Assessing Novel Methods of Improving Patient Education of Nutrition
|ClinicalTrials.gov Identifier: NCT00693277|
Recruitment Status : Withdrawn
First Posted : June 9, 2008
Last Update Posted : October 8, 2015
- 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|
|Healthy||Behavioral: web-based nutritional educational intervention||Not Applicable|
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:
- Usual care, consisting of individualized care/counseling by a nephrologist.
- 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:
- To measure health literacy in patients undergoing maintenance hemodialysis, using the S-TOFHLA.
- To assess correlations between health literacy and knowledge of phosphorus.
- 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.
- 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.
- To measure CEC levels in patients with CKD.
- To assess correlations between dietary phosphorus intake, serum phosphorus levels, and CECs in patients with CKD.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Official Title:||Assessing Novel Methods of Improving Patient Education of Nutrition: eHealth, Health Literacy and Chronic Kidney Disease|
|Study Start Date :||September 2006|
|Estimated Study Completion Date :||September 2008|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00693277
|Principal Investigator:||Jonathan B Jaffery, MD||University of Wisconsin, Madison|