Overcoming Nutritional Barriers in Hemodialysis Patients

End Stage Renal Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00136253
• Other study ID #: DK51472
• Status: Completed
• Phase: N/A
• First received: August 25, 2005
• Last updated: December 12, 2005
• Start date: February 2002
• Est. completion date: October 2004

Study information

• Verified date: October 2004
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Behavioral:
• Help dietitians and patients address specific nutritional barriers

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Case Western Reserve University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in albumin
Primary	Change in albumin of 0.20 or greater and survival
Secondary	Change in subjective global assessment, weight, dietary intake, specific nutritional barriers