Technology Assisted Collaborative Care Intervention to Improve Patient-centered Outcomes in Dialysis Patients (TACcare 2 0)

University of Pittsburgh

Status: Enrolling

Conditions: Chronic Kidney Disease Requiring Hemodialysis

Treatments: Other: Usual Care Arm; Behavioral: Technology Assisted Stepped Collaborative Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06978127

2R01DK114085-06 (U.S. NIH Grant/Contract)

STUDY24070169

Details and patient eligibility

About

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.

Full 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.

Enrollment: 424 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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424 participants in 2 patient groups

Technology Assisted Stepped Collaborative Care Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Technology Assisted Stepped Collaborative Care

Usual Care Group

Active Comparator group

Description:

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

Treatment:

Other: Usual Care Arm