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NCT Number: NCT06978127

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNM, Albuquerque, New Mexico, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Eligibility Criteria:

  • age 18 years or older;
  • undergoing thrice-weekly maintenance hemodialysis (HD) for > 3 months;
  • English or Spanish speaking;
  • able to provide informed consent

Ineligibility Criteria:

  • active thought disorder, delusions or active suicidal ideation
  • active substance abuse
  • enrolled in hospice or life expectancy < 6 months (based on clinician's judgement)
  • too ill or cognitively impaired to participate based on renal provider's judgement
  • living kidney transplant scheduled in <3 months
  • undergoing active cancer treatment.
  • enrolled in another research study
  • plan to transition to home dialysis within 3 months
  • plan to move to another dialysis facility within 3 months

Treatment and study plan

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.

Usual Care Arm

Other

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

Primary outcomes

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

    Time frame: 6 months

    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.

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

    Time frame: 6 months

    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.

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

    Time frame: 6 months

    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.

Secondary outcomes

  1. Fatigue

    Time frame: 3 and 12 months

    Change in fatigue measured by The Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F). Scores range from 0-52 with lower scores indicating greater fatigue.

  2. Pain Intensity

    Time frame: 3 and 12 months

    Change in pain intensity measured by Brief Pain Inventory (BPI), which uses a scale of 0 to 10. Higher scores on the pain intensity scale indicate greater pain severity.

  3. Depression

    Time frame: 3 and 12 months

    Change in depression severity score using The Beck Depression Inventory-II (BDI-II). 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.

  4. Pain interference

    Time frame: 3, 6 and 12 months

    Brief Pain Inventory will be used to measure interference due to pain. Change in pain intensity measured by Brief Pain Inventory (BPI), which uses a scale of 0 to 10. Higher scores indicate worse pain interference.

  5. Dialysis Symptom Burden

    Time frame: 3, 6 and 12 months

    Dialysis symptom burden and severity will be assessed using the Dialysis Symptom Index (DSI). The total score can range from 0 to 150, with higher scores indicating a greater symptom burden.

  6. Self-Efficacy for Managing Chronic Conditions

    Time frame: 3, 6 and 12 months

    The Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions Short Form 8A will be used; higher scores indicate greater self-efficacy in managing chronic conditions.

  7. Sleep quality

    Time frame: 3, 6 and 12 months

    PROMIS Sleep Disturbance and sleep duration questions will be asked to assess sleep quality. The scale consists of 6 items with a 5-point response scale. Higher scores indicate greater sleep disturbance.

  8. Post Dialysis fatigue

    Time frame: 3, 6 and 12 months

    Single Item Question asking patients length of time it takes to recover from dialysis treatment will be used to assess post dialysis fatigue. Higher recovery time indicates greater post dialysis fatigue

  9. Anxiety

    Time frame: 3, 6 and 12 months

    The Generalized Anxiety Disorder 7-item (GAD-7) scale will be used to assess severity of anxiety symptoms. Scores range from 0 to 21 with higher scores indicating greater anxiety.

  10. Health related quality of life

    Time frame: 3, 6 and 12 months

    RAND 36-Item Short Form Health Survey (SF-36) will be used to measure health related quality-of-life measures. Scores range from 0 to 100 with higher scores indicating better health status.

  11. Perceived Social Support

    Time frame: 3, 6 and 12 months

    The Multi-Dimensional Scale of Perceived Social Support (MSPSS) will be used to assess patients' perceived level of social support. It is a 12 item measure that uses a 5-point Likert scale with higher scores indicating greater perceived social support.

  12. Adherence to dialysis treatments

    Time frame: 3, 6 and 12 months

    Data on missed dialysis treatments will be recorded from dialysis electronic health record

  13. Hospitalization/ER visits

    Time frame: 3, 6 and 12 months

    Data on hospitalizations and ER visits will be collected from the dialysis electronic health records

Other outcomes

  1. Fatigue Assessment Scale

    Time frame: Every 4 weeks during 12 week intervention

    The Fatigue Assessment Scale (FAS) is scored by summing up the responses to each of its 10 items, where each item is rated on a 5-point Likert scale from "never" (1) to "always" (5), resulting in a total score ranging from 10 (minimal fatigue) to 50 (extreme fatigue) ; higher scores indicate greater fatigue severity.

  2. PROMIS Anxiety SF 8A

    Time frame: Every 4 weeks during 12 week intervention

    The PROMIS Anxiety SF 8A is scored by summing up the responses to each of the 8 questions, where each question is rated on a 5-point scale (1=never to 5=always), resulting in a raw score; this raw score is then converted into a T-score using a reference table to provide a standardized measure of anxiety severity, with a mean T-score of 50 and a standard deviation of 10 across the general population.

  3. PROMIS Depression SF 8A

    Time frame: Every 4 weeks during 12 week intervention

    The PROMIS Depression SF 8A is scored by summing up the responses to each of the 8 questions, where each question is rated on a 5-point scale from 1 ("Never") to 5 ("Always"), resulting in a raw score; this raw score is then converted into a T-score using a provided table to interpret the severity of depression, with higher T-scores indicating greater depression severity.

  4. Visual Analog Scale (VAS) for Pain

    Time frame: Every 4 weeks during 12 week intervention

    A Visual Analog Scale (VAS) for pain is a simple pain measurement tool where a patient marks a point on a 10cm line to indicate the intensity of their pain, with one end representing "no pain" and the other end representing "worst pain imaginable"; the score is determined by measuring the distance from the "no pain" end to the mark made by the patient, usually in centimeters, providing a numerical value representing their pain level

Study contacts

Contact information is provided by the study sponsor or research team.

Manisha Jhamb, MD, MPH

CONTACT

[email protected]

412-647-7062

Mark Unruh, MD, MS

CONTACT

[email protected]

(505) 272-0407

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of New Mexico

Registry information

Official study title

Technology Assisted Collaborative Care Intervention (TĀCcare) 2.0 Implementation Trial to Improve Patient-centered Outcomes in Patients on Hemodialysis

Acronym: TACcare 2 0

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
May 18, 2025
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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