Study of Technology Assisted Collaborative Care TCcare 2.0 to Improve Pain, Fatigue, and Depression in Adults on Hemodialysis

What this Trial Is About

Researchers are evaluating a collaborative care intervention called TACcare 2.0 to improve symptoms of fatigue, pain, and depression in patients with end-stage kidney disease ESKD who are undergoing hemodialysis. This multi-center, cluster randomized trial compares this technology-assisted stepped collaborative care approach to usual care in 424 patients from 36 dialysis clinics. The study aims to assess the effectiveness of integrating symptom management with dialysis treatment in a real-world setting. Participants in the Technology Assisted Stepped Collaborative Care group will receive personalized treatment involving pharmacotherapy andor cognitive behavioral therapy CBT. The CBT is delivered through 12 weekly telehealth sessions during dialysis or at home, followed by monthly booster sessions over a total 12-month intervention period. The intervention focuses on shared decision-making and adjusts treatment based on patient preferences and clinical response. The usual care group will continue their standard treatment without the collaborative care intervention. During the study, participants will complete phone surveys about their symptoms and health at various intervals. Researchers will monitor changes in fatigue, pain intensity, and depression over 6 months as co-primary outcomes. Secondary outcomes include assessments of symptom burden, sleep quality, anxiety, quality of life, social support, treatment adherence, and healthcare utilization up to 12 months. This longitudinal evaluation aims to understand the impact of the intervention on patient-centered outcomes while maintaining safety and adherence.

Technology Assisted Collaborative Care Intervention to Improve Patient-centered Outcomes in Dialysis Patients