The effects of a telehealth coping skills intervention on outcomes in chronic obstructive pulmonary disease: primary results from the INSPIRE-II study.

OBJECTIVE: Chronic obstructive pulmonary disease (COPD) is associated with increased morbidity and mortality and reduced quality of life (QoL). Novel interventions are needed to improve outcomes in COPD patients. The present study assessed the effects of a telephone-based coping skills intervention on psychological and somatic QoL and on the combined medical end point of COPD-related hospitalizations and all-cause mortality. METHODS: We conducted a dual-site, randomized clinical trial with assessments at baseline and after 16 weeks of treatment. The study population comprised 326 outpatients with COPD aged 38 to 81 years, randomized to coping skills training (CST) or to COPD education (COPD-ED). Patients completed a battery of QoL instruments, pulmonary function tests, and functional measures and were followed up for up to 4.4 years to assess medical outcomes. RESULTS: The CST group exhibited greater improvements in psychological QoL compared with controls (p = .001), including less depression (Cohen d = 0.22 [95% confidence interval, or CI = 0.08-0.36]) and anxiety (d = 0.17 [95% CI = 0.02-0.33]), and better overall mental health (d = 0.17 [95% CI = 0.03-0.32]), emotional role functioning (d = 0.29 [95% CI = 0.10-0.48]), vitality (d = 0.27 [95% CI = 0.11, 0.42]), and social functioning (d = 0.21 [95% CI = 0.03-0.38]). A significant baseline psychological QoL by treatment group interaction revealed that CST with lower QoL at baseline achieved even greater improvements in psychological QoL compared with COPD-ED. CST participants also exhibited greater improvements in somatic QoL (p = .042), including greater improvements in pulmonary QoL (d = 0.13 [95% CI = 0.01-0.24]), less fatigue (d = 0.34 [95% CI = 0.18-0.50]), and less shortness of breath (d = 0.11 [95% CI = -0.01 to 0.23]) and greater improvement in distance walked on the Six-Minute Walk test (d = 0.09 [95% CI = 0.01-0.16]). However, there was no significant difference in risk of time to COPD-related hospitalization or all-cause mortality between CST (34 events) and COPD-ED (32 events; p = 0.430). CONCLUSIONS: A telehealth CST intervention produced clinically meaningful improvements in QoL and functional capacity, but no overall improvement in risk of COPD-related hospitalization and all-cause mortality. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00736268.

Determinants and consequences of adherence to the dietary approaches to stop hypertension diet in African-American and white adults with high blood pressure: results from the ENCORE trial.

BACKGROUND: Although the Dietary Approaches to Stop Hypertension (DASH) diet is an accepted nonpharmacologic treatment for hypertension, little is known about what patient characteristics affect dietary adherence and what level of adherence is needed to reduce blood pressure (BP). OBJECTIVE: Our aim was to determine what factors predict dietary adherence and the extent to which dietary adherence is necessary to produce clinically meaningful BP reductions. DESIGN: Ancillary study of the ENCORE (Exercise and Nutrition Interventions for Cardiovascular Health) trial--a 16-week randomized clinical trial of diet and exercise. PARTICIPANTS/SETTING: Participants included 144 sedentary, overweight, or obese adults (body mass index 25 to 39.9) with high BP (systolic 130 to 159 mm Hg and/or diastolic 85 to 99 mm Hg). INTERVENTION: Patients were randomized to one of three groups: DASH diet alone, DASH diet plus weight management, and Usual Diet Controls. MAIN OUTCOMES MEASURES: Our primary outcomes were a composite index of adherence to the DASH diet and clinic BP. STATISTICAL ANALYSES PERFORMED: General linear models were used to compare treatment groups on post-treatment adherence to the DASH diet. Linear regression was used to examine potential predictors of post-treatment DASH adherence. Analysis of covariance was used to examine the relation of adherence to the DASH diet and BP. RESULTS: Participants in the DASH diet plus weight management (16.1 systolic BP [SBP]; 95% CI 13.0 to 19.2 mm Hg and 9.9 diastolic BP [DBP]; 95% CI 8.1 to 11.6 mm Hg) and DASH diet alone (11.2 SBP; 95% CI 8.1 to 14.3 mm Hg and 7.5 DBP; 95% CI 5.8 to 9.3 mm Hg) groups showed significant reductions in BP in comparison with Usual Diet Controls participants (3.4 SBP; 95% CI 0.4 to 6.4 mm Hg and DBP 3.8; 95% CI 2.2 to 5.5 mm Hg). Greater post-treatment consumption of DASH foods was noted in both the DASH diet alone (mean = 6.20; 95% CI 5.83 to 6.57) and DASH diet plus weight management groups (mean = 6.23; 95% CI 5.88 to 6.59) compared with Usual Diet Controls (mean = 3.66; 95% CI 3.30 to 4.01; P<0.0001), and greater adherence to the DASH diet was associated with larger reductions in clinic SBP and DBP (P ≤ 0.01). Only ethnicity predicted dietary adherence, with African Americans less adherent to the DASH diet compared with whites (4.68; 95% CI 4.34 to 5.03 vs 5.83; 95% CI 5.50 to 6.11; P<0.001). CONCLUSIONS: Greater adherence to the DASH diet was associated with larger BP reductions independent of weight loss. African Americans were less likely to be adherent to the DASH dietary eating plan compared with whites, suggesting that culturally sensitive dietary strategies might be needed to improve adherence to the DASH diet.

Understanding prognostic benefits of exercise and antidepressant therapy for persons with depression and heart disease: the UPBEAT study--rationale, design, and methodological issues.

BACKGROUND: Depression is relatively common in patients with coronary heart disease (CHD) and is associated with worse prognosis. Recently there has been interest in evaluating the impact of treating depression on clinical outcomes. Anti-depressant medications have been shown to be safe and efficacious for many patients; exercise also may be effective for treating depression and may also improve cardiopulmonary functioning. However, methodological limitations of previous studies have raised questions about the value of exercise, and no study has compared the effects of exercise with standard anti-depressant medication in depressed cardiac patients. PURPOSE: UPBEAT is a randomized clinical trial (RCT) funded by NHLBI to evaluate the effects of sertraline or exercise compared to placebo on depression and biomarkers of cardiovascular risk in patients with CHD and elevated depressive symptoms. METHODS: The UPBEAT study includes 200 stable CHD patients with scores on the Beck Depression Inventory (BDI) > or =9 randomized to 4 months of treatment with aerobic exercise, sertraline, or placebo. The primary outcomes include depressive symptoms determined by clinical ratings on the Hamilton Rating Scale for Depression (HAM-D) and measures of heart rate variability (HRV), baroreflex control (BRC), vascular function (i.e., flow-mediated dilation (FMD)), and measures of inflammation and platelet aggregation. RESULTS: This article reviews the rationale and design of UPBEAT and addresses several key methodologic issues that were carefully considered in the development of this protocol: the use of a placebo control condition in depressed cardiac patients, study design, and selection of intermediate endpoints or biomarkers of cardiovascular risk. LIMITATIONS: This study is not powered to assess treatment group differences in CHD morbidity and mortality. Intermediate endpoints are not equivalent to 'hard' clinical events and further studies are needed to determine the clinical significance of these biomarkers. CONCLUSIONS: The UPBEAT study is designed to assess the efficacy of exercise in treating depression in cardiac patients and evaluates the impact of treating depression on important biomarkers of cardiovascular risk.