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

NCT06978127 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 424

Last updated 2026-02-02

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Kidney Disease Requiring Hemodialysis

Interventions

BEHAVIORAL

Technology Assisted Stepped Collaborative Care

The TĀCcare 2.0 intervention will provide pharmacotherapy recommendations and/or CBT for pain, fatigue and depression. A stepped-treatment approach will be used to intensify treatment. CBT will be provided through 12 weekly telehealth sessions (done during dialysis treatment or from home) with the behavioral specialist. Booster sessions will be used to enhance the maintenance of effect following the initial intervention to complete a total 12 month intervention. A collaborative care approach will be used so that patients' symptom management will be integrated with their dialysis treatment. Throughout the study, participants will be asked to complete phone surveys about their symptoms and health.

OTHER

Usual Care Arm

Participants in the Usual Care Arm will continue with their usual care.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of New Mexico

    collaborator OTHER

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Manisha Jhamb, MD, MPH · University of Pittsburgh

  • Mark L Unruh, MS, MS · University of New Mexico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-28
Primary Completion
2029-06-30
Completion
2029-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06978127 on ClinicalTrials.gov