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Collaborative Care Intervention for Chronic Kidney Disease

NCT ID: NCT02938351

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2021-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Kidney Transplant Depression Pain

Keywords

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Collaborative care intervention kidney transplant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patient and caregiver will receive an IPAD with Vidyo software to complete the treatment sessions
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Collaborative care

Intervention Type BEHAVIORAL

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.

Interventions

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Collaborative 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

21 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Steel

Associate Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Steel, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Physicians

Locations

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University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40643797 (View on PubMed)

Other Identifiers

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PRO15110210

Identifier Type: -

Identifier Source: org_study_id