An interventional study of TASCCI and Technology Delivered Health Education Intervention in End-Stage Renal Disease and Hemodialysis, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-11.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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.
Behavioral: TASCCI
Patients randomized to the Technology Delivered Health Education Intervention health education group will receive technology delivered health education material on topics relevant to dialysis.
Other: Technology Delivered Health Education Intervention
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.
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.
Change in depression from baseline to 12 weeks
Depressive symptoms will be measured using the Beck Depression Inventory-II
Time frame: Baseline and Post 12 week intervention
Change in pain from baseline to 12 weeks
Pain symptoms will be measured using the Brief Pain Inventory
Time frame: Baseline and Post 12 week intervention
Change in fatigue from baseline to 12 weeks
Fatigue symptoms will be measured using the FACIT-F
Time frame: Baseline and Post 12 week intervention
Change in adherence to medications
Adherence will be measured using the Medication Adherence Questionnaire (MAQ) Morisky Green Levine
Time frame: Baseline, 3 month, 6 month, 12 month
Change in adherence to fluid restriction
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
Time frame: 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.
Time frame: Baseline and Post 12 week intervention
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.
Time frame: Baseline and Post 12 week intervention, 6 month
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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University of Pittsburgh