Overcoming Nutritional Barriers in Hemodialysis Patients

NCT ID: NCT00136253

Last Updated: 2005-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28
• Study Completion Date: 2004-10-31

Brief 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.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Interventions

Help dietitians and patients address specific nutritional barriers

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Western Reserve University

OTHER

Sponsor Role: lead

Principal Investigators

Ashwini Sehgal, MD

Role: PRINCIPAL_INVESTIGATOR

MetroHealth Medical Center

Other Identifiers

DK51472

Identifier Type: -

Identifier Source: org_study_id