Technology Assisted Collaborative Care Intervention to Improve Patient-centered Outcomes in Dialysis Patients

NCT06978127 | Recruiting DMC

• 2 other identifiers: STUDY240701692R01DK114085-06
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Kidney Disease Requiring Hemodialysis

Keywords

Chronic Kidney Disease; Hemodialysis; Pain; Depression; Fatigue

Outcome Measures

Primary Outcomes (3)

• TĀCcare 2.0 Effectiveness evaluation/Change in fatigue (co-primary outcome)

  Change in fatigue is a primary outcome. The Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) will be used to measure fatigue. Scores range from 0-52 with lower scores indicating greater fatigue.

  6 months

• TĀCcare 2.0 Effectiveness evaluation/Change in Pain Intensity (co-primary outcome)

  Change in pain intensity score is also a primary outcome measure. The Brief Pain Inventory (BPI) will be used to measure pain intensity. The BPI uses a scale of 0 to 10. Higher scores on the pain intensity scale indicate greater pain severity.

  6 months

• TĀCcare 2.0 Effectiveness evaluation/Change in Depression (co-primary outcome)

  Change in depression severity score is also a primary outcome measure. The Beck Depression Inventory-II will be used to measure the depression severity score. Each item is scored on a 4 point scale ranging from 0 to 3, allowing for a total score ranging from 0 to 63. Higher scores indicate more severe symptoms.

  6 months

Secondary Outcomes (13)

• Fatigue

  3 and 12 months

• Pain Intensity

  3 and 12 months

• Depression

  3 and 12 months

• Pain interference

  3, 6 and 12 months

• Dialysis Symptom Burden

  3, 6 and 12 months

Other Outcomes (4)

• Fatigue Assessment Scale

  Every 4 weeks during 12 week intervention

• PROMIS Anxiety SF 8A

  Every 4 weeks during 12 week intervention

• PROMIS Depression SF 8A

  Every 4 weeks during 12 week intervention

Study Arms (2)

Technology Assisted Stepped Collaborative Care Group

ACTIVE COMPARATOR

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.

Behavioral: Technology Assisted Stepped Collaborative Care

Usual Care Group

ACTIVE COMPARATOR

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

Other: Usual Care Arm

Interventions

Technology Assisted Stepped Collaborative Care BEHAVIORAL

The TĀCcare 2.0 intervention will provide pharmacotherapy recommendations and/or CBT for pain, fatigue and depression. A stepped-treatment approach will be used to intensify treatment. CBT will be provided through 12 weekly telehealth sessions (done during dialysis treatment or from home) with the behavioral specialist. Booster sessions will be used to enhance the maintenance of effect following the initial intervention to complete a total 12 month intervention. A collaborative care approach will be used so that patients' symptom management will be integrated with their dialysis treatment. Throughout the study, participants will be asked to complete phone surveys about their symptoms and health.

Technology Assisted Stepped Collaborative Care Group

Usual Care Arm OTHER

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

Usual Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of New Mexico: collaborator
• University of Pittsburgh: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

UNM

Albuquerque, New Mexico, 87131, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Pain; Depression; Fatigue

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Manisha Jhamb, MD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Mark L Unruh, MS, MS

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manisha Jhamb, MD, MPH

CONTACT

412-647-7062; jhambm@upmc.edu

Mark Unruh, MD, MS

CONTACT

(505) 272-0407; MLUnruh@salud.unm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: The intervention is a hybrid Type II effectiveness-implementation, cluster randomized trial of TĀCcare 2.0 facilitated by dialysis staff in a real-world setting.

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 18, 2025
• Study Start: August 28, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: February 2, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Baseline data (defined as any data collected prior to any intervention), such as demographics, tabular clinical data will be submitted within 4 months after enrollment is completed and released through the repositories 4 months after that. After the study is complete and unblinded, the study team will submit all remaining scientific data to the data repositories and will update the RCT status to "complete" in clinicaltrials.gov. This data will be released 12 months after the end of the study. Under the current repository policies, data will be preserved and available for the wider research community in perpetuity.
• Access Criteria: To maximize the appropriate sharing of scientific data and protect research participants' privacy and confidentiality, reuse of this dataset should use the following Data Use Limitations (DULs) under Controlled Access that is made available by a data repository only after approval of the request by the repository's independent review panel process.

Locations

US (2)