Collaborative Care Intervention for Chronic Kidney Disease

Overview

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.

Full Title of Study: “Collaborative Care Intervention for Kidney Transplant Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2019

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Depression Level
    • Time Frame: change from baseline at 3 month and 6 month
    • score on CES-D questionnaire
  • Perceived Stress level
    • Time Frame: change from baseline at 3 month and 6 month
    • score on PSS questionnaire
  • degree of Pain
    • Time Frame: change from baseline at 3 month and 6 month
    • score on the BPI questionnaire

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 95 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Pittsburgh
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jennifer Steel, Associate Professor of Surgery – University of Pittsburgh
  • Overall Official(s)
    • Jennifer Steel, PhD, Principal Investigator, University of Pittsburgh Physicians
  • Overall Contact(s)
    • Jennifer Steel, PhD, 412-692-2041, steeljl@upmc.edu

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