Technology Assisted Stepped Collaborative Care Intervention

Not Applicable

Completed

• Conditions: End-Stage Renal Disease; Hemodialysis

• 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.

Study Timeline

• Study First Submitted: 2018-01-31
• Study First Submitted QC: 2018-02-19
• Study First Posted: 2018-02-22
• Study Start: 2018-03-28
• Primary Completion: 2022-04-29
• Study Completion: 2022-06-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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