ClinicalTrials.gg
CompletedNCT02938351Updated Dec 13, 2024

Collaborative Care Intervention for Chronic Kidney Disease

An interventional study of Collaborative care in Kidney Transplant, Depression and Pain, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 21 Years to 95 Years. Per ClinicalTrials.gov, last updated 2024-12-13.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
21 Years to 95 Years
Sex
All
01

Study 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.

Read the detailed description

Symptom management is critical to maintain quality of life in those with life limiting conditions. Stepped collaborative care interventions have been widely employed in the primary care setting for the treatment of depression and more recently have been utilized to treat other symptoms (e.g., pain) in a variety of settings. A recent meta-analyses concluded that collaborative care interventions were superior to usual care and are more cost-effective than face to face and pharmacological treatment for depression. Collaborative care interventions have begun to be extended to other settings but have not been tested in patients who are being treated with dialysis. The aims of the present study were 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.

02

Conditions studied

  • Kidney Transplant
  • Depression
  • Pain

Keywords

  • Collaborative care intervention
  • kidney transplant
03

In context

Depression

8,240 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 10 is below the median of 84 across 6,869 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,414 studies on the registry; 168 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Age 18 or older Currently receiving dialysis at UPMC dialysis facility for chronic kidney disease Fluent in English

Exclusion criteria

Exclusion Criteria:

Under the age of 18 years or over 90 years Not fluent in English

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    collaborative care

    To test the efficacy of a collaborative care intervention with patients treated with dialysis to reduce depression, pain, fatigue, and improve quality of life

    Behavioral: Collaborative care

Interventions

  • BehavioralCollaborative care

    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.

06

What researchers measure

Primary outcomes

  1. Depression Level

    score on CES-D questionnaire

    Time frame: change from baseline at 3 month and 6 month

  2. Perceived Stress level

    score on PSS questionnaire

    Time frame: change from baseline at 3 month and 6 month

  3. degree of Pain

    score on the BPI questionnaire

    Time frame: change from baseline at 3 month and 6 month

Secondary outcomes

  1. Dyadic functioning

    score on the Dyadic functioning questionnaire

    Time frame: change from baseline at 3 month and 6 month

  2. level of physical activity (mild, moderate or high)

    calculated score on the International Physical Activity quationnaire

    Time frame: change from baseline at 3 month and 6 month

  3. sleep quality

    score on the PSQI questionnaire

    Time frame: change from baseline at 3 month and 6 month

  4. quality of life

    score on the KDQOL questionnaire

    Time frame: change from baseline at 3 month and 6 month

07

Study locations

1 site
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania 15213, United States
08

References and documents

Publications

  • 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. PubMed 40643797 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02938351
Responsible party
Jennifer Steel (Associate Professor of Surgery, University of Pittsburgh) — Principal investigator
First posted
Oct 19, 2016
Start date
Jun 2016
Primary completion
Dec 7, 2019
Completion
Mar 1, 2021
Last update
Dec 13, 2024

Study contacts

Jennifer Steel, PhD
principal investigator · University of Pittsburgh Physicians

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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