Clinical trial NCT03440853: Technology Assisted Stepped Collaborative Care Intervention
Official title: Technology Assisted Stepped Collaborative Care Intervention (TASCCI) to Improve Patient-centered Outcomes in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-Stage Renal Disease
Hemodialysis
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of New Mexico
First posted: 2018-02-22
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in depression from baseline to 12 weeks
timeFrame: Baseline and Post 12 week intervention
measure: Change in pain from baseline to 12 weeks
timeFrame: Baseline and Post 12 week intervention
measure: Change in fatigue from baseline to 12 weeks
timeFrame: Baseline and Post 12 week intervention
Secondary outcomes:
measure: Change in adherence to medications
timeFrame: Baseline, 3 month, 6 month, 12 month
measure: Change in adherence to fluid restriction
timeFrame: Baseline, 3 month, 6 month, 12 month
measure: Change in adherence to hemodialysis treatments
timeFrame: Baseline and Post 12 week intervention
Other outcomes:
measure: To explore effect of TASCCI (hs-CRP, IL-6, IL-10 and TNF-α) on biomarkers of inflammation
timeFrame: Baseline and Post 12 week intervention, 6 month
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Manisha Jhamb, MD
role: PRINCIPAL_INVESTIGATOR
References: