Assessing Novel Methods of Improving Patient Education of Nutrition

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00693277
First received: June 3, 2008
Last updated: February 13, 2009
Last verified: February 2009

June 3, 2008
February 13, 2009
September 2006
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Complete list of historical versions of study NCT00693277 on ClinicalTrials.gov Archive Site
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Assessing Novel Methods of Improving Patient Education of Nutrition
Assessing Novel Methods of Improving Patient Education of Nutrition: eHealth, Health Literacy and Chronic Kidney Disease
  1. Research question Can a web-based nutritional educational intervention improve phosphorus knowledge and control of phosphorus intake?
  2. Experimental design

    Following enrollment and informed consent, subjects will be randomized to one of two arms (group1: usual care; group 2: usual care plus Internet-based nutrition module). All subjects will undergo baseline data collection, consisting of:

    1. Short form of the test of functional health literacy in adults: categorizes individuals as having adequate, marginal or inadequate health literacy.
    2. Chronic Kidney Disease (CKD) Knowledge Assessment Tool: addresses nutritional knowledge of CKD.
    3. SF-12 Health Survey version 2: a 12-item measure of health related quality of life.
    4. Kidney Disease Self-Management Survey: a 58-item Likert scale based on theories important for self-management in chronic disease.
    5. 3-Day Dietary Diaries
    6. Lab work:

    i. Serum phosphorus, calcium and parathyroid hormone levels. ii. Circulating endothelial cells, a novel marker for vascular damage.

    Following baseline data collection, group 1 will continue with their scheduled clinic visit, while group 2 will spend approximately 30 minutes completing a web-based nutrition module. After completion of the module, patients will proceed with their scheduled clinic visit.

    All subjects will then be asked to return in 30-60 days to repeat some of the survey information and blood work

  3. Major risks to subjects There is the potential for some mild discomfort from the necessary blood draws, which occur twice per subjects.
  4. Potential benefits to subjects Subjects randomized to the web-based module may receive an educational benefit from it.
  5. Consent procedures Only individuals who can provide their own consent can participate. Upon agreeing to enroll, a study coordinator or investigator will provide the subject with a copy of the consent form, and will remain available to answer any questions.

Specific Aim 1: To examine the effect of a novel, web-based method of educating CKD patients on patient knowledge and dietary intake of phosphorus. We will compare 2 methods for educating CKD patients about dietary phosphorus intake:

  1. Usual care, consisting of individualized care/counseling by a nephrologist.
  2. Usual care, plus review of the Kidney School (KS) Nutrition Module (see below). To compare gains in phosphorus knowledge after 1 month. To compare compliance with dietary phosphorus intake, as measured by mineral metabolism laboratory values (serum phosphorus, calcium, PTH, calcium-phosphorus product) and 3-day dietary diaries.

Specific Aim 2: To determine if the S-TOFHLA predicts CKD patients' knowledge and compliance with recommended dietary phosphorus intake:

  1. To measure health literacy in patients undergoing maintenance hemodialysis, using the S-TOFHLA.
  2. To assess correlations between health literacy and knowledge of phosphorus.
  3. To assess correlations between health literacy and compliance with CKD dietary phosphorus guidelines, as measured by mineral metabolism laboratory values (serum phosphorus, calcium, PTH, calcium-phosphorus product), and dietary phosphate intake, as measured by 3-day dietary diaries.
  4. To assess correlations between health literacy and compliance with CKD dietary phosphorus guidelines, following usual care versus an eHealth nutrition intervention.

Specific Aim 3: To determine if higher dietary phosphorus intake correlates with higher levels of CECs.

  1. To measure CEC levels in patients with CKD.
  2. To assess correlations between dietary phosphorus intake, serum phosphorus levels, and CECs in patients with CKD.
Interventional
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Healthy
Behavioral: web-based nutritional educational intervention
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
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September 2008
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Inclusion Criteria:

  • none - study withdrawn

Exclusion Criteria:

  • none - study withdrawn
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Contact information is only displayed when the study is recruiting subjects
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NCT00693277
H-2006-0186, 5 K12 RR017614A
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University of Wisconsin, Madison
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Principal Investigator: Jonathan B Jaffery, MD University of Wisconsin, Madison
University of Wisconsin, Madison
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP