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Assessing Novel Methods of Improving Patient Education of Nutrition

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Wisconsin, Madison.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00394576
First received: October 30, 2006
Last updated: February 13, 2009
Last verified: February 2009
History of Changes
  Purpose
  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.

Condition Intervention
Chronic Kidney Disease
 Behavioral: Internet-based nutrition module
Behavioral: usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: Assessing Novel Methods of Improving Patient Education of Nutrition: eHealth, Health Literacy and Chronic Kidney Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • After one month gains in phosphorus knowledge will be assessed by the CKDKAT. [ Time Frame: 4 to 8 weeks post intial questionnaire/survey and placement in one of two groups ] [ Designated as safety issue: No ]
  • After one month compliance with dietary phosphorus intake will be measured by mineral metabolism laboratory values (serum phosphorus, calcium, PTH, calcium phosphorus product). [ Time Frame: 4 to 8 weeks after initial questionnaire/survey appointment ] [ Designated as safety issue: No ]
  • After one month compliance with dietary phosphorus intake will be measured by the 24 hour recall diary. [ Time Frame: 4 to 8 weeks after initial questionaire/survey appointment ] [ Designated as safety issue: No ]
  • After all groups have completed their visits, statistical comparisons will be made to determine whether eHealth information was able to improve patient knowledge of and compliance with recommended dietary phosphorous intake. [ Time Frame: two years for all subjects to be enrolled and data to be analyzed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • After all groups have completed their visits, correlations between dietary phosporus intake, serum phosphorous levels and CECs will be made. [ Time Frame: two years for all subjects to be enrolled, data to be analyzed ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: November 2006
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
usual care plus Internet-based nutrition module
 Behavioral: Internet-based nutrition module
usual care plus Internet-based nutrition module
Active Comparator: 2
usual care
 Behavioral: usual care
usual care

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00394576

Contacts
Contact: Jonathan B Jaffery, MD 608-270-5673 jbj@medicine.wisc.edu
Contact: Lynn M Jacobson, BS 608-265-5489 lmj@medicine.wisc.edu

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

Additional Information:
Kidney School(KS) is an online, personalized, interactive self-management learning center created by the Madison, WI based Medical Education Institute (MEI)  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Jonathan B. Jaffery, MD, University of Wisconsin
ClinicalTrials.gov Identifier: NCT00394576     History of Changes
Other Study ID Numbers: H-2006-0186-1, 5 K12 RRO17614A
Study First Received: October 30, 2006
Last Updated: February 13, 2009
Health Authority: United States: Institutional Review Board

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
Kidney Disease Self-Management Survey
Three Day Dietary Diary

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on June 18, 2013