Assessing Novel Methods of Improving Patient Education of Nutrition

NCT00394576 | Completed

• 2 other identifiers: H-2006-0186-1144-NR73
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The relationship between elevated phosphorus levels and morbidity and mortality in patients with chronic kidney disease (CKD) is well recognized, and dietary phosphorus restriction is a mainstay of phosphate management. Current study is an effort to test the effect of a web-based nutritional educational intervention, Kidney School(KS), to improve phosphorous knowledge and control phosphorous intake in CKD patients.

Conditions

Chronic Kidney Disease

Keywords

Kidney School; Short Test of Functional Health Literacy; Chronic Kidney Disease Knowledge Assessment Tool of Nutrition; Short Form 12 version 2; Three Day Dietary Diary; Kidney Disease Self-Management Survey

Outcome Measures

Primary Outcomes (6)

• Gain in phosphorus knowledge as assessed by the chronic kidney disease Knowledge Assessment Tool (CKDKAT) of nutrition.

  The CKDKAT of nutrition is a revised version of the original CKDKAT, which addresses only nutritional knowledge specific to chronic kidney disease (CKD). 15 of 25 questions are phosphorus-specific, with the remaining 10 concerning sodium, potassium and protein intake.

  4 to 8 weeks post intial questionnaire/survey

• Compliance with dietary phosphorous will be measured by serum phosphorous level.

  Measurement of compliance with dietary phosphorous will be measured by serum phosphorous level. In CKD, Phosphorus excretion diminishes, leading to an increase in serum phosphorus levels.

  4 to 8 weeks after initial questionnaire/survey appointment

• Compliance with dietary phosphorous will be measured by serum calcium level

  Measurement of compliance with dietary phosphorous will be measured by serum calcium level. In CKD, calcium is not reabsorbed, leading to decreased serum calcium.

  4 to 8 weeks after initial questionaire/survey appointment

• Compliance with dietary phosphorous will be measured by para thyroid hormone (PTH) level

  Measurement of compliance with dietary phosphorous will be measured by para thyroid hormone (PTH) level. In CKD, Both decreased serum calcium levels and increased serum phosphorus levels stimulate excessive secretion of PTH.

  4 to 8 weeks after initial questionnaire/survey appointment

• Compliance with dietary phosphorous will be measured by serum calcium phosphorus product.

  Measurement of compliance with dietary phosphorous will be measured by serum calcium phosphorus product.

  4 to 8 weeks after initial questionnaire/survey appointment

• Compliance with dietary phosphorus intake will be measured by using 24 hour recall diary.

  For measuring compliance with dietary phosphorus intake, data will be collected by 24 hour recall diaries. Nutrient analysis data will be analyzed by Food Processor SQL Nutrition Software (ESHA Research, Salem, Oregon)

  4 to 8 weeks after initial questionnaire/survey appointment

Secondary Outcomes (1)

• Correlations between dietary phosphorus intake, serum phosphorous levels and circulating endothelial cells (CECs) in CKD

  2 years

Study Arms (2)

usual care plus Internet-based nutrition module

EXPERIMENTAL

usual care plus Internet-based nutrition module

Behavioral: Internet-based nutrition module along with usual care

usual care

ACTIVE COMPARATOR

usual care

Behavioral: usual care

Interventions

Internet-based nutrition module along with usual care BEHAVIORAL

usual care plus Internet-based nutrition module

usual care plus Internet-based nutrition module

usual care BEHAVIORAL

usual care

usual care

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18 and less than 90
• Chronic kidney disease stage 3, 4 or 5
• Adequate visual acuity with correction to allow discrimination of 14-point type
• Ability to read English
• Ability to provide informed consent

You may not qualify if:

• Anticipated need for renal replacement therapy within 60 days
• Prison population

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

UW Health Kidney Clinic and Wisconsin Dialysis

Madison, Wisconsin, 53713, United States

Location

Related Publications (1)

• Campbell ZC, Dawson JK, Kirkendall SM, McCaffery KJ, Jansen J, Campbell KL, Lee VW, Webster AC. Interventions for improving health literacy in people with chronic kidney disease. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD012026. doi: 10.1002/14651858.CD012026.pub2.

  PMID: 36472416 DERIVED

Related Links

• Kidney School(KS) is an online, personalized, interactive self-management learning center created by the Madison, WI based Medical Education Institute (MEI)

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan B Jaffery, MD

  School of Medicine and Public Health, University of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2006
• First Posted: November 1, 2006
• Study Start: November 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: May 6, 2019

Record last verified: 2019-05

Locations

US (1)