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Collaborative Care Intervention for Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT02938351
Recruitment Status : Recruiting
First Posted : October 19, 2016
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Jennifer Steel, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Kidney Transplant Depression Pain Behavioral: Collaborative care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Patient and caregiver will receive an IPAD with Vidyo software to complete the treatment sessions
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Collaborative Care Intervention for Kidney Transplant Patients
Actual Study Start Date : June 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Depression Level [ Time Frame: change from baseline at 3 month and 6 month ]
    score on CES-D questionnaire

  2. Perceived Stress level [ Time Frame: change from baseline at 3 month and 6 month ]
    score on PSS questionnaire

  3. degree of Pain [ Time Frame: change from baseline at 3 month and 6 month ]
    score on the BPI questionnaire


Secondary Outcome Measures :
  1. Dyadic functioning [ Time Frame: change from baseline at 3 month and 6 month ]
    score on the Dyadic functioning questionnaire

  2. 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

  3. sleep quality [ Time Frame: change from baseline at 3 month and 6 month ]
    score on the PSQI questionnaire

  4. quality of life [ Time Frame: change from baseline at 3 month and 6 month ]
    score on the KDQOL questionnaire



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Ages Eligible for Study:   21 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938351


Contacts
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Contact: Jennifer Steel, PhD 412-692-2041 steeljl@upmc.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Jennifer L Steel, Ph.D.         
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Jennifer Steel, PhD University of Pittsburgh Physicians

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Responsible Party: Jennifer Steel, Associate Professor of Surgery, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02938351     History of Changes
Other Study ID Numbers: PRO15110210
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jennifer Steel, University of Pittsburgh:
Collaborative care intervention
kidney transplant