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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01DK114085-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| University of New Mexico | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Technology Assisted Stepped Collaborative Care Group | Active Comparator | 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. |
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| Usual Care Group | Active Comparator | Participants in the Usual Care Group will continue with their usual care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| 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. | 6 months |
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 and 12 months |
| Pain Intensity |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Assessment Scale | 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. | Every 4 weeks during 12 week intervention |
Eligibility Criteria:
Ineligibility Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manisha Jhamb, MD, MPH | Contact | 412-647-7062 | jhambm@upmc.edu | |
| Mark Unruh, MD, MS | Contact | (505) 272-0407 | MLUnruh@salud.unm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Manisha Jhamb, MD, MPH | University of Pittsburgh | Principal Investigator |
| Mark L Unruh, MS, MS | University of New Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNM | Recruiting | Albuquerque | New Mexico | 87131 | United States |
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.
Baseline data (defined as any data collected prior to any intervention), such as demographics, tabular clinical data will be submitted within 4 months after enrollment is completed and released through the repositories 4 months after that. After the study is complete and unblinded, the study team will submit all remaining scientific data to the data repositories and will update the RCT status to "complete" in clinicaltrials.gov. This data will be released 12 months after the end of the study. Under the current repository policies, data will be preserved and available for the wider research community in perpetuity.
To maximize the appropriate sharing of scientific data and protect research participants' privacy and confidentiality, reuse of this dataset should use the following Data Use Limitations (DULs) under Controlled Access that is made available by a data repository only after approval of the request by the repository's independent review panel process.
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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.
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| Usual Care Arm | Other | Participants in the Usual Care Arm will continue with their usual care. |
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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 and 12 months |
| 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. | 3 and 12 months |
| 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. | 3, 6 and 12 months |
| 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. | 3, 6 and 12 months |
| 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. | 3, 6 and 12 months |
| 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. | 3, 6 and 12 months |
| 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 | 3, 6 and 12 months |
| 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. | 3, 6 and 12 months |
| 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. | 3, 6 and 12 months |
| 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. | 3, 6 and 12 months |
| Adherence to dialysis treatments | Data on missed dialysis treatments will be recorded from dialysis electronic health record | 3, 6 and 12 months |
| Hospitalization/ER visits | Data on hospitalizations and ER visits will be collected from the dialysis electronic health records | 3, 6 and 12 months |
| PROMIS Anxiety SF 8A | 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. | Every 4 weeks during 12 week intervention |
| PROMIS Depression SF 8A | 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. | Every 4 weeks during 12 week intervention |
| Visual Analog Scale (VAS) for Pain | 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 | Every 4 weeks during 12 week intervention |
| University of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D010146 | Pain |
| D003863 | Depression |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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