Collaborative Care Intervention for Chronic Kidney Disease
1 other identifier
interventional
10
1 country
1
Brief Summary
The aims of the present study will be to pilot test the efficacy of a collaborative care intervention in patients awaiting kidney transplant to reduce symptoms of depression, pain, fatigue and improve quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedFirst Posted
Study publicly available on registry
October 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedDecember 13, 2024
December 1, 2024
3.5 years
January 5, 2016
December 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Depression Level
score on CES-D questionnaire
change from baseline at 3 month and 6 month
Perceived Stress level
score on PSS questionnaire
change from baseline at 3 month and 6 month
degree of Pain
score on the BPI questionnaire
change from baseline at 3 month and 6 month
Secondary Outcomes (4)
Dyadic functioning
change from baseline at 3 month and 6 month
level of physical activity (mild, moderate or high)
change from baseline at 3 month and 6 month
sleep quality
change from baseline at 3 month and 6 month
quality of life
change from baseline at 3 month and 6 month
Study Arms (1)
collaborative care
EXPERIMENTALTo test the efficacy of a collaborative care intervention with patients treated with dialysis to reduce depression, pain, fatigue, and improve quality of life
Interventions
Therapist will use iPad (Vidyo) once a week during dialysis for approximately one hour. The therapist will teach the patient cognitive-behavioral strategies to manage their mood and pain. The PI is a clinical psychologist and will provide supervision to the therapist providing the intervention. The sessions for depression will include (1) intake, (2) review of the rational for using CBT to treat depression and/or pain, (3) identifying thought patterns, (4) changing thought patterns, (5) relaxation techniques, (6) rest-activity pacing, and (7) coping strategies. Homework to practice these techniques will be provided after each session.
Eligibility Criteria
You may qualify if:
- Age 18 or older Currently receiving dialysis at UPMC dialysis facility for chronic kidney disease Fluent in English
You may not qualify if:
- Under the age of 18 years or over 90 years Not fluent in English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (1)
Kallem CJ, Tevar AA, Bradley T, Jackson H, Haggerty D, Cheng H, Pathak R, Wang Y, Carney M, Gardner S, Deshpande A, Jhamb M, Steel JL. A phase II pilot randomized controlled trial of an integrated stepped collaborative care intervention for patients awaiting kidney transplantation (CARES-transplant). J Behav Med. 2025 Oct;48(5):731-744. doi: 10.1007/s10865-025-00574-x. Epub 2025 Jul 11.
PMID: 40643797DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Steel, PhD
University of Pittsburgh Physicians
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Surgery
Study Record Dates
First Submitted
January 5, 2016
First Posted
October 19, 2016
Study Start
June 1, 2016
Primary Completion
December 7, 2019
Study Completion
March 1, 2021
Last Updated
December 13, 2024
Record last verified: 2024-12