Technology Assisted Stepped Collaborative Care Intervention (TASCCI) to Improve Patient-centered Outcomes in Hemodialysis Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pittsburgh
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Change in pain from baseline to 12 weeks
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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).
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: TASCCI (Behavioral)
Technology Delivered Health Education
Patients randomized to the Technology Delivered Health Education Intervention health education group will receive technology delivered health education material on topics relevant to dialysis.
Intervention: Technology Delivered Health Education Intervention (Other)
Outcomes
Primary Outcomes
Change in pain from baseline to 12 weeks
Time Frame: Baseline and Post 12 week intervention
Pain symptoms will be measured using the Brief Pain Inventory
Change in fatigue from baseline to 12 weeks
Time Frame: Baseline and Post 12 week intervention
Fatigue symptoms will be measured using the FACIT-F
Change in depression from baseline to 12 weeks
Time Frame: Baseline and Post 12 week intervention
Depressive symptoms will be measured using the Beck Depression Inventory-II
Secondary Outcomes
- Change in adherence to hemodialysis treatments(Baseline and Post 12 week intervention)
- Change in adherence to medications(Baseline, 3 month, 6 month, 12 month)
- Change in adherence to fluid restriction(Baseline, 3 month, 6 month, 12 month)
Investigators
Manisha Jhamb
Associate Professor of Medicine
University of Pittsburgh