Technology Assisted Stepped Collaborative Care Intervention
- Conditions
- End-Stage Renal DiseaseHemodialysis
- Interventions
- Other: Technology Delivered Health Education InterventionBehavioral: TASCCI
- Registration Number
- NCT03440853
- Lead Sponsor
- University of Pittsburgh
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- 18 years or older
- undergoing thrice-weekly maintenance hemodialysis for > 3 months
- English speaking
- able to provide informed consent
- no evidence of thought disorder, delusions or active suicidal ideation
- thought disorder, delusions or active suicidal ideation
- active substance abuse
- too ill or cognitively impaired to participate based on clinicians' judgment
- anticipated life expectancy of less than 1 year
- unable or unwilling to adhere to study protocol
- participating in another clinical trial or taking an investigational drug
- scheduled for living donor kidney transplant within next 6 months
- relocating to another dialysis unit within 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Technology Delivered Health Education Technology Delivered Health Education Intervention Patients randomized to the Technology Delivered Health Education Intervention health education group will receive technology delivered health education material on topics relevant to dialysis. TASCCI TASCCI 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.
- Primary Outcome Measures
Name Time Method Change in pain from baseline to 12 weeks Baseline and Post 12 week intervention Pain symptoms will be measured using the Brief Pain Inventory
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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States