TACcare 2018.

Study name	Rationale and design of technology assisted stepped collaborative care intervention to improve patient‐centered outcomes in hemodialysis patients (TACcare trial)
Methods	Study design RCT Duration of follow‐up: 12 months
Participants	Study characteristics Country: USA Setting: multicentre (Pennsylvania and New Mexico) Inclusion criteria ≥ 18 years Undergoing 3 times/week maintenance HD for over 3 months English or Spanish‐speaking Ability to provide informed signed consent No evidence of thought disorder, delusions, or active suicidal intent observed or reported Exclusion criteria Evidence of thought disorder, delusions or active suicidal intent – observed or reported Active substance abuse Too ill or cognitively impaired to participate based on clinicians’ judgement Anticipated life expectancy < 1 year Unable or unwilling to adhere to study protocol Participating in another clinical trial or taking an investigational drug Scheduled for living donor kidney transplant within the next 6 months Relocating to another dialysis unit within 6 months
Interventions	Intervention group CBT (TACcare or technology‐delivered health education) for 12 weeks Control group No intervention for 12 weeks Co‐interventions Not reported
Outcomes	Planned outcomes QoL Depression PHQ‐9: baseline and 12 weeks BDI‐II: baseline and 12 weeks Pain 10‐point VAS: baseline and 12 weeks BPI Short form: baseline and 12 weeks Fatigue 10‐point VAS: baseline and 12 weeks FACIT Fatigue: baseline and 12 weeks Inflammatory biomarker levels Adherence to fluid restriction: baseline, 3, 6 and 12 months Adherence to HD treatments: baseline, 3, 6 and 12 months Adherence to medications MAQ Morisky Green Levine: baseline, 3, 6 and 12 months Adverse events
Starting date	February 2018
Contact information	Manisha Jhamb Phone: 412‐647‐7062 Email: jhambm@upmc.edu
Notes	Trial Registeration Numbrer: NCT03440853. Funding: University of Pittsburgh. Recruitment status: recruiting