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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

The goal of this study is to learn if a collaborative care intervention of pharmaco-therapy and/or cognitive behavioral therapy (CBT), delivered in a real-world setting, improves symptoms of pain, fatigue and/or depression.

Description

The goal of this study is to conduct a hybrid Type II effectiveness-implementation, cluster randomized trial of TĀCcare 2.0 facilitated by dialysis staff in a real-world setting. This is a multi-center, dialysis-clinic level cluster randomized trial of 424 patients from 36 dialysis clinics comparing TACcare 2.0 facilitated by dialysis staff versus usual care. Patients' dialysis clinic will be placed randomly into one of two study groups: the Technology Assisted Stepped Collaborative Care Intervention Group or the Usual Care Group.

The intervention will target three of the most debilitating End State Kidney Disease (ESKD) related symptoms- fatigue, pain and depression. A stepped collaborative care approach for pharmaco and/or CBT allows for shared decision-making and individualization of treatment according to a patient's clinical status, preferences and treatment response. The TĀCcare 2.0 intervention will build on successful design elements of the original intervention, enhance depression management strategies and increase durability of effect by incorporating monthly longitudinal telemedicine-delivered booster sessions to complete a total 12-month intervention. Additionally, using a collaborative care approach, the patients' symptom management will be integrated with their dialysis treatment, thus increasing patient acceptability and adherence.

Eligibility

Eligibility Criteria:

  1. age 18 years or older;
  2. undergoing thrice-weekly maintenance hemodialysis (HD) for > 3 months;
  3. English or Spanish speaking;
  4. able to provide informed consent

Ineligibility Criteria:

  1. active thought disorder, delusions or active suicidal ideation
  2. active substance abuse
  3. enrolled in hospice or life expectancy < 6 months (based on clinician's judgement)
  4. too ill or cognitively impaired to participate based on renal provider's judgement
  5. living kidney transplant scheduled in <3 months
  6. undergoing active cancer treatment.
  7. enrolled in another research study
  8. plan to transition to home dialysis within 3 months
  9. plan to move to another dialysis facility within 3 months

Study details
    Chronic Kidney Disease Requiring Hemodialysis

NCT06978127

University of Pittsburgh

15 October 2025

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