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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a combination of medication and talk therapy, called Technology Assisted Stepped Collaborative Care, can reduce pain, fatigue, and depression in people with chronic kidney disease. Participants will either receive this specialized care or continue their usual treatments to determine which is more effective. It suits individuals who have been on regular dialysis for over three months and speak English or Spanish. As an unphased trial, this study provides a unique opportunity to contribute to innovative care approaches for chronic kidney disease.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this collaborative care intervention is safe?

Research has shown that the Technology Assisted Stepped Collaborative Care treatment helps manage fatigue and pain in patients undergoing long-term hemodialysis. Patients generally tolerated the treatment well, indicating its safety. Previous studies did not report any major side effects, suggesting it did not cause serious problems for participants. While this is encouraging, each person’s experience can differ. Always consult a healthcare provider about the possible risks and benefits before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Technology Assisted Stepped Collaborative Care for chronic kidney disease because it combines technology with personalized treatment strategies to tackle symptoms like fatigue, pain, and depression. Unlike standard care, which typically involves a one-size-fits-all approach, this method uses a stepped care model that tailors both medication and Cognitive Behavioral Therapy (CBT) to each individual's needs. This personalized approach in a real-world setting aims to improve patient outcomes by addressing multiple symptoms simultaneously, providing a more comprehensive and flexible treatment plan.

What evidence suggests that Technology Assisted Stepped Collaborative Care is effective for improving symptoms of fatigue, pain, and depression?

Research has shown that Technology Assisted Stepped Collaborative Care, which participants in this trial may receive, can help reduce symptoms like tiredness and pain for patients on long-term hemodialysis. One study found that this care approach significantly improved these symptoms. Another clinical trial reported modest improvements in patients' conditions using this method during hemodialysis. This type of care combines medication management and cognitive behavioral therapy (a type of talk therapy) to address specific symptoms, showing promise in managing depression, pain, and fatigue. Overall, evidence suggests this approach may improve the quality of life for patients with chronic kidney disease. ^{1 2 3 5 6}

Who Is on the Research Team?

Manisha Jhamb, MD, MPH

Principal Investigator

University of Pittsburgh

Mark L Unruh, MS, MS

Principal Investigator

University of New Mexico

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10282960/

Effects of Technology Assisted Stepped Collaborative Care ... This stepped collaborative care intervention is a significantly effective treatment for fatigue and pain in patients undergoing long-term hemodialysis for ESKD.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03440853

Study Details | NCT03440853 | Technology Assisted ... This study will look at the effect of a 12 week stepped care intervention on changes in depression, pain or fatigue and health related quality of life. Official ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37338898/

The TĀCcare Randomized Clinical Trial - PubMed - NIH This randomized clinical trial found that a technology assisted stepped collaborative care intervention delivered during hemodialysis led to modest but ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1551714418302921

Rationale and design of technology assisted stepped ... TĀCcare is the first, large multi-center randomized controlled trial to test the efficacy of a stepped-collaborative care intervention targeting symptom ...

5. ctv.veeva.com ctv.veeva.com/study/technology-assisted-collaborative-care-intervention-to-improve-patient-centered-outcomes-in-dialysis

Technology Assisted Collaborative Care Intervention to ... The goal of this study is to conduct a hybrid Type II effectiveness-implementation, cluster randomized trial of TĀCcare 2.0 facilitated by ...

6. frontiersin.org frontiersin.org/journals/nephrology/articles/10.3389/fneph.2023.1148565/full

as a case illustration, the Withings toolkit health sensing tools In this narrative essay, we analyze the clinical potential of pervasive wearable sensors for monitoring ambulatory dialysis patients.