Assessing Novel Methods of Improving Patient Education of Nutrition
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|ClinicalTrials.gov Identifier: NCT00394576|
Recruitment Status : Unknown
Verified February 2009 by University of Wisconsin, Madison.
Recruitment status was: Recruiting
First Posted : November 1, 2006
Last Update Posted : February 16, 2009
- Research question Can a web-based nutritional educational intervention improve phosphorus knowledge and control of phosphorus intake?
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:
- Short form of the test of functional health literacy in adults: categorizes individuals as having adequate, marginal or inadequate health literacy.
- Chronic Kidney Disease (CKD) Knowledge Assessment Tool: addresses nutritional knowledge of CKD.
- SF-12 Health Survey version 2: a 12-item measure of health related quality of life.
- Kidney Disease Self-Management Survey: a 58-item Likert scale based on theories important for self-management in chronic disease.
- 3-Day Dietary Diaries
- 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
- Major risks to subjects There is the potential for some mild discomfort from the necessary blood draws, which occur twice per subjects.
- Potential benefits to subjects Subjects randomized to the web-based module may receive an educational benefit from it.
- 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 or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease||Behavioral: Internet-based nutrition module Behavioral: usual care||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessing Novel Methods of Improving Patient Education of Nutrition: eHealth, Health Literacy and Chronic Kidney Disease|
|Study Start Date :||November 2006|
|Estimated Primary Completion Date :||June 2009|
|Estimated Study Completion Date :||June 2009|
usual care plus Internet-based nutrition module
Behavioral: Internet-based nutrition module
usual care plus Internet-based nutrition module
Active Comparator: 2
Behavioral: usual care
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
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
|Contact: Jonathan B Jaffery, MDfirstname.lastname@example.org|
|Contact: Lynn M Jacobson, BSemail@example.com|
|United States, Wisconsin|
|UW Health Kidney Clinic and Wisconsin Dialysis||Recruiting|
|Madison, Wisconsin, United States, 53713|
|Principal Investigator: Jonathan B Jaffery, MD|
|Principal Investigator:||Jonathan B Jaffery, MD||University of Wisconsin-Madison School of Medicine and Public Health, Department of Medicine, Nephrology Section|