NCT02938351

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

3.5 years

First QC Date

January 5, 2016

Last Update Submit

December 11, 2024

Conditions

Keywords

Collaborative care interventionkidney transplant

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

EXPERIMENTAL

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

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.

collaborative care

Eligibility Criteria

Age21 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

DepressionPain

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jennifer Steel, PhD

    University of Pittsburgh Physicians

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Patient and caregiver will receive an IPAD with Vidyo software to complete the treatment sessions
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

Locations