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

Conditions

• Chronic Kidney Disease Requiring Hemodialysis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Technology Assisted Stepped Collaborative Care — BEHAVIORAL
  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.
• Usual Care Arm — OTHER
  Participants in the Usual Care Arm will continue with their usual care.

Study Details

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.

Key Dates

Start date

Aug 28, 2025

Status verified

Sep 2025

Primary completion

Jun 30, 2029

Completion

Jun 30, 2029

Study Design

Enrollment

424 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Technology Assisted Stepped Collaborative Care Group
  Participants in the Technology Assisted Stepped Collaborative Care group will receive a stepped-approach for pharmaco and/or Cognitive Behavioral Therapy (CBT) and individualization of treatment to improve symptoms of fatigue, pain and/or depression, in a real-world setting.
• Active Comparator: Usual Care Group
  Participants in the Usual Care Group will continue with their usual care.

Primary Outcome Measure

TĀCcare 2.0 Effectiveness evaluation/Change in fatigue (co-primary outcome) [ Time Frame: 6 months ]

Central Contacts

• Manisha Jhamb, MD, MPH
  412-647-7062
  [email protected]
• Mark Unruh, MD, MS
  (505) 272-0407
  [email protected]

Locations (2)

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