An interventional study of Help dietitians and patients address specific nutritional barriers in End Stage Renal Disease, sponsored by Case Western Reserve University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-12-13.
Sponsored by Case Western Reserve University · Not applicable and Interventional
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.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 261 are open to participants now.
Browse Kidney Failure, Chronic studies →Case Western Reserve University is the lead sponsor of 158 studies on the registry; 29 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Exclusion Criteria:
Change in albumin
Change in albumin of 0.20 or greater and survival
Change in subjective global assessment, weight, dietary intake, specific nutritional barriers
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This study is completed, as verified in Oct 2004. You cannot join it, but the record below documents what was studied.
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Case Western Reserve University