Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136253
Status:
COMPLETED
Last Update Posted:
2005-12-13
First Post:
2005-08-25
Brief Title:
Overcoming Nutritional Barriers in Hemodialysis Patients
Sponsor:
Case Western Reserve University
Organization:
Case Western Reserve University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2004-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None