Improving Outcomes for Hemodialysis Patients

NCT03395366 | Completed

• 1 other identifier: AAAR6257
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; End Stage Renal Disease

Keywords

Hemodialysis; End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Change in score on Kidney Disease Quality of Life Short Form 36 (KDQOL-36™)

  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

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Multifaceted Educational / Cognitive Behavioral Intervention

Other: Multifaceted Educational / Cognitive Behavioral Intervention

Group 2

NO INTERVENTION

Standard of Care + Dialysis Education without the Cognitive Behavioral component

Interventions

Multifaceted Educational / Cognitive Behavioral Intervention OTHER

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.

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Satellite Healthcare: collaborator

Study Sites (1)

DaVita Columbia University Dialysis

New York, New York, 10032, United States

Location

Related Publications (1)

• Shirazian S, Smaldone AM, Jacobson AM, Fazzari MJ, Weinger K. Improving quality of life and self-care for patients on hemodialysis using cognitive behavioral strategies: A randomized controlled pilot trial. PLoS One. 2023 May 4;18(5):e0285156. doi: 10.1371/journal.pone.0285156. eCollection 2023.

  PMID: 37141225 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shayan Shirazian, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: January 10, 2018
• Study Start: May 1, 2018
• Primary Completion: April 28, 2020
• Study Completion: April 28, 2020
• Last Updated: March 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)