Technology Assisted Collaborative Care Intervention to Improve Patient-centered Outcomes in Dialysis Patients
NCT ID: NCT06978127
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
424 participants
INTERVENTIONAL
2025-08-28
2029-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Technology Assisted Stepped Collaborative Care Group
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.
Technology Assisted Stepped Collaborative Care
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.
Usual Care Group
Participants in the Usual Care Group will continue with their usual care.
Usual Care Arm
Participants in the Usual Care Arm will continue with their usual care.
Interventions
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Technology Assisted Stepped Collaborative Care
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.
Usual Care Arm
Participants in the Usual Care Arm will continue with their usual care.
Eligibility Criteria
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Inclusion 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
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of New Mexico
OTHER
University of Pittsburgh
OTHER
Responsible Party
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Manisha Jhamb
Associate Professor of Medicine
Principal Investigators
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Manisha Jhamb, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Mark L Unruh, MS, MS
Role: PRINCIPAL_INVESTIGATOR
University of New Mexico
Locations
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UNM
Albuquerque, New Mexico, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY24070169
Identifier Type: -
Identifier Source: org_study_id
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