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Overcoming Nutritional Barriers in Hemodialysis Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00136253
Enrollment
Unknown
Registered
2005-08-29
Start date
2002-02-28
Completion date
2004-10-31
Last updated
2005-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease

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.

Interventions

BEHAVIORALHelp dietitians and patients address specific nutritional barriers

Sponsors

Case Western Reserve University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in albumin
Change in albumin of 0.20 or greater and survival

Secondary

MeasureTime frame
Change in subjective global assessment, weight, dietary intake, specific nutritional barriers

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026