Technology-assisted stepped collaborative care for pain, fatigue, and depression in dialysis patients
Technology Assisted Collaborative Care Intervention (TĀCcare) 2.0 Implementation Trial to Improve Patient-centered Outcomes in Patients on Hemodialysis
This trial tests whether a technology-assisted stepped collaborative care program — combining medications and/or cognitive behavioral therapy delivered with dialysis staff support and telemedicine — can reduce pain, fatigue, and depression in adults on in-center hemodialysis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 424 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 2 sites (Albuquerque, New Mexico and 1 other locations) |
| Trial ID | NCT06978127 on ClinicalTrials.gov |
What this trial studies
TĀCcare 2.0 is being tested in a hybrid Type II effectiveness-implementation, cluster-randomized trial in which 36 dialysis clinics are randomized to the intervention or usual care, enrolling a total of 424 patients. The intervention uses a stepped collaborative care model that offers pharmacotherapy and/or cognitive behavioral therapy with shared decision-making and is facilitated by dialysis clinic staff. Monthly telemedicine booster sessions extend the intervention to 12 months to enhance depression management and durability of effect, while integrating symptom care into routine dialysis to improve acceptability and adherence. The trial is conducted at multiple U.S. centers including the University of Pittsburgh and the University of New Mexico.
Who should consider this trial
Good fit: Ideal candidates are adults (18+) who have been receiving thrice-weekly in-center hemodialysis for more than three months, speak English or Spanish, and can give informed consent.
Not a fit: Patients with active psychosis or suicidal ideation, uncontrolled substance abuse, life expectancy under six months, active cancer treatment, severe cognitive impairment, planned transplant or transition to home dialysis within three months, or those already in hospice are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the program could reduce pain, fatigue, and depression and improve overall quality of life and treatment adherence for people on maintenance hemodialysis.
How similar studies have performed: Previous collaborative care and CBT interventions in chronic disease and an earlier version of TĀCcare have shown promise for symptom improvement, but this trial tests the approach at larger scale and in real-world dialysis clinics.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Albuquerque, New Mexico and 1 other locations
- Unm — Albuquerque, New Mexico, United States (Recruiting)
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Manisha Jhamb, MD, MPH — University of Pittsburgh
- Study coordinator: Manisha Jhamb, MD, MPH
- Email: jhambm@upmc.edu
- Phone: 412-647-7062
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.