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Improving Outcomes for Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03395366
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : August 5, 2019
Satellite Healthcare
Information provided by (Responsible Party):
Shayan Shirazian, Columbia University

Brief Summary:
End stage renal disease (ESRD) affects approximately 700,000 Americans of which approximately 400,000 are on life-saving hemodialysis therapy. Hemodialysis can take a physical and emotional toll on patients, and most patients on hemodialysis describe poor quality of life. Patients on hemodialysis have worse health related quality of life (HrQOL) than patients with any other chronic illness including cancer and congestive heart failure. This poor quality of life can affect how well these patients manage their own health or their self-care, and can ultimately lead to poor health outcomes. Despite this, there are no commonly used programs to improve quality of life or self-care for patients on hemodialysis. The investigators have developed a simple 3-step program to improve quality of life and self-care for patients on hemodialysis. The first step involves presenting quality of life scores to the dialysis health care team so that a program can be designed. The second step involves 8-12 education sessions combined with behavioral training designed to improve quality of life and self-care. The final step is monthly re-evaluation of progress. In this study, the investigators will test this 3-step program, compared to dialysis education alone, to see if it improves quality of life and self-care. By improving quality of life and self-care the investigators believe patient outcomes including hospitalizations will improve.

Condition or disease Intervention/treatment Phase
Quality of Life End Stage Renal Disease Other: Multifaceted Educational / Cognitive Behavioral Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study will be designed as a 16-week randomized controlled trial in which 40 subjects on hemodialysis with below average HrQOL will be assigned to one of two educational interventions.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Improving Outcomes for Hemodialysis Patients by Addressing Poor Health Related Quality of Life With Cognitive Behavioral Strategies
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Group 1
Multifaceted Educational / Cognitive Behavioral Intervention
Other: Multifaceted Educational / Cognitive Behavioral Intervention
The intervention includes 8 to 12 one-on-one sessions over a 12-week period, run by a licensed social worker (LSW) with experience delivering therapy. Curriculum will introduce education relevant for self-management and consists of prepared slides, handouts & worksheets. The education was designed based on slides developed and published online by the national kidney foundation and the national kidney disease education program. The curriculum was designed to be understandable by all potential subjects, including those with low literacy levels. Sessions will incorporate behavior-based activities designed to deliver education about and improve upon medication adherence, diet, exercise, and coping. These activities, based around CB strategies such as cognitive restructuring and behavior shaping, will include review of self-management logs, goal setting, creation of treatment plan, problem-solving techniques, reinforcing techniques, and coping with ESRD.

No Intervention: Group 2
Standard of Care + Dialysis Education without the Cognitive Behavioral component

Primary Outcome Measures :
  1. Change in score on Kidney Disease Quality of Life Short Form 36 (KDQOL-36™) [ Time Frame: 0 weeks, 8 weeks, 16 weeks ]
    The investigators will summarize the average changes from pre to post for each treatment arm via means (±SD) and 95% confidence intervals and estimate the effect of our intervention by estimating a linear model for each post-treatment score, adjusting for pre-treatment score and treatment arm (i.e. an ANCOVA model).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients on hemodialysis for at least 3 months
  • Most recent 36-question Kidney Disease Quality of Life (KDQOL-36), Physical Component Summary (PCS), or Mental Component Summary (MCS) score below 50
  • KDQOL-36 burden of disease score 80
  • Expected survival 6 months
  • English-speaking

Exclusion Criteria:

  • Bipolar or Psychotic disorder
  • Moderate or severe cognitive impairment as determined by the hemodialysis staff or documented in the electronic medical record (EMR)
  • Severe vision or hearing impairment
  • Drug or alcohol dependence
  • Active suicidal ideation or a history of suicide attempt (determined based on screening patient health questionnaire-9 and EMR)
  • Current participation in a behavioral or education treatment program

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 identifier (NCT number): NCT03395366

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Contact: Shayan Shirazian, MD 212-305-3273
Contact: Maya Rao, MD 212-305-3273

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United States, New York
DaVita Columbia University Dialysis Recruiting
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Satellite Healthcare
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Principal Investigator: Shayan Shirazian, MD Columbia University
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Responsible Party: Shayan Shirazian, Assistant Professor of Medicine, Columbia University Identifier: NCT03395366    
Other Study ID Numbers: AAAR6257
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Shayan Shirazian, Columbia University:
End Stage Renal Disease
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency