Overcoming Nutritional Barriers in Hemodialysis Patients

This study has been completed.
Sponsor:
Information provided by:
Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT00136253
First received: August 25, 2005
Last updated: December 12, 2005
Last verified: October 2004
  Purpose

American hemodialysis patients are frequently malnourished. This contributes to dialysis patient mortality rates that are the highest in the industrialized world at 22% per year. Poor nutritional status probably also contributes to high health care costs (an average of two hospitalizations annually per patient and total Medicare expenditures of $11 billion per year) and diminished quality of life. The researchers' prior work identified several potentially modifiable nutritional barriers (e.g. poor appetite, inadequate dialysis dose, poor nutritional knowledge, low fluid intake, and needing help shopping and cooking) and pilot tested a promising approach to overcome these barriers.

This proposed community-based randomized controlled trial extends the researchers' prior work by targeting specific nutritional barriers with a tailored feedback and education intervention. Approximately 40 dialysis facilities in northeast Ohio will be randomly assigned to intervention and control groups, with approximately 100 malnourished patients enrolled from 20 intervention facilities and 100 from 20 control facilities. Baseline evaluation will include measures of nutritional status, specific barriers, inpatient expenditures, and quality of life. On a monthly basis for 12 months, intervention patients and their dietitians will receive tailored feedback and education on overcoming patient-specific barriers. They will then meet monthly to jointly formulate a care plan addressing these barriers. Control patients will continue to get usual care. Major analyses will compare changes in nutritional parameters in intervention vs. control patients with adjustment for nesting of patients within facilities.

The proposed project will test a novel intervention that targets patients and providers as they together make nutrition-related decisions. Overcoming specific barriers may lead not only to improved nutritional status but also to better patient survival, decreased health care costs, and increased quality of life.


Condition Intervention
End Stage Renal Disease
Behavioral: Help dietitians and patients address specific nutritional barriers

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • Change in albumin
  • Change in albumin of 0.20 or greater and survival

Secondary Outcome Measures:
  • Change in subjective global assessment, weight, dietary intake, specific nutritional barriers

Study Start Date: February 2002
Estimated Study Completion Date: October 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Most recent albumin and mean albumin over last 3 months <3.7 g/dL by bromcresol green method (or <3.4 g/dL by bromcresol purple method)
  • Age greater than or equal to 18 years
  • On chronic hemodialysis at least 9 months

Exclusion Criteria:

  • Mentally incompetent
  • Cirrhosis
  • AIDS
  • Cancer
  • Terminal illness
  • Malabsorption
  • Receiving total parenteral nutrition
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00136253

Sponsors and Collaborators
Case Western Reserve University
Investigators
Principal Investigator: Ashwini Sehgal, MD MetroHealth Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00136253     History of Changes
Other Study ID Numbers: DK51472
Study First Received: August 25, 2005
Last Updated: December 12, 2005
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on September 30, 2014