Effect of a Behavioral Self-Regulation Intervention on Patient Adherence to Fluid-Intake Restrictions in Hemodialysis: a Randomized Controlled Trial.

OBJECTIVE: The purpose of this study is to evaluate the efficacy of a behavioral self-regulation intervention vs. active control condition using a parallel-group randomized clinical trial with a sample of center hemodialysis patients with chronic kidney disease. METHOD: Participants were recruited from 8 hemodialysis treatment centers in the Midwest. Eligible patients were (a) fluid nonadherent as defined by an interdialytic weight gain >2.5 kg over a 4-week period, (b) >18 years of age, (c) English-speaking without severe cognitive impairment, (d) treated with center-based hemodialysis for >3 months, and (e) not living in a care facility in which meals were managed. Medical records were used to identify eligible patients. Patients were randomly assigned to either a behavioral self-regulation intervention or active control condition in which groups of 3-8 patients met for hour-long, weekly sessions for 7 weeks at their usual hemodialysis clinic. Primary analyses were intention-to-treat. RESULTS: Sixty-one patients were randomized to the intervention while 58 were assigned to the attention-placebo support and discussion control. Covariate-adjusted between-subjects analyses demonstrated no unique intervention effect for the primary outcome, interdialytic weight gain (ß = 0.13, p = 0.48). Significant within-subjects improvement over time was observed for the intervention group (ß = -0.32, p = 0.014). CONCLUSIONS: The present study found that participation in a behavioral self-regulation intervention resulted in no unique intervention effect on a key indicator of adherence for those with severe chronic kidney disease. There was, however, modest within-subjects improvement in interdialytic weight gain for the intervention group which meshes with other evidence showing the utility of behavioral interventions in this patient population. ClinicalTrials.gov Identifier: NCT01066949.

Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke.

BACKGROUND: Recurrent stroke is a frequent, disabling event after ischemic stroke. This study compared the efficacy and safety of two antiplatelet regimens--aspirin plus extended-release dipyridamole (ASA-ERDP) versus clopidogrel. METHODS: In this double-blind, 2-by-2 factorial trial, we randomly assigned patients to receive 25 mg of aspirin plus 200 mg of extended-release dipyridamole twice daily or to receive 75 mg of clopidogrel daily. The primary outcome was first recurrence of stroke. The secondary outcome was a composite of stroke, myocardial infarction, or death from vascular causes. Sequential statistical testing of noninferiority (margin of 1.075), followed by superiority testing, was planned. RESULTS: A total of 20,332 patients were followed for a mean of 2.5 years. Recurrent stroke occurred in 916 patients (9.0%) receiving ASA-ERDP and in 898 patients (8.8%) receiving clopidogrel (hazard ratio, 1.01; 95% confidence interval [CI], 0.92 to 1.11). The secondary outcome occurred in 1333 patients (13.1%) in each group (hazard ratio for ASA-ERDP, 0.99; 95% CI, 0.92 to 1.07). There were more major hemorrhagic events among ASA-ERDP recipients (419 [4.1%]) than among clopidogrel recipients (365 [3.6%]) (hazard ratio, 1.15; 95% CI, 1.00 to 1.32), including intracranial hemorrhage (hazard ratio, 1.42; 95% CI, 1.11 to 1.83). The net risk of recurrent stroke or major hemorrhagic event was similar in the two groups (1194 ASA-ERDP recipients [11.7%], vs. 1156 clopidogrel recipients [11.4%]; hazard ratio, 1.03; 95% CI, 0.95 to 1.11). CONCLUSIONS: The trial did not meet the predefined criteria for noninferiority but showed similar rates of recurrent stroke with ASA-ERDP and with clopidogrel. There is no evidence that either of the two treatments was superior to the other in the prevention of recurrent stroke. (ClinicalTrials.gov number, NCT00153062.)

Telmisartan to prevent recurrent stroke and cardiovascular events.

BACKGROUND: Prolonged lowering of blood pressure after a stroke reduces the risk of recurrent stroke. In addition, inhibition of the renin-angiotensin system in high-risk patients reduces the rate of subsequent cardiovascular events, including stroke. However, the effect of lowering of blood pressure with a renin-angiotensin system inhibitor soon after a stroke has not been clearly established. We evaluated the effects of therapy with an angiotensin-receptor blocker, telmisartan, initiated early after a stroke. METHODS: In a multicenter trial involving 20,332 patients who recently had an ischemic stroke, we randomly assigned 10,146 to receive telmisartan (80 mg daily) and 10,186 to receive placebo. The primary outcome was recurrent stroke. Secondary outcomes were major cardiovascular events (death from cardiovascular causes, recurrent stroke, myocardial infarction, or new or worsening heart failure) and new-onset diabetes. RESULTS: The median interval from stroke to randomization was 15 days. During a mean follow-up of 2.5 years, the mean blood pressure was 3.8/2.0 mm Hg lower in the telmisartan group than in the placebo group. A total of 880 patients (8.7%) in the telmisartan group and 934 patients (9.2%) in the placebo group had a subsequent stroke (hazard ratio in the telmisartan group, 0.95; 95% confidence interval [CI], 0.86 to 1.04; P=0.23). Major cardiovascular events occurred in 1367 patients (13.5%) in the telmisartan group and 1463 patients (14.4%) in the placebo group (hazard ratio, 0.94; 95% CI, 0.87 to 1.01; P=0.11). New-onset diabetes occurred in 1.7% of the telmisartan group and 2.1% of the placebo group (hazard ratio, 0.82; 95% CI, 0.65 to 1.04; P=0.10). CONCLUSIONS: Therapy with telmisartan initiated soon after an ischemic stroke and continued for 2.5 years did not significantly lower the rate of recurrent stroke, major cardiovascular events, or diabetes. (ClinicalTrials.gov number, NCT00153062.)

Effects of aspirin plus extended-release dipyridamole versus clopidogrel and telmisartan on disability and cognitive function after recurrent stroke in patients with ischaemic stroke in the Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) trial: a double-blind, active and placebo-controlled study.

BACKGROUND: The treatment of ischaemic stroke with neuroprotective drugs has been unsuccessful, and whether these compounds can be used to reduce disability after recurrent stroke is unknown. The putative neuroprotective effects of antiplatelet compounds and the angiotensin II receptor antagonist telmisartan were investigated in the Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) trial. METHODS: Patients who had had an ischaemic stroke were randomly assigned in a two by two factorial design to receive either 25 mg aspirin (ASA) and 200 mg extended-release dipyridamole (ER-DP) twice a day or 75 mg clopidogrel once a day, and either 80 mg telmisartan or placebo once per day. The predefined endpoints for this substudy were disability after a recurrent stroke, assessed with the modified Rankin scale (mRS) and Barthel index at 3 months, and cognitive function, assessed with the mini-mental state examination (MMSE) score at 4 weeks after randomisation and at the penultimate visit. Analysis was by intention to treat. The study was registered with ClinicalTrials.gov, number NCT00153062. FINDINGS: 20,332 patients (mean age 66 years) were randomised and followed-up for a median of 2.4 years. Recurrent strokes occurred in 916 (9%) patients randomly assigned to ASA with ER-DP and 898 (9%) patients randomly assigned to clopidogrel; 880 (9%) patients randomly assigned to telmisartan and 934 (9%) patients given placebo had recurrent strokes. mRS scores were not statistically different in patients with recurrent stroke who were treated with ASA and ER-DP versus clopidogrel (p=0.38), or with telmisartan versus placebo (p=0.61). There was no significant difference in the proportion of patients with recurrent stroke with a good outcome, as measured with the Barthel index, across all treatment groups. Additionally, there was no significant difference in the median MMSE scores, the percentage of patients with an MMSE score of 24 points or less, the percentage of patients with a drop in MMSE score of 3 points or more between 1 month and the penultimate visit, and the number of patients with dementia among the treatment groups. There were no significant differences in the proportion of patients with cognitive impairment or dementia among the treatment groups. INTERPRETATION: Disability due to recurrent stroke and cognitive decline in patients with ischaemic stroke were not different between the two antiplatelet regimens and were not affected by the preventive use of telmisartan.

Peritoneal Dialysis for AKI in Cameroon: Commercial vs Locally-Made Solutions.

BACKGROUND: Acute kidney injury (AKI) is common in low- and middle-income countries, and is associated with a high mortality. The high mortality rate is in large part due to the inability to perform dialysis in resource-limited settings. Due to significant cost advantages, peritoneal dialysis (PD) has been used to treat AKI in these settings. The costs, however, remain high when commercial solutions are used. METHODS: This is a retrospective cohort study of the outcome, and of the peritonitis rates, of patients with AKI treated with either commercially manufactured PD solutions or locally-made PD solutions. A program to treat AKI with PD was started at Mbingo Baptist Hospital in Cameroon. Between May 2013 and January 2015, solutions and connection sets were provided by the Saving Young Lives Program. From January 2015 through March 2017, solutions were locally produced and available tubing was used. RESULTS: Mortality in hospitalized AKI patients was 28% during the period when commercial solutions and tubing were utilized, and 33% when locally produced solutions and available tubing were utilized. In both groups, peritonitis occurred in 16% of treatment courses. CONCLUSIONS: Locally produced PD solutions, used with locally available tubing, were used to treat AKI with PD. The mortality and peritonitis rates were similar whether locally produced or commercial supplies were used.

The role of depression symptoms in dialysis withdrawal.

Among end-stage renal disease (ESRD) patients on hemodialysis, death from withdrawal from life-sustaining dialysis is increasingly common. The present study's objective was to examine depression as a potential risk factor for hemodialysis withdrawal. Two hundred forty ESRD hemodialysis (133 male and 107 female) patients were followed for an average of 4 years after depression symptom assessment. Of these, 18% withdrew from dialysis. Using multivariate survival analysis and after controlling for the effects of age (p < .001) and clinical variables, the authors found that level of depression symptoms was a unique and significant predictive risk factor for the subsequent decision to withdraw from dialysis (p < .05). The potential impact that depression may have on the decision to withdraw from hemodialysis should be considered by health care providers, patient families, and patients.

Health locus of control and depression in chronic kidney disease: a dynamic perspective.

Participants in the present study were 207 patients with chronic kidney disease (CKD) who completed internal HLOC and depression measures at baseline and at an approximately 16-month follow-up period. Regression results indicated that after controlling for baseline level of depression, baseline internal HLOC was not a significant predictor of depression at follow-up. However, increases in internal HLOC over the 16-month follow-up were predictive of depression at follow-up. Furthermore, this relationship was qualified by an interaction between change in internal HLOC and disease progression. These results suggest that changes in internal HLOC over time may be a particularly important determinant of adjustment for individuals whose chronic illness progresses or becomes life threatening.

Effect of a behavioral self-regulation intervention on patient adherence in hemodialysis.

The present study examined the efficacy of a behavioral intervention designed to increase adherence to fluid-intake restrictions among hemodialysis patients. Twenty intervention-group patients were compared with 20 matched control patients on an indicator of fluid-intake adherence at 3 time points. The Group x Time interaction was significant, indicating that patients in the 2 groups exhibited a differential pattern of change in fluid-intake adherence across the follow-up period. The intervention and control groups did not differ significantly in terms of adherence at the initial postintervention period but did differ at the 8-week follow-up. The observed group differences were, in part, due to a trend toward increasingly better adherence in the intervention group and poorer adherence in the control group across the follow-up period.

Patient personality and mortality: a 4-year prospective examination of chronic renal insufficiency.

The present study examined the role of personality as a predictor of mortality among patients with chronic renal insufficiency. A prospective evaluation of the influence of personality on patient survival was conducted over an average 49-month period. Cox regression was used to evaluate the effects of 5 dimensions of personality in a sample of 174 patients (100 male and 74 female). At follow-up, 49 patients had died. Significant demographic and clinical predictors of survival included age, diabetic status, and hemoglobin level. After these predictors were controlled for, 2 personality traits, conscientiousness and neuroticism, predicted patient mortality. Patients with high neuroticism scores had a 37.5% higher estimated mortality rate. Patients with low conscientiousness scores had a 36.4% increased mortality rate.

Association between depressive symptoms and mortality risk in chronic kidney disease.

OBJECTIVE: Previous examinations of depression as a predictor of mortality in end-stage renal disease have yielded inconsistent findings. We sought to clarify the possible link with mortality by assessing depression at an earlier stage of renal impairment before the uremic disease state and depressive symptoms become highly confounded, and then following patients during the period of disease progression. DESIGN: Prospective design using an assessment of depression before initiation of renal replacement therapy to predict mortality status an average of 81 months later in patients in the early stages of chronic kidney disease. MAIN OUTCOME MEASURES: Mortality status. RESULTS: After controlling for relevant mortality risk factors (i.e., age, gender, presence of diabetes and cardiovascular disease, and potassium level), results of Cox regression analyses indicated that higher levels of nonsomatic depression symptoms were predictive of an increased mortality risk, χ²(1, N = 359) = 8.02, p = .005. Patients with nonsomatic depression scores 1 SD above the mean had an estimated mortality rate 21.4% higher than average scorers in this sample. CONCLUSION: Clinical implications of these findings point to the importance of assessment and treatment of depressive symptoms in patients with chronic kidney disease.

A longitudinal examination of social support, agreeableness and depressive symptoms in chronic kidney disease.

Research examining the role of social support in patient adjustment to chronic illness has been inconsistent suggesting that patient individual differences play a moderating role. This study examined the hypothesis that the relationship between social support and depressive symptoms would differ as a function of individual differences in trait Agreeableness. Fifty-nine patients with chronic kidney disease were assessed using the Social Provisions Scale, Beck Depression Inventory and NEO-Five-Factor Inventory and were followed-up a year and a half later. After controlling for baseline depressive symptoms and clinical characteristics, regression analyses revealed a significant interaction between social support and Agreeableness predicting change in depressive symptoms. Greater social support among individuals high in Agreeableness was associated with a decrease in depressive symptoms over time, while support had little effect on depression change for individuals low in Agreeableness. These findings underscore the importance of individual difference variables in understanding adjustment to chronic illness.

The role of perceived control and preference for control in adherence to a chronic medical regimen.

BACKGROUND: Poor patient adherence is a widespread problem among patients undergoing hemodialysis for end-stage renal disease. PURPOSE: The goal of this study was to examine the joint role of perceived restriction of control and individual differences in preference for control in predicting adherence to the hemodialysis regimen. METHODS: Participants were 49 patients recruited from five hemodialysis centers affiliated with the University of Iowa Hospitals and Clinics. Preference for control in the health care context was assessed using the Preference for Information and Preference for Behavioral Involvement subscales of the Krantz Health Opinion Survey, and perceived control was assessed using six items written for this study. Adherence was assessed by examining patients' interdialysis session weight gains (IWG). RESULTS: Hierarchical regression analysis indicated that the interaction between preference for information and perceived control over dialysis context explained a significant proportion of variance in IWG values, change in R2 =.09, F(1, 43) = 5.26, p <.05, standardized beta = -.32. Among patients with lower levels of perceived control in the dialysis setting, a higher preference for information concerning one's own health care was associated with increasingly poorer adherence. IWG levels in these individuals reflected clinically problematic nonadherence with fluid-intake restrictions. Among patients with a higher level of perceived control, preference for information had little effect on adherence. No main or interactive effects were found involving differences in patients' preference for behavioral involvement in their own health care or for the items reflecting perceived control outside the dialysis treatment setting. CONCLUSIONS: These data suggest that assessing and examining the interactive effects of patients' preferences for control and perceived control may, in some cases, be useful in identifying those individuals at risk for difficulty in adhering to the complex behavioral restrictions associated with chronic medical regimens.

Value of MR angiography before percutaneous transluminal renal artery angioplasty and stent placement.

PURPOSE: To determine the benefit of preprocedural three-dimensional gadolinium (Gd)-enhanced magnetic resonance (MR) angiography before percutaneous transluminal renal artery angioplasty and stent placement (PTRA/S) in terms of procedural success, iodinated contrast material load, and procedure duration. MATERIALS AND METHODS: Over an 18-month period, 39 patients underwent attempted percutaneous renal angioplasty with or without stent placement. A total of 48 renal arteries were treated (40 cases of atherosclerosis, one of stent restenosis, five of fibromuscular dysplasia, and two of transplant stenosis). Preprocedural Gd-enhanced MR angiography was available in 16 procedures (41%). Procedural outcome, complications, iodinated contrast material load, number of diagnostic angiographic runs, and total procedure duration were each compared between two subgroups: patients who had preprocedural Gd-enhanced MR angiography ("prior MR angiography group") and those who did not ("no MR angiography" group). RESULTS: All procedures were technically successful. The two groups were equivalent in terms of age and disease pattern. However, technical complexity of the procedure was judged to be high in five of 16 procedures in the prior MR angiography group compared to three of 23 procedures in the no MR angiography group (P =.16). Bilateral or dual interventions were performed in six of 16 procedures in the prior MR angiography group compared to three of 23 in the no MR angiography group (P =.075). Iodinated contrast material load was significantly lower in the prior MR angiography group than in the no MR angiography group (68.7 mL +/- 28.4 vs 119.1 mL +/- 49.2 mL;P <.0008). The number of diagnostic angiographic runs before interventions were also significantly lower in the prior MR angiography group (1.2 +/- 0.4 vs 2.6 +/- 0.7; P <.0001). Overall procedure duration was comparable between the two groups (91.9 +/- 47.8 vs 112.2 +/- 49.4;P =.2). CONCLUSION: Preprocedural planning with use of Gd-enhanced MR angiography significantly reduces the iodinated contrast material requirement during percutaneous renal artery interventions. It can also significantly shorten procedure duration.