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Chronic Kidney Disease Requiring HemodialysisTACcare 2 0NCT06978127

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

A study testing Technology Assisted Stepped Collaborative Care in people with Chronic Kidney Disease Requiring Hemodialysis, run by University of Pittsburgh at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Technology Assisted Stepped Collaborative Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
424 participants
Where
2 sitesUnited States
Study dates
28 Aug 2025to 30 Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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 locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Manisha Jhamb, MD, MPH contact

412-647-7062

jhambm@upmc.edu

Mark Unruh, MD, MS contact

(505) 272-0407

MLUnruh@salud.unm.edu

United States2 sites, 2 recruiting

  • UNM

    Albuquerque, New Mexico, 87131

    Mark Unruh, MD, (505) 272-0407, MLUnruh@salud.unm.edu

    Recruiting

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

    Melissa Weimer, MS, 412-802-6739, mew97@pitt.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Technology Assisted Stepped Collaborative Care, Usual Care Arm
Keywords
Chronic Kidney Disease, Hemodialysis, Pain, Depression, Fatigue
Medical subject headings
Renal Insufficiency, Chronic, Pain, Depression, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Technology Assisted Stepped Collaborative CareBehavioural

    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 ArmOther

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

Study groups in NCT06978127
Study groupRoleWhat they receive
Technology Assisted Stepped Collaborative Care GroupActive comparatorParticipants 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.
Receives: Behavioral: Technology Assisted Stepped Collaborative Care
Usual Care GroupActive comparatorParticipants in the Usual Care Group will continue with their usual care.
Receives: Other: Usual Care Arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 6 months

  3. 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.

    Measured: 6 months

Secondary outcomes (13)

  1. Fatigue

    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.

    Measured: 3 and 12 months

  2. Pain Intensity

    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.

    Measured: 3 and 12 months

  3. Depression

    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.

    Measured: 3 and 12 months

  4. Pain interference

    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.

    Measured: 3, 6 and 12 months

  5. Dialysis Symptom Burden

    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.

    Measured: 3, 6 and 12 months

  6. Self-Efficacy for Managing Chronic Conditions

    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.

    Measured: 3, 6 and 12 months

  7. Sleep quality

    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.

    Measured: 3, 6 and 12 months

  8. Post Dialysis fatigue

    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

    Measured: 3, 6 and 12 months

  9. Anxiety

    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.

    Measured: 3, 6 and 12 months

  10. Health related quality of life

    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.

    Measured: 3, 6 and 12 months

  11. Perceived Social Support

    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.

    Measured: 3, 6 and 12 months

  12. Adherence to dialysis treatments

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

    Measured: 3, 6 and 12 months

  13. Hospitalization/ER visits

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

    Measured: 3, 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2025
  2. Study start28 Aug 2025
  3. Primary completion30 Jun 2029 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
424 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06978127
Sponsor's protocol ID
STUDY24070169
Other IDs
2R01DK114085-06
Acronym
TACcare 2 0
Status last verified
Aug 2026
First submitted
30 Apr 2025
Last updated
24 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All subject-level clinical, survey, and laboratory will be preserved and shared. Data will be deidentified before submission. The study protocol, date collection forms/case report forms, data dictionary, manual of operations, interview guides, qualitative analysis codebook and a glossary of domain-specific terms will be submitted.

Questions about this trial

What is this clinical trial studying?

A study testing Technology Assisted Stepped Collaborative Care in people with Chronic Kidney Disease Requiring Hemodialysis, run by University of Pittsburgh at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Manisha Jhamb, MD, MPH (412-647-7062, jhambm@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TĀCcare 2.0 Effectiveness evaluation/Change in fatigue (co-primary outcome) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06978127.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.

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