Technology Assisted Stepped Collaborative Care Intervention

Hemodialysis Clinical Trial

— TASCCI  

Official title:

Technology Assisted Stepped Collaborative Care Intervention (TASCCI) to Improve Patient-centered Outcomes in Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03440853
• Other study ID #: PRO17070630
• Secondary ID: 1R01DK114085-01
• Status: Completed
• Phase: N/A
• Start date: March 28, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 30, 2022
• Est. primary completion date: April 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Hemodialysis
• Kidney Failure, Chronic

Intervention

Behavioral:
• TASCCI
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.

Other:
• Technology 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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To explore effect of TASCCI (hs-CRP, IL-6, IL-10 and TNF-a) on biomarkers of inflammation	Effect of intervention on biomarkers of inflammation be measured by improvements in inflammatory cytokines.	Baseline and Post 12 week intervention, 6 month
Primary	Change in depression from baseline to 12 weeks	Depressive symptoms will be measured using the Beck Depression Inventory-II	Baseline and Post 12 week intervention
Primary	Change in pain from baseline to 12 weeks	Pain symptoms will be measured using the Brief Pain Inventory	Baseline and Post 12 week intervention
Primary	Change in fatigue from baseline to 12 weeks	Fatigue symptoms will be measured using the FACIT-F	Baseline and Post 12 week intervention
Secondary	Change in adherence to medications	Adherence will be measured using the Medication Adherence Questionnaire (MAQ) Morisky Green Levine	Baseline, 3 month, 6 month, 12 month
Secondary	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	Baseline, 3 month, 6 month, 12 month
Secondary	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.	Baseline and Post 12 week intervention