End-Stage Renal Disease, Hemodialysis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALTASCCI
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.
OTHERTechnology Delivered Health Education Intervention
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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of New Mexico
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Patient reported outcomes will be administered centrally by blinded interviewers using computer-assisted telephone interviewing (CATI).
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years or older 2. undergoing thrice-weekly maintenance hemodialysis for \> 3 months 3. English speaking 4. able to provide informed consent 5. no evidence of thought disorder, delusions or active suicidal ideation
Exclusion criteria
1. thought disorder, delusions or active suicidal ideation 2. active substance abuse 3. too ill or cognitively impaired to participate based on clinicians' judgment 4. anticipated life expectancy of less than 1 year 5. unable or unwilling to adhere to study protocol 6. participating in another clinical trial or taking an investigational drug 7. scheduled for living donor kidney transplant within next 6 months 8. relocating to another dialysis unit within 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in fatigue from baseline to 12 weeks | Baseline and Post 12 week intervention | Fatigue symptoms will be measured using the FACIT-F |
| Change in depression from baseline to 12 weeks | Baseline and Post 12 week intervention | Depressive symptoms will be measured using the Beck Depression Inventory-II |
| Change in pain from baseline to 12 weeks | Baseline and Post 12 week intervention | Pain symptoms will be measured using the Brief Pain Inventory |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in adherence to hemodialysis treatments | Baseline and Post 12 week intervention | 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. |
| Change in adherence to medications | Baseline, 3 month, 6 month, 12 month | Adherence will be measured using the Medication Adherence Questionnaire (MAQ) Morisky Green Levine |
| Change in adherence to fluid restriction | Baseline, 3 month, 6 month, 12 month | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| To explore effect of TASCCI (hs-CRP, IL-6, IL-10 and TNF-α) on biomarkers of inflammation | Baseline and Post 12 week intervention, 6 month | Effect of intervention on biomarkers of inflammation be measured by improvements in inflammatory cytokines. |
Countries
United States
Outcome results
None listed