Menu
Recruiting NCT06978127

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

No phase Interventional Chronic Kidney Disease Requiring Hemodialysis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Technology Assisted Stepped Collaborative Care, Usual Care Arm.
Who it may be relevant to
Registry conditions: Chronic Kidney Disease Requiring Hemodialysis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral 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 wil
  • Other Usual Care Arm
    Participants in the Usual Care Arm will continue with their usual care.

Primary outcome measures

  • TĀCcare 2.0 Effectiveness evaluation/Change in fatigue (co-primary outcome) [Time frame: 6 months]
  • TĀCcare 2.0 Effectiveness evaluation/Change in Pain Intensity (co-primary outcome) [Time frame: 6 months]
  • TĀCcare 2.0 Effectiveness evaluation/Change in Depression (co-primary outcome) [Time frame: 6 months]
Secondary outcome measures (12)
  • Fatigue [Time frame: 3 and 12 months]
  • Pain Intensity [Time frame: 3 and 12 months]
  • Depression [Time frame: 3 and 12 months]
  • Pain interference [Time frame: 3, 6 and 12 months]
  • Dialysis Symptom Burden [Time frame: 3, 6 and 12 months]
  • Self-Efficacy for Managing Chronic Conditions [Time frame: 3, 6 and 12 months]
  • Sleep quality [Time frame: 3, 6 and 12 months]
  • Post Dialysis fatigue [Time frame: 3, 6 and 12 months]
  • Anxiety [Time frame: 3, 6 and 12 months]
  • Health related quality of life [Time frame: 3, 6 and 12 months]
  • Perceived Social Support [Time frame: 3, 6 and 12 months]
  • Adherence to dialysis treatments [Time frame: 3, 6 and 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • UNM — Albuquerque
  • University of Pittsburgh — Pittsburgh

Identifiers

NCT: NCT06978127 · STUDY24070169 · 2R01DK114085-06

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗