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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• TĀCcare 2.0 Effectiveness evaluation/Change in fatigue (co-primary outcome) [Срок оценки: 6 months]
• TĀCcare 2.0 Effectiveness evaluation/Change in Pain Intensity (co-primary outcome) [Срок оценки: 6 months]
• TĀCcare 2.0 Effectiveness evaluation/Change in Depression (co-primary outcome) [Срок оценки: 6 months]

Вторичные конечные точки (12)

• Fatigue [Срок оценки: 3 and 12 months]
• Pain Intensity [Срок оценки: 3 and 12 months]
• Depression [Срок оценки: 3 and 12 months]
• Pain interference [Срок оценки: 3, 6 and 12 months]
• Dialysis Symptom Burden [Срок оценки: 3, 6 and 12 months]
• Self-Efficacy for Managing Chronic Conditions [Срок оценки: 3, 6 and 12 months]
• Sleep quality [Срок оценки: 3, 6 and 12 months]
• Post Dialysis fatigue [Срок оценки: 3, 6 and 12 months]
• Anxiety [Срок оценки: 3, 6 and 12 months]
• Health related quality of life [Срок оценки: 3, 6 and 12 months]
• Perceived Social Support [Срок оценки: 3, 6 and 12 months]
• Adherence to dialysis treatments [Срок оценки: 3, 6 and 12 months]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• UNM — Albuquerque
• University of Pittsburgh — Pittsburgh

Идентификаторы

NCT: NCT06978127 · STUDY24070169 · 2R01DK114085-06

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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