Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00394576
Status:
COMPLETED
Last Update Posted:
2019-05-06
First Post:
2006-10-30
Brief Title:
Assessing Novel Methods of Improving Patient Education of Nutrition
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Assessing Novel Methods of Improving Patient Education of Nutrition eHealth Health Literacy and Chronic Kidney Disease
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 SchoolKS 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 diseaseCKD 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 httpwwwkidneyschoolorg 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 httpwwwkidneyschoolorg 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 Doctorpatient 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
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 httpwwwkidneyschoolorg 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 httpwwwkidneyschoolorg 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 Doctorpatient 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 144-NR73 | OTHER_GRANT | UW Clinical Research Scholars Program | None |