Assessing Novel Methods of Improving Patient Education of Nutrition
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      The relationship between elevated phosphorus levels and morbidity and mortality in patients
      with chronic kidney disease (CKD) is well recognized, and dietary phosphorus restriction is a
      mainstay of phosphate management. Current study is an effort to test the effect of a
      web-based nutritional educational intervention, Kidney School(KS), to improve phosphorous
      knowledge and control phosphorous intake in CKD patients.
    

Detailed description: 
      The relationship between elevated phosphorous level in the severity of Chronic kidney
      disease(CKD) is well documented. However, appropriate control of phosphate intake remains
      sub-par, due in part to the difficulties that patients have understanding phosphate content
      in foods.

      Randomized trials have shown that intensive, individualized dietary counseling can improve
      patient knowledge about phosphorus and help control hyperphosphatemia; however, maintaining
      this level of counseling is time-consuming, costly, and impractical. Given the recognized
      nephrology workforce shortage, there is a crucial need for systems to fill this gap with
      novel technologies to educate patients, and it is vital that a better understanding of the
      effects of novel nutritional intervention counseling methods on patient knowledge,
      nutritional intake and nutritional status be evaluated in CKD patients.

      Furthermore, to effectively engage in the patient side of the education process, those who
      receive it, the patients, must be able to comprehend information and draw on it for
      decision-making. Novel educational interventions may be better suited than traditional
      methods to circumvent literacy limitations. Therefore, it is vital to assess the relation of
      functional health literacy of this population in both traditional and emerging educational
      venues.

      Kidney School (KS, http://www.kidneyschool.org) is an online, personalized, interactive
      self-management learning center created by the Madison, WI based Medical Education Institute
      (MEI) and organized into fifteen 20-30 minute modules, each focused on a different topic
      related to kidney disease and its treatment, including nutrition. Content is based on 10
      years of research conducted by the Life Options Rehabilitation Program, with internal and
      external expert review. The nutrition module is tailored for patients with or without
      diabetes.

      The importance of phosphorus control for patients with CKD has traditionally been vital to
      prevent bone disease. More recently it is recognized that poor phosphorus control correlates
      with cardiovascular disease, of which patients with CKD carry an enormous burden. Similarly,
      there has recently been much attention to circulating endothelial cells (CECs) as a novel
      marker for cardiovascular risk in this population. While the ultimate test would be to
      determine if controlling phosphorus impacts on cardiovascular events, that is beyond the
      scope of this project. Therefore, we propose to measure levels of CECs as an intermediary
      step toward cardiovascular events, in correlation to phosphorus intake.

      Following enrollment and informed consent, subjects will be randomized to one of two arms
      [group1: usual care; group 2: usual care plus Kidney School (KS)].

      Kidney School (KS, http://www.kidneyschool.org) is an online, personalized, interactive
      self-management learning center created by the Madison, WI based Medical Education Institute
      (MEI) and organized into fifteen 20-30 minute modules, each focused on a different topic
      related to kidney disease and its treatment, including nutrition. Content is based on 10
      years of research conducted by the Life Options Rehabilitation Program, with internal and
      external expert review. The nutrition module is tailored for patients with or without
      diabetes.

      Proprietary Information. The mission of the non-profit MEI is to help people with chronic
      diseases learn to manage and improve their health, through research and education. The MEI
      believes charging a fee for educational materials can be a barrier between patients and the
      information they need to live successfully with a chronic disease. All MEI-developed patient
      education materials are therefore free. KS is entirely proprietary to the MEI, but will
      continue to be available free of charge via the Internet. KS is fully compliant with HIPAA
      standards.

      The SF-12 Health Survey version 2 is a 12-item measure of health related quality of life.
      Widely used in research in a variety of disease states, including CKD, it provides physical
      and mental component summary scores with a strong concordance with the lengthier SF-36. Given
      that we will be administering multiple cognitive and behavioral surveys to subjects, the
      shorter version will be used.

      Kidney Disease Self-Management Survey (KDSMS). Developed by MEI, the KDSMS is a 58-item
      Likert scale with 6 subscales, based on theories deemed important for self-management
      education in other chronic diseases, including the health belief model, self-efficacy,
      behavioral intent, and the transtheoretical model. These theories converge into a
      self-management education schema that emphasizes the importance of information, support,
      modeling, planning, practice and monitoring, and reflection in patient self-management
      education. The 6 subscales are: 1) Self-monitoring, 2) Adjusting to symptoms, 3) Lifestyle
      behaviors, 4) Medication-taking, 5) Information seeking, 6) Doctor/patient communication.

      24 hour recall diaries - After collecting the information from subjects, nutrient analysis
      will be performed using The Food Processor SQL Nutrition Software (ESHA Research, Salem,
      Oregon).

      The study instruments will all performed for research purposes. While some of them (the
      S-TOFHLA, 3-Day Dietary Diaries) have been used as part of patient care, this is not routine,
      and it is not done at our facilities.

      Lab work collected will consist of serum phosphorus, calcium and intact-parathyroid hormone
      levels. As these are routinely collected prior to or during a regular CKD clinic visit, the
      study coordinator will check to see if this data is already available, and will not duplicate
      this blood work if it is. In addition, all subjects will have blood drawn (30 ml) for
      assessment of circulating endothelial cells (CECs), 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 the KS nutrition module at a
      dedicated computer education station at the UW Kidney Clinic. The study coordinator will
      bring up the KS nutrition module (tailored for diabetes as a co-morbidity if appropriate).
      After completion of the KS nutrition module, patients will receive a personalize action plan,
      and then 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.
    

Intervention name(s): Internet-based nutrition module along with usual care; usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): usual care plus Internet-based nutrition module; usual care
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Kidney School; Short Test of Functional Health Literacy; Chronic Kidney Disease Knowledge Assessment Tool of Nutrition; Short Form 12 version 2; Three Day Dietary Diary; Kidney Disease Self-Management Survey