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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK114085-01 | 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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This study evaluates a collaborative care intervention in reducing depression, fatigue and pain symptoms and improving health related quality of life in hemodialysis patients. Half of participants will receive the collaborative care intervention, while the other half will receive technology delivered health education information.
End-stage renal disease patients on hemodialysis experience substantial symptom burden with fatigue, pain and depression among the most debilitating and existing as symptom clusters. These symptom clusters can exacerbate one another, and are independent and strong predictors of poor health-related quality of life in hemodialysis patients. This study will look at the effect of a 12 week stepped care intervention on changes in depression, pain or fatigue and health related quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TASCCI | Experimental | Patients randomized to TASCCI will receive a stepped-care approach of pharmaco and/or behavioral therapy for 12 weeks. The intervention will target 1 or more symptoms based on patients' report of clinical levels of each symptom and patient preference. |
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| Technology Delivered Health Education | Other | Patients randomized to the Technology Delivered Health Education Intervention health education group will receive technology delivered health education material on topics relevant to dialysis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TASCCI | Behavioral | TASCCI is a stepped-care collaborative care approach of pharmaco- and/or behavioral-therapy for a 12 week period. The intervention will target 1 or more symptoms based on patients' report of clinical levels of each symptom and patient preference. A trained behavioral therapist will deliver weekly video conferencing sessions during dialysis treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in depression from baseline to 12 weeks | Depressive symptoms will be measured using the Beck Depression Inventory-II | Baseline and Post 12 week intervention |
| Change in pain from baseline to 12 weeks | Pain symptoms will be measured using the Brief Pain Inventory | Baseline and Post 12 week intervention |
| Change in fatigue from baseline to 12 weeks | Fatigue symptoms will be measured using the FACIT-F | Baseline and Post 12 week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in adherence to medications | Adherence will be measured using the Medication Adherence Questionnaire (MAQ) Morisky Green Levine | Baseline, 3 month, 6 month, 12 month |
| Change in adherence to fluid restriction |
| Measure | Description | Time Frame |
|---|---|---|
| To explore effect of TASCCI (hs-CRP, IL-6, IL-10 and TNF-α) on biomarkers of inflammation | Effect of intervention on biomarkers of inflammation be measured by improvements in inflammatory cytokines. | Baseline and Post 12 week intervention, 6 month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manisha Jhamb, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38704664 | Derived | Erickson SJ, Yabes JG, Han Z, Roumelioti ME, Rollman BL, Weisbord SD, Steel JL, Unruh ML, Jhamb M. Associations between Social Support and Patient-Reported Outcomes in Patients Receiving Hemodialysis: Results from the TACcare Study. Kidney360. 2024 Jun 1;5(6):860-869. doi: 10.34067/KID.0000000000000456. Epub 2024 May 3. | |
| 37338898 | Derived | Jhamb M, Steel JL, Yabes JG, Roumelioti ME, Erickson S, Devaraj SM, Vowles KE, Vodovotz Y, Beach S, Weisbord SD, Rollman BL, Unruh M. Effects of Technology Assisted Stepped Collaborative Care Intervention to Improve Symptoms in Patients Undergoing Hemodialysis: The TACcare Randomized Clinical Trial. JAMA Intern Med. 2023 Aug 1;183(8):795-805. doi: 10.1001/jamainternmed.2023.2215. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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Patients will be randomized 1:1 to TASCCI or technology-delivered health education and undergo a 12-week intervention. Psychological and clinical outcomes will be collected at baseline, post intervention, 6 and 12 months.
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Patient reported outcomes will be administered centrally by blinded interviewers using computer-assisted telephone interviewing (CATI).
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| Technology Delivered Health Education Intervention | Other | The Technology Delivered Health Education Intervention will deliver weekly video conferencing sessions to deliver online educational material from the National Kidney Foundation. These sessions will be delivered by a care coordinator. |
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Fluid restriction adherence will be determined by inter-dialytic weight gain percentage (of post dialysis weight over preceding 1 month) obtained by reviewing dialysis records. Those with IDWG% >3.5% will be classified as non-adherent
| Baseline, 3 month, 6 month, 12 month |
| Change in adherence to hemodialysis treatments | Non-adherence with dialysis will be defined by the percentage of all dialysis sessions skipped and/or requested by the patient to be shortened by ≥ 10 minutes over the 12 week intervention period. | Baseline and Post 12 week intervention |
| 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 |