Actively Recruiting
Technology Assisted Collaborative Care Intervention (TĀCcare) 2.0 Implementation Trial to Improve Patient-centered Outcomes in Patients on Hemodialysis
Led by University of Pittsburgh · Updated on 2026-02-02
424
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Pittsburgh
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
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 and/or 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.
CONDITIONS
Brief Title
Technology Assisted Collaborative Care Intervention to Improve Patient-centered Outcomes in Dialysis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Undergoing thrice-weekly maintenance hemodialysis for more than 3 months
- Able to speak English or Spanish
- Able to provide informed consent
You will not qualify if you...
- Active thought disorder, delusions, or active suicidal ideation
- Active substance abuse
- Enrolled in hospice or life expectancy less than 6 months based on clinician's judgment
- Too ill or cognitively impaired to participate based on renal provider's judgment
- Scheduled living kidney transplant within less than 3 months
- Undergoing active cancer treatment
- Enrolled in another research study
- Planning to transition to home dialysis within 3 months
- Planning to move to another dialysis facility within 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants in the Technology Assisted Stepped Collaborative Care group receive pharmacotherapy recommendations and/or Cognitive Behavioral Therapy (CBT) through 12 weekly telehealth sessions. Booster sessions continue monthly to complete a total 12-month intervention integrated with dialysis treatment. Participants in the Usual Care Group continue with their usual care.
Weekly telehealth sessions for 12 weeks, followed by monthly booster sessions
Duration - Up to 12 months
Participants complete phone surveys about their symptoms and health at multiple timepoints to monitor treatment effectiveness and health outcomes.
Assessments at 3, 6, and 12 months
Trial Site Locations
Total: 2 locations
1
UNM
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
2
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
M
Manisha Jhamb, MD, MPH
M
Mark Unruh, MD, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here