Collaborative Care Intervention for Chronic Kidney Disease

Collaborative Care Intervention for Kidney Transplant Patients

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.

Study Overview

• Status: Completed
• Conditions: Depression; Pain; Kidney Transplant
• Intervention / Treatment: Behavioral: Collaborative care

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyadic functioning	score on the Dyadic functioning questionnaire	change from baseline at 3 month and 6 month
level of physical activity (mild, moderate or high)	calculated score on the International Physical Activity quationnaire	change from baseline at 3 month and 6 month
sleep quality	score on the PSQI questionnaire	change from baseline at 3 month and 6 month
quality of life	score on the KDQOL questionnaire	change from baseline at 3 month and 6 month

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Jennifer Steel, PhD, University of Pittsburgh Physicians

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): December 7, 2019
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: January 5, 2016
• First Submitted That Met QC Criteria: October 17, 2016
• First Posted (Estimate): October 19, 2016

Study Record Updates

• Last Update Posted (Actual): May 4, 2021
• Last Update Submitted That Met QC Criteria: May 3, 2021
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: kidney transplant; Collaborative care intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: PRO15110210

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No