Assessing Novel Methods of Improving Patient Education of Nutrition - Full Text View

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00394576

Purpose

Research question Can a web-based nutritional educational intervention improve phosphorus knowledge and control of phosphorus intake?
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
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	Intervention
Chronic Kidney Disease	Behavioral: Internet-based nutrition module Behavioral: usual care

MedlinePlus related topics: Calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title:	Assessing Novel Methods of Improving Patient Education of Nutrition: eHealth, Health Literacy and Chronic Kidney Disease

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
1: Experimental usual care plus Internet-based nutrition module	Behavioral: Internet-based nutrition module usual care plus Internet-based nutrition module
2: Active Comparator 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

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

This link exits the ClinicalTrials.gov site

Responsible Party:	University of Wisconsin ( Jonathan B. Jaffery, MD )
Study ID Numbers:	H-2006-0186-1, 5 K12 RRO17614A
Study First Received:	October 30, 2006
Last Updated:	January 11, 2008
ClinicalTrials.gov Identifier:	NCT00394576
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

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on January 16, 2009