Hemodialysis Self-management Intervention Randomized Trial (HED-SMART): A Practical Low-Intensity Intervention to Improve Adherence and Clinical Markers in Patients Receiving Hemodialysis.

BACKGROUND: Poor adherence to treatment is common in hemodialysis patients. However, effective interventions for adherence in this population are lacking. Small studies of behavioral interventions have yielded improvements, but clinical effectiveness and long-term effects are unclear. STUDY DESIGN: Multicenter parallel (1:1) design, blinded cluster-randomized controlled trial. SETTING & PARTICIPANTS: Patients undergoing maintenance hemodialysis enrolled in 14 dialysis centers. INTERVENTION: Dialysis shifts of eligible patients were randomly assigned to either an interactive and targeted self-management training program (HED-SMART; intervention; n=134) or usual care (control; n=101). HED-SMART, developed using the principles of problem solving and social learning theory, was delivered in a group format by health care professionals over 4 sessions. OUTCOMES & MEASUREMENTS: Serum potassium and phosphate concentrations, interdialytic weight gains (IDWGs), self-reported adherence, and self-management skills at 1 week, 3 months, and 9 months postintervention. RESULTS: 235 participants were enrolled in the study (response rate, 44.2%), and 82.1% completed the protocol. IDWG was significantly lowered across all 3 assessments relative to baseline (P<0.001) among patients randomly assigned to HED-SMART. In contrast, IDWG in controls showed no change except at 3 months, when it worsened significantly. Improvements in mineral markers were noted in the HED-SMART arm at 3 months (P<0.001) and in potassium concentrations (P<0.001) at 9 months. Phosphate concentrations improved in HED-SMART at 3 months (P=0.03), but these effects were not maintained at 9 months postintervention. Significant differences between the arms were found for the secondary outcomes of self-reported adherence, self-management skills, and self-efficacy at all time points. LIMITATIONS: Low proportion of patients with diabetes. CONCLUSIONS: HED-SMART provides an effective and practical model for improving health in hemodialysis patients. The observed improvements in clinical markers and self-report adherence, if maintained at the longer follow-up, could significantly reduce end-stage renal disease-related complications. Given the feasibility of this kind of program, it has strong potential for supplementing usual care. TRIAL REGISTRATION: Registered at ISRCTN with study number ISRCTN31434033.

The effect of brief self-management intervention for hemodialysis patients (HED-SMART) on trajectories of depressive and anxious symptoms.

OBJECTIVE: Depression is often comorbid with End-Stage Renal Disease, and associated with poor adherence and clinical outcomes but course of symptoms is variable. This study sought to describe the long-term trajectories of anxiety and depression in hemodialysis patients, to identify predictors of these trajectories over 12 months and to evaluate the effectiveness of the HEmoDialysis Self-Management Randomized Trial (HED SMART) against usual care on symptoms of anxiety and depression. METHODS: A secondary analysis of data from a randomized controlled trial that contrasted HED SMART (n = 101) against usual care (n = 134). Depressive and anxious symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS) at baseline, 1 week and at 3 and 9 months post-intervention. Latent class growth analysis identified trajectories of depression and anxiety, and their sociodemographic and clinical predictors. RESULTS: Symptoms of depression and anxiety over 12 months were characterized by two trajectories: low stable (depression: 55%; anxiety: 59%) with non-clinical levels of distress, and high stable (depression: 45%; anxiety: 41%) with clinical levels of distress. HED SMART predicted significant reductions in depression relative to usual care. A similar trend was noted for anxiety. Younger age, Chinese ethnicity, and more comorbidities were associated with persistent high depression. Younger age and shorter dialysis vintage was associated with persistent high anxiety. CONCLUSION: A brief self-management intervention designed to support behavioral change can also lead to significant reductions in symptoms of depression and may be of great value for younger HD patients shown to be at greater risk for persistent distress. TRIAL REGISTRATION: ISRTN31434033.