Assessing Novel Methods of Improving Patient Education of Nutrition

• 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 ]

• After one month gains in phosphorus knowledge will be assessed by the CKDKAT.
• After one month compliance with dietary phosphorus intake will be measured by mineral metabolism laboratory values (serum phosphorus, calcium, PTH, calcium phosphorus product).
• After one month compliance with dietary phosphorus intake will be measured by the 24 hour recall diary.
• 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 phospherous intake.

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.

Study Description

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. Despite this, 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.

Finally, the importance of phosphorus control for patients with CKD has traditionally been 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.

Hypothesis 1: Novel nutritional educational interventions of dietary phosphorus can be useful for providing improvements on phosphorus knowledge and control of intake. Significance: Such methods can be self-sustaining, and therefore a practical solution to the problem of providing continuous and repeated educational interventions given limited provider time and resources.

Hypothesis 2: A higher level of health literacy in individuals with CKD is associated with greater knowledge of and compliance with recommended dietary phosphorus intake. Significance: A better understanding of obstacles to optimal nutritional intake will lead to improved methods for nutrition intervention counseling. Alternative measures to educate those with lower health literacy may require a shifting of resources for this subgroup of individuals.

Hypothesis 3: Higher dietary phosphorus intake in individuals with CKD correlates with higher levels of CECs.

Study Design

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:

1. Usual care, consisting of individualized care/counseling by a nephrologist.
2. 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:

1. To measure health literacy in patients undergoing maintenance hemodialysis, using the S-TOFHLA.
2. To assess correlations between health literacy and knowledge of phosphorus.
3. 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.
4. 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.

1. To measure CEC levels in patients with CKD.
2. To assess correlations between dietary phosphorus intake, serum phosphorus levels, and CECs in patients with CKD.

Following enrollment and informed consent, subjects will be randomized to one of two arms (group1: usual care; group 2: usual care plus KS module). All subjects will undergo baseline data collection, as shown in table 1. KS and Survey information is as follows:

Kidney School (KS). 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.

KS modules contain a pre/post-test, instructional content, patient quotes, graphics/animations, photos, pop-ups, a resource list containing books and relevant website links, and a certificate of completion. The content branches to provide tailored information to each user according to user responses. These responses also create a Personal Action Plan in each module that can be printed and used for content review and setting goals. A custom graphic interface with navigation buttons was designed for KS, and each module has customized Javascript programming, as the content branching patterns are unique.

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.

HIPAA. KS is fully compliant with HIPAA standards. S-TOFHLA. An abbreviated version of the test of functional health literacy in adults, the S-TOFHLA is widely used by health care providers to determine the adequacy of their patients' understanding of health care materials needed for their health care or education, as well as by researchers to assess health literacy as a variable in research. It categorizes individuals as having adequate, marginal or inadequate health literacy, can be administered in 12 minutes, and has been used in patients with a variety of chronic diseases.

CKD Knowledge Assessment Tool (CKDKAT) of Nutrition. The CKDKAT of nutrition is a revised version of our original CKDKAT, which addresses only nutritional knowledge specific to CKD. Fifteen of 25 questions are phosphorus-specific, with the remaining 10 concerning sodium, potassium and protein intake.

SF-12v2. 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.

Subject Population

All subjects (N = 100) will be recruited from the UW Health Kidney Clinic. We will recruit individuals in the later stages of kidney disease: Stages 3 and 4. Staging of CKD is determined by estimating the glomerular filtration rate (e-GFR). The e-GFR is automatically calculated with each outpatient serum creatinine ordered through the UW labs, and so this information is readily available. Stage 3 is defined as GFR of 30-59 milliliters/minute (~ ½ to ¼ of normal kidney function), and Stage 4 is defined as a GFR of 15-29 milliliters/minute (~ ¼ to ⅛ of normal kidney function). Stage 5 is kidney failure (GFR < 15 milliliters/minute).

All patients between the ages of 18 and 89 with CKD stage 3 or 4 who are seen in the UW Health Kidney Clinic will be invited to participate in the study by a member of the study personnel prior to beginning the class or while waiting for their clinic visit. Fliers briefly describing the study with contact information for those interested will be available at the receptionist area in the UW Kidney Clinic and in the computer-station education area. Demographic information collected will include age, gender, race, length of time with known CKD, education level, and home computer ownership.

Subjects will receive modest compensation for their time and effort ($10 after completion of first set of data collection, $25 after completion of follow up data collection). No project personnel will receive incentives for recruiting human subjects or for any other purpose directly related to the study. The greater amount offered for the second visit is due to the added inconvenience of returning for an additional visit.

Note, as prisoners are not seen in the UW Kidney Clinic, the study will not involve this population.

Statistical Justification of Sample Size

We propose a sample size of 50 subjects for each of the cohorts. Pairwise comparisons of mean knowledge scores of Cohort 2 with Cohort 1 (i.e., the original cohort taking the test prior to any educational intervention) will be conducted using two-sided t-tests to detect a p-value of < 0.05. Adjustments will be made for demographic factors known to be related to chronic disease knowledge, including age, race, gender and education. The effective sample size will provide 80% power to detect a difference in mean knowledge scores of 3 or more questions.

Correlation between higher levels of functional health literacy and increased knowledge of kidney disease will be determined using Spearman rank-order correlation.

Risks and Benefits to Participants

It is not anticipated that there are any significant or sustained risks to subjects of participation in the study. There is the potential for some mild discomfort from the necessary blood draws, which occur twice per subjects.

Personal benefits to subjects: Subjects randomized to the KS nutrition module may receive benefit from the personalized action plan, and may gain knowledge of nutritional needs for their chronic condition.

Scientific benefits from the study: A better understanding of obstacles to optimal nutritional intake will lead to improved methods for nutrition intervention counseling. Alternative measures to educate those with lower health literacy may require a shifting of resources for this subgroup of individuals.

Consent Procedures

As the study requires the ability to fill out multiple surveys and use the Internet, only individuals who can provide their own consent can participate. The consent process will be conducted by either the Study Coordinator (Lynn Jacobson) or the PI (Jonathan Jaffery). Upon agreeing to enroll in the study, the subject with a copy of the consent form (see attached). The individual obtaining consent will remain available to answer any and all questions.

Changes to the protocol were submitted and approved:

The changes are being made because additional funding has been awarded to look further at the same question in a slightly different patient population. The previously approved study enrolls individuals with chronic kidney disease (CKD) stages 3 and 4 (moderate to severe CKD). The proposed changes will include individuals with CKD 5 (end-stage kidney disease) undergoing maintenance hemodialysis (MD). Given the major differences in how these groups of patients receive care (clinic visits averaging every 3-6 months with occasional blood work and primarily oral medications arranged per provider discretion for those with CKD 3 and 4, versus dialysis unit treatments of 3-4 hours/3 times weekly, with monthly blood work and various oral and IV medications prescribed per protocols for those with CKD 5 on MD), it is important to assess the proposed questions in both distinct groups.

1. Will enroll an additional 80 subjects, all with CKD 5, undergoing MD
2. Subjects will be randomized (1:1) to receive standard of care versus the intervention with the tailored, web-based CKD nutrition module
3. Other interventions will be (for all 80 subjects) the same questionnaire instruments as previously described
4. The timetable/duration of the study will be different for the MD group versus the CKD 3/4 group (see below)
5. No separate blood draws will be required of the MD group, as all the relevant lab tests are measured as standard of care and recorded in the dialysis clinical database

Subjects with CKD 5 will have a decreased risk of adverse effects, due to the lack of any need for blood draws. Additionally, the time spent performing study questionnaires or engaging with the web-based module (via wireless-enabled laptop) will be during the 3-4 hour dialysis treatment, and so will not prolong their visit length. Subjects with CKD 3 and 4 will not be affected by the changes.

• Behavioral: Internet-based nutrition module
  usual care plus Internet-based nutrition module
• Behavioral: usual care
  usual care

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

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