Clinical trial NCT06978127: Technology Assisted Collaborative Care Intervention to Improve Patient-centered Outcomes in Dialysis Patients
Official title: Technology Assisted Collaborative Care Intervention (TĀCcare) 2.0 Implementation Trial to Improve Patient-centered Outcomes in Patients on Hemodialysis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease Requiring Hemodialysis
Keywords: Chronic Kidney Disease
Hemodialysis
Pain
Depression
Fatigue
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of New Mexico
First posted: 2025-05-18
Enrollment: 424
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: The goal of this study is to conduct a hybrid Type II effectiveness-implementation, cluster randomized trial of TĀCcare 2.0 facilitated by dialysis staff in a real-world setting. This is a multi-center, dialysis-clinic level cluster randomized trial of 424 patients from 36 dialysis clinics comparing TACcare 2.0 facilitated by dialysis staff versus usual care. Patients' dialysis clinic will be placed randomly into one of two study groups: the Technology Assisted Stepped Collaborative Care Intervention Group or the Usual Care Group.

The intervention will target three of the most debilitating End State Kidney Disease (ESKD) related symptoms- fatigue, pain and depression. A stepped collaborative care approach for pharmaco and/or CBT allows for shared decision-making and individualization of treatment according to a patient's clinical status, preferences and treatment response. The TĀCcare 2.0 intervention will build on successful design elements of the original intervention, enhance depression management strategies and increase durability of effect by incorporating monthly longitudinal telemedicine-delivered booster sessions to complete a total 12-month intervention. Additionally, using a collaborative care approach, the patients' symptom management will be integrated with their dialysis treatment, thus increasing patient acceptability and adherence.

Eligibility criteria: 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

Primary outcomes:
measure: TĀCcare 2.0 Effectiveness evaluation/Change in fatigue (co-primary outcome)
timeFrame: 6 months
measure: TĀCcare 2.0 Effectiveness evaluation/Change in Pain Intensity (co-primary outcome)
timeFrame: 6 months
measure: TĀCcare 2.0 Effectiveness evaluation/Change in Depression (co-primary outcome)
timeFrame: 6 months
Secondary outcomes:
measure: Fatigue
timeFrame: 3 and 12 months
measure: Pain Intensity
timeFrame: 3 and 12 months
measure: Depression
timeFrame: 3 and 12 months
measure: Pain interference
timeFrame: 3, 6 and 12 months
measure: Dialysis Symptom Burden
timeFrame: 3, 6 and 12 months
measure: Self-Efficacy for Managing Chronic Conditions
timeFrame: 3, 6 and 12 months
measure: Sleep quality
timeFrame: 3, 6 and 12 months
measure: Post Dialysis fatigue
timeFrame: 3, 6 and 12 months
measure: Anxiety
timeFrame: 3, 6 and 12 months
measure: Health related quality of life
timeFrame: 3, 6 and 12 months
measure: Perceived Social Support
timeFrame: 3, 6 and 12 months
measure: Adherence to dialysis treatments
timeFrame: 3, 6 and 12 months
measure: Hospitalization/ER visits
timeFrame: 3, 6 and 12 months
Other outcomes:
measure: Fatigue Assessment Scale
timeFrame: Every 4 weeks during 12 week intervention
measure: PROMIS Anxiety SF 8A
timeFrame: Every 4 weeks during 12 week intervention
measure: PROMIS Depression SF 8A
timeFrame: Every 4 weeks during 12 week intervention
measure: Visual Analog Scale (VAS) for Pain
timeFrame: Every 4 weeks during 12 week intervention
Locations:
city: Albuquerque
country: United States
facility: UNM
state: New Mexico
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Manisha Jhamb, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of New Mexico
name: Mark L Unruh, MS, MS
role: PRINCIPAL_INVESTIGATOR
References: