NCT06978127 · University of Pittsburgh
Technology Assisted Collaborative Care Intervention to Improve Patient-centered Outcomes in Dialysis Patients
(TACcare 2 0)
What this study is about
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.
View original scientific description
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.
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.
Primary outcome measures
TĀCcare 2.0 Effectiveness evaluation/Change in fatigue (co-primary outcome)
Time frame: 6 months
Change in fatigue is a primary outcome. The Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) will be used to measure fatigue. Scores range from 0-52 with lower scores indicating greater fatigue.
TĀCcare 2.0 Effectiveness evaluation/Change in Pain Intensity (co-primary outcome)
Time frame: 6 months
Change in pain intensity score is also a primary outcome measure. The Brief Pain Inventory (BPI) will be used to measure pain intensity. The BPI uses a scale of 0 to 10. Higher scores on the pain intensity scale indicate greater pain severity.
TĀCcare 2.0 Effectiveness evaluation/Change in Depression (co-primary outcome)
Time frame: 6 months
Change in depression severity score is also a primary outcome measure. The Beck Depression Inventory-II will be used to measure the depression severity score. Each item is scored on a 4 point scale ranging from 0 to 3, allowing for a total score ranging from 0 to 63. Higher scores indicate more severe symptoms.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Eligibility Criteria:
- age 18 years or older;
- undergoing thrice-weekly maintenance hemodialysis (HD) for \> 3 months;
- English or Spanish speaking;
- able to provide informed consent Ineligibility Criteria:
- active thought disorder, delusions or active suicidal ideation
- active substance abuse
- enrolled in hospice or life expectancy \< 6 months (based on clinician's judgement)
- too ill or cognitively impaired to participate based on renal provider's judgement
- living kidney transplant scheduled in \<3 months
- undergoing active cancer treatment.
- enrolled in another research study
- plan to transition to home dialysis within 3 months
- plan to move to another dialysis facility within 3 months
Where
- Albuquerque, New Mexico
- Pittsburgh, Pennsylvania
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of New Mexico
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 2, 2026 · Source of record for eligibility and locations