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Assessing Novel Methods of Improving Patient Education of Nutrition

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ClinicalTrials.gov Identifier: NCT00394576
Recruitment Status : Completed
First Posted : November 1, 2006
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Behavioral: Internet-based nutrition module along with usual care Behavioral: usual care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assessing Novel Methods of Improving Patient Education of Nutrition: eHealth, Health Literacy and Chronic Kidney Disease
Study Start Date : November 2006
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: usual care plus Internet-based nutrition module
usual care plus Internet-based nutrition module
Behavioral: Internet-based nutrition module along with usual care
usual care plus Internet-based nutrition module

Active Comparator: usual care
usual care
Behavioral: usual care
usual care




Primary Outcome Measures :
  1. Gain in phosphorus knowledge as assessed by the chronic kidney disease Knowledge Assessment Tool (CKDKAT) of nutrition. [ Time Frame: 4 to 8 weeks post intial questionnaire/survey ]
    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.

  2. Compliance with dietary phosphorous will be measured by serum phosphorous level. [ Time Frame: 4 to 8 weeks after initial questionnaire/survey appointment ]
    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.

  3. Compliance with dietary phosphorous will be measured by serum calcium level [ Time Frame: 4 to 8 weeks after initial questionaire/survey appointment ]
    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. Compliance with dietary phosphorous will be measured by para thyroid hormone (PTH) level [ Time Frame: 4 to 8 weeks after initial questionnaire/survey appointment ]
    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.

  5. Compliance with dietary phosphorous will be measured by serum calcium phosphorus product. [ Time Frame: 4 to 8 weeks after initial questionnaire/survey appointment ]
    Measurement of compliance with dietary phosphorous will be measured by serum calcium phosphorus product.

  6. Compliance with dietary phosphorus intake will be measured by using 24 hour recall diary. [ Time Frame: 4 to 8 weeks after initial questionnaire/survey appointment ]
    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)


Secondary Outcome Measures :
  1. Correlations between dietary phosphorus intake, serum phosphorous levels and circulating endothelial cells (CECs) in CKD [ Time Frame: 2 years ]
    After all groups have completed their visits, correlations between dietary phosphorus intake, serum phosphorous levels and CECs will be made.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00394576


Locations
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United States, Wisconsin
UW Health Kidney Clinic and Wisconsin Dialysis
Madison, Wisconsin, United States, 53713
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Jonathan B Jaffery, MD School of Medicine and Public Health, University of Wisconsin

Additional Information:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00394576     History of Changes
Obsolete Identifiers: NCT00693277
Other Study ID Numbers: H-2006-0186-1
144-NR73 ( Other Grant/Funding Number: UW Clinical Research Scholars Program )
First Posted: November 1, 2006    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Keywords provided by University of Wisconsin, Madison:
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
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency