Improving Outcomes for Hemodialysis Patients

March 5, 2022 updated by: Shayan Shirazian, Columbia University

Improving Outcomes for Hemodialysis Patients by Addressing Poor Health Related Quality of Life With Cognitive Behavioral Strategies

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Hemodialysis (HD) patients have worse health related quality of life (HrQOL) than patients with any other chronic illness. In this population, poor quality of life and depressive symptoms (a major component of HrQOL) are associated with medication non-compliance, dietary indiscretion, interdialytic weight gain, and missed dialysis. These associations likely explain the link between low HrQOL scores and adverse medical outcomes. Even small decrements in HrQOL score are associated with an increased risk of hospitalizations and mortality. Moreover, depressive symptoms occur in one-third of HD patients and are themselves associated with increased hospitalizations and with a 1.5 times higher mortality risk.

To address poor HrQOL in HD patients, the Centers for Medicare Services (CMS) mandated its screening on a regular basis in all HD patients. However, CMS has not mandated how to present HrQOL results to key HD providers, or how to treat those with poor HrQOL. Nor are there widely applied methods of doing so. Although prior interventions in HD patients have improved quality of life and self-management, these interventions were limited by poor patient and physician adoption, a lack of reproducible methods, selective inclusion and exclusion criteria and a lack of translatability. To date there are no widely adopted interventions to improve quality of life in this population. Thus, it is not surprising that, HrQOL scores remain unchanged in 8 years since the CMS mandate. In sum, HrQOL survey results have not been applied in a manner that makes a difference for patients.

Cognitive behavioral therapy (CBT) is a structured psychotherapy intervention designed to address and treat dysfunctional cognitions, negative emotions and maladaptive behaviors. In patients with chronic illness, CBT has been adapted to successfully improve adherence to self-management behaviors. In patients with ESRD, several studies have used cognitive behavioral strategies to improve self-management, quality of life, and depressive symptoms. These studies however were limited by high drop-out rates and a lack of translatability. To date, cognitive behavioral (CB) strategies are not routinely used in the care of ESRD patients.

The investigators have developed a simple, translatable 3-step intervention to improve poor HrQOL in hemodialysis patients. The first step is a one-page dashboard that presents actionable HrQOL data to key stakeholders (social workers, nutritionists, primary nurses, nurse-practioners, physicians, patients and family members) during monthly case conference. The second step is a treatment approach that combines self-management education with CB strategies through 8-12 simple sessions delivered chair-side over 12 weeks. These sessions are designed to be delivered by unit social workers and are highly translatable to other US hemodialysis units. The final step is monthly re-evaluation at clinical case conference where patient progress will be assessed and the dashboard and behavioral-education sessions refined. Each step of the intervention was designed to be highly translatable to current hemodialysis care. The dashboard utilizes data that is currently checked, the treatment sessions are delivered by social workers that are already employed at hemodialysis centers and re-evaluation occurs during monthly case conference sessions that are already being held.

The investigators hypothesize that implementing their multi-faceted intervention will improve HrQOL, depressive symptoms and self-management, and will be immediately translatable to other US hemodialysis units. Therefore, the investigators propose to conduct a 16-week randomized controlled trial in 40 subjects on hemodialysis with poor HrQOL to test the impact of the intervention on these outcomes. The primary outcome, Kidney Disease Quality of Life Short Form 36 (KDQOL-36™) survey scores, will be measured at 0, 8, and 16 weeks. Through end-of-study focus groups, the investigators will refine the intervention and help translate our intervention into practice. Additionally, the investigators will develop a translatable toolbox that will give step-by-step instructions on how to implement our intervention at other US hemodialysis units. Finally, the investigators will explore the effect of our intervention on hospitalizations.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • DaVita Columbia University Dialysis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
0 weeks, 8 weeks, 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Satellite Healthcare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shayan Shirazian, MD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 28, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 28, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAAR6257

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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