Technology Assisted Collaborative Care for Chronic Kidney Disease

(TACcare 2 0 Trial)

Recruiting at 1 trial location

Overseen By Manisha Jhamb, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Thought disorder, Substance abuse, Hospice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

424 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Mark L Unruh, MS, MS

Principal Investigator

University of New Mexico

Manisha Jhamb, MD, MPH

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for dialysis patients with renal disease, contrast-induced nephropathy, or chronic kidney disease who are experiencing symptoms of pain, fatigue, or depression. Specific eligibility criteria details were not provided.

Inclusion Criteria

I have been on hemodialysis 3 times a week for over 3 months.

Able to provide informed consent

Exclusion Criteria

Active substance abuse

Enrolled in hospice or life expectancy less than 6 months (based on clinician's judgement)

My doctor thinks I'm too sick or not mentally sharp enough for this study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the TĀCcare 2.0 intervention, which includes pharmaco-therapy and/or cognitive behavioral therapy (CBT) integrated with dialysis treatment, for 12 months

12 months

Monthly telemedicine-delivered booster sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Technology Assisted Stepped Collaborative Care

Trial Overview The study tests a collaborative care approach using medication and/or cognitive behavioral therapy (CBT) against usual care to see if it betters patient outcomes related to pain, fatigue, and depression in a real-world setting.

Participant Groups

Group I: Technology Assisted Stepped Collaborative Care Group Active Control 1 Intervention

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.

Group II: Usual Care Group Active Control 1 Intervention

Participants in the Usual Care Group will continue with their usual care.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

University of New Mexico

Collaborator

Trials

393

Recruited

3,526,000+