There is little published guidance concerning how large a pilot study should be. General guidelines, for example using 10% of the sample required for a full study, may be inadequate for aims such as assessment of the adequacy of instrumentation or providing statistical estimates for a larger study. This article illustrates how confidence intervals constructed around a desired or anticipated value can help determine the sample size needed. Samples ranging in size from 10 to 40 per group are evaluated for their adequacy in providing estimates precise enough to meet a variety of possible aims. General sample size guidelines by type of aim are offered.

BackgroundHeart failure (HF) patients discharged from rural hospitals have higher 30-day readmission rates. Self-management (SM) reduces readmissions, but adherence to SM guidelines is low in the rural HF population. We tested a home-based intervention to enhance patient activation and lead to improved SM adherence.MethodsIn this two-group, repeated measures randomized control trial, the main outcomes were patient reported and clinical outcomes associated with SM adherence, and all-cause readmission at 30, 90 and 180 days.ResultsThe study included 100 HF patients discharged from a rural critical access hospital. The intervention group received a 12-week SM training and coaching program delivered by telephone and tailored on subjects’ activation levels. At α = .10, the PATCH intervention showed significantly greater improvement compared to usual care in patient-reported SM adherence: weighing themselves, following a low-sodium diet, taking prescribed medication, and exercising daily (all p < .0005) at 3 and 6 months after discharge. In contrast, groups did not differ in physical activity assessed by actigraphy or in clinical biomarkers. Contrary to expectation, the 30-day readmission rate was significantly higher (p = .088) in the intervention group (19.6 %) than in the control group (6.1 %), with no differences at 90 or 180 days.ConclusionIt is feasible to conduct a randomized controlled trial in HF patients discharged from rural critical access hospitals. Significantly higher patient-reported SM adherence was not accompanied by lower clinical biomarkers or readmission rates. Further research is needed to understand mechanisms that influence outcomes and healthcare utilization in this population.Trial registrationClinical Trial Registration Information: ClinicalTrials.gov; NCT01964053.

This pilot study examined the impact of a hospital transition intervention for older adults (≥ 65 years of age) with heart failure (HF) to promote medication use self-management. Forty subjects, hospitalized with either primary or secondary HF, had a mean age of 76.9 ± 6.5 years; 65% were males. The majority of subjects (55%) had NYHA Class III HF. A prospective, repeated measures experimental design was used. Baseline and follow-up data (1- and 3-months after hospitalization) were obtained using the Medication Regimen Complexity Index, Brief Medication Questionnaire, Drug Regiment Unassisted Grading Scale, and Kansas City Cardiomyopathy Questionnaire. Using repeated measures analysis of covariance (ANCOVA), with baseline measures as covariates, the transition intervention group had higher levels of medication adherence (F(1,35) = 13.4, p < .001), self-efficacy for HF self-care (F(1,35) = 17.9, p < .001) and had significantly fewer HF related symptoms that impaired health related quality of life (F(1,35) = 9.1, p = .006).

Open-heart surgery patients report anxiety and pain with chair rest despite opioid analgesic use. The effectiveness of non-pharmacological complementary methods (sedative music and scheduled rest) in reducing anxiety and pain during chair rest was tested using a three-group pretest-posttest experimental design with 61 adult postoperative open-heart surgery patients. Patients were randomly assigned to receive 30 min of sedative music (N=19), scheduled rest (N=21), or treatment as usual (N=21) during chair rest. Anxiety, pain sensation, and pain distress were measured with visual analogue scales at chair rest initiation and 30 min later. Repeated measures MANOVA indicated significant group differences in anxiety, pain sensation, and pain distress from pretest to posttest, P<0.001. Univariate repeated measures ANOVA (P< or =0.001) and post hoc dependent t-tests indicated that in the sedative music and scheduled rest groups, anxiety, pain sensation, and pain distress all decreased significantly, P<0.001-0.015; while in the treatment as usual group, no significant differences occurred. Further, independent t-tests indicated significantly less posttest anxiety, pain sensation, and pain distress in the sedative music group than in the scheduled rest or treatment as usual groups (P<0.001-0.006). Thus, in this randomized control trial, sedative music was more effective than scheduled rest and treatment as usual in decreasing anxiety and pain in open-heart surgery patients during first time chair rest. Patients should be encouraged to use sedative music as an adjuvant to medication during chair rest.

Disrupted patterns of circadian activity rhythms were prevalent and associated with distressing fatigue and depressive symptoms during chemotherapy and at recovery. The intervention resulted in more robust rhythms.

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Of 139 respondents, 33 (24%) were female and 106 (76%) were male. The mean (SD) age was 70.6 (9.7) years, and all were white, except for a single African American female. Most subjects were married (84%) with a median level of high school education, and 5% were New York Heart Association classification I, 38% class II, 52% class III, and 5% class IV. Hierarchical cluster analysis was used to derive a 3-cluster solution based on the presence or absence of 14 symptoms. Cluster 1 patients had significantly lower incidence of symptoms and were more likely to be New York Heart Association class I or class II, with lower body mass index and higher education levels compared with patients in the other clusters. Both clusters 2 and 3 were more symptomatic than cluster 1. Compared with cluster 3, patients in cluster 2 reported more shortness of breath under circumstances other than activity, and the majority reported difficulty sleeping. They also tended to report greater symptom severity and impact on physical activity and enjoyment of life. Additional differences included comorbidities and percentage of subjects on angiotensin-converting enzyme inhibitors or angiotensin receptor blockers. Examination of the clusters suggested clinical implications related to pharmacological management and raised questions concerning potential influences of duration of the heart failure condition, presence of sleep-disordered breathing, and impact of educational level on self-management behavior and symptom patterns.

Background-Unhealthy diet and lack of physical activity increase rural midlife and older women's risk for chronic diseases and premature death, and they are behind urban residents in meeting Healthy People 2010 objectives.