Technology Assisted Stepped Collaborative Care Intervention

NCT03440853 | Completed DMC

• 2 other identifiers: PRO170706301R01DK114085-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

End-Stage Renal Disease; Hemodialysis

Outcome Measures

Primary Outcomes (3)

• 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

• Change in pain from baseline to 12 weeks

  Pain symptoms will be measured using the Brief Pain Inventory

  Baseline and Post 12 week intervention

• Change in fatigue from baseline to 12 weeks

  Fatigue symptoms will be measured using the FACIT-F

  Baseline and Post 12 week intervention

Secondary Outcomes (3)

• 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

• Change in adherence to hemodialysis treatments

  Baseline and Post 12 week intervention

Other Outcomes (1)

• To explore effect of TASCCI (hs-CRP, IL-6, IL-10 and TNF-α) on biomarkers of inflammation

  Baseline and Post 12 week intervention, 6 month

Study Arms (2)

TASCCI

EXPERIMENTAL

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.

Behavioral: TASCCI

Technology Delivered Health Education

OTHER

Patients randomized to the Technology Delivered Health Education Intervention health education group will receive technology delivered health education material on topics relevant to dialysis.

Other: Technology Delivered Health Education Intervention

Interventions

TASCCI BEHAVIORAL

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.

TASCCI

Technology Delivered Health Education Intervention OTHER

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.

Technology Delivered Health Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of New Mexico: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Jhamb M, Steel JL, Yabes JG, Roumelioti ME, Erickson S, Devaraj SM, Vowles KE, Vodovotz Y, Beach S, Weisbord SD, Rollman BL, Unruh M. Effects of Technology Assisted Stepped Collaborative Care Intervention to Improve Symptoms in Patients Undergoing Hemodialysis: The TACcare Randomized Clinical Trial. JAMA Intern Med. 2023 Aug 1;183(8):795-805. doi: 10.1001/jamainternmed.2023.2215.

  PMID: 37338898 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Manisha Jhamb, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patient reported outcomes will be administered centrally by blinded interviewers using computer-assisted telephone interviewing (CATI).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 22, 2018
• Study Start: March 28, 2018
• Primary Completion: April 29, 2022
• Study Completion: June 30, 2022
• Last Updated: July 11, 2022

Record last verified: 2022-07

Locations

US (1)