Technology-assisted stepped collaborative care for pain, fatigue, and depression in dialysis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.