus 34%; unadjusted odds ratio [OR] 1.8; 95% confidence interval [CI] 1.3–2.5). Among factors that may explain this disparity, being older, reporting hypertension medication nonadherence, reporting a hypertension diagnosis for more than 5 years, reporting high levels of stress, being worried about hypertension, and reporting an increased number of medication side effects were related to inadequate BP control. In adjusted analyses, African Americans continue to have poor BP control relative to whites; the magnitude of the association was reduced (OR = 1.5; 95% CI 1.0–2.1). Medication nonadherence, worries about hypertension, and older age (>70) continued to be related to poor BP control.
Conclusions
In this sample of hypertensive patients, there were a number of factors associated with poor BP control that partially explained the observed racial disparity in hypertension control including age, medication nonadherence, and worry about BP. Medication nonadherence is of particular interest because it is a potentially modifiable factor that might be used to reduce the racial disparity in BP control.
doi:10.1007/s11606-008-0547-7
PMCID: PMC2324164  PMID: 18288540
racial disparity; hypertension; adherence; psychosocial
24.  Take Control of Your Blood pressure (TCYB) study: A multifactorial tailored behavioral and educational intervention for achieving blood pressure control 
Patient education and counseling  2007;70(3):338-347.
Objectives
Evaluating a randomized controlled trial involving a tailored behavioral intervention conducted to improve blood pressure control.
Methods
Adults with hypertension from two outpatient primary care clinics were randomly allocated to receive a nurse-administered behavioral intervention or usual care. In this ongoing study, patients receive the tailored behavioral intervention bi-monthly for two years via telephone; the goal of the intervention is to promote medication adherence and improve hypertension-related health behaviors. Patient factors targeted in the tailored behavioral intervention include perceived risk of hypertension and knowledge, memory, medical and social support, patients' relationship with their health care provider, adverse effects of medication therapy, weight management, exercise, diet, stress, smoking, and alcohol use.
Results
The sample randomized to the behavioral intervention consisted of 319 adults with hypertension (average age = 60.5 years; 47% African-American). A comparable sample of adults was assigned to usual care (n=317). We had a 96% retention rate for the overall sample for the first 6 months of the study (93% at 12 months). The average phone call has lasted 18 minutes (range 2 to 51 minutes). From baseline to six months, self-reported medication adherence increased by 9% in the behavioral group vs. 1% in the non-behavioral group.
Conclusion
The intervention is easily implemented and is designed to enhance adherence with prescribed hypertension regimen. The study includes both general and patient-tailored information based upon need assessment. The study design ensures internal validity as well as the ability to generalize study findings to the clinic settings.
Practice Implications
Despite knowledge of the risks and acceptable evidence, a large number of hypertensive adults still do not have their blood pressure under effective control. This study will be an important step in evaluating a tailored multibehavioral intervention focusing on improving blood pressure control.
doi:10.1016/j.pec.2007.11.014
PMCID: PMC2276731  PMID: 18164894
Behavioral Intervention; hypertension; adherence; tailored; health communication
25.  Literacy and blood pressure – do healthcare systems influence this relationship? A cross-sectional study 
Background
Limited literacy is common among patients with chronic conditions and is associated with poor health outcomes. We sought to determine the association between literacy and blood pressure in primary care patients with hypertension and to determine if this relationship was consistent across distinct systems of healthcare delivery.
Methods
We conducted a cross-sectional study of 1224 patients with hypertension utilizing baseline data from two separate, but similar randomized controlled trials. Patients were enrolled from primary care clinics in the Veterans Affairs healthcare system (VAHS) and a university healthcare system (UHS) in Durham, North Carolina. We compared the association between literacy and the primary outcome systolic blood pressure (SBP) and secondary outcomes of diastolic blood pressure (DBP) and blood pressure (BP) control across the two different healthcare systems.
Results
Patients who read below a 9th grade level comprised 38.4% of patients in the VAHS and 27.5% of the patients in the UHS. There was a significant interaction between literacy and healthcare system for SBP. In adjusted analyses, SBP for patients with limited literacy was 1.2 mmHg lower than patients with adequate literacy in the VAHS (95% CI, -4.8 to 2.3), but 6.1 mmHg higher than patients with adequate literacy in the UHS (95% CI, 2.1 to 10.1); (p = 0.003 for test of interaction). This literacy by healthcare system interaction was not statistically significant for DBP or BP control.
Conclusion
The relationship between patient literacy and systolic blood pressure varied significantly across different models of healthcare delivery. The attributes of the healthcare delivery system may influence the relationship between literacy and health outcomes.
doi:10.1186/1472-6963-8-219
PMCID: PMC2600788  PMID: 18947408

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