Chronic Kidney Disease Requiring Hemodialysis
Conditions
Keywords
Chronic Kidney Disease, Hemodialysis, Pain, Depression, Fatigue
Brief 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.
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
BEHAVIORALTechnology 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 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.
OTHERUsual Care Arm
Participants in the Usual Care Arm will continue with their usual care.
Sponsors
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TĀCcare 2.0 Effectiveness evaluation/Change in fatigue (co-primary outcome) | 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. |
| TĀCcare 2.0 Effectiveness evaluation/Change in Pain Intensity (co-primary outcome) | 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. |
| TĀCcare 2.0 Effectiveness evaluation/Change in Depression (co-primary outcome) | 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
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | 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. |
| Pain Intensity | 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. |
| Depression | 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. |
| Pain interference | 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. |
| Dialysis Symptom Burden | 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. |
| Self-Efficacy for Managing Chronic Conditions | 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. |
| Sleep quality | 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. |
| Post Dialysis fatigue | 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 |
| Anxiety | 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. |
| Health related quality of life | 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. |
| Perceived Social Support | 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. |
| Adherence to dialysis treatments | 3, 6 and 12 months | Data on missed dialysis treatments will be recorded from dialysis electronic health record |
| Hospitalization/ER visits | 3, 6 and 12 months | Data on hospitalizations and ER visits will be collected from the dialysis electronic health records |
Countries
United States
Contacts
CONTACTManisha Jhamb, MD, MPH
CONTACTMark Unruh, MD, MS
PRINCIPAL_INVESTIGATORManisha Jhamb, MD, MPH
University of Pittsburgh
PRINCIPAL_INVESTIGATORMark L Unruh, MS, MS
University of New Mexico
Outcome results
None listed