Targeting Social Determinants to Improve Chronic Kidney Disease Care
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
interactive educational intervention
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring health literacy, health numeracy
Eligibility Criteria
Inclusion Criteria:
- Receiving care in the Vanderbilt General Nephrology Clinic for at least 1 prior visit past 12 months;
- Serum creatinine available in the medical record in the last 12 months demonstrating Chronic Kidney Disease (eGFR<60mls/min);
- Age 18-80 years;
- English-speaking.
Exclusion Criteria:
- Pre-existing diagnosis of significant dementia or psychosis as determined by primary provider and documented in the medical record;
- Corrected visual Acuity >60/20 using a Rosenbaum Pocket Vision Screen;
- Patient receives dialysis or has a functional kidney transplant.
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
interactive educational intervention
control group
Arm Description
Physicians will use an interactive educational worksheet during the standard-of-care clinic visit.
Physicians will conduct the standard-of-care clinic visit as usual.
Outcomes
Primary Outcome Measures
self-care of Chronic Kidney Disease
Change from baseline in the following surveys/questionaires at 6 months
Morisky 8-Item Survey
Frequent Food Questionaire
Secondary Outcome Measures
patient understanding of kidney disease and their disease status
Change from baseline in the following surveys/questionaires at 6 months
Kidney Awareness & Knowledge Survey
Perceived Kidney Self-Management Scale
Kidney Disease Self-Management Behaviors
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01604577
Brief Title
Targeting Social Determinants to Improve Chronic Kidney Disease Care
Official Title
Targeting Social Determinants to Improve Chronic Kidney Disease Care
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary research goals of this application are to characterize social factors including health literacy and numeracy skills of CKD patients and examine associations with knowledge, self-efficacy, self-care behaviors, and clinical outcomes, and to examine the impact of an efficient interactive educational intervention to facilitate patient-provider communication. The investigators will accomplish these goals by executing a cluster-randomized controlled trial and performing detailed analysis of baseline measures. The specific aims of this study are:
Specific Aim 1: Determine the association of social factors with patient kidney knowledge, self-efficacy, participation in self-care behaviors, and clinical outcomes in moderate to advanced CKD.
Hypothesis: In patients with CKD, low health literacy and numeracy is common and associated with older age, non-white race, fewer years of education, lower socioeconomic (income) status, less kidney knowledge, lower self-efficacy of self-care, and less adherence with medication and diet self-care recommendations. Low literacy/numeracy is also associated with higher blood pressures, more proteinuria, and more severe dysfunction of renal clearance.
Specific Aim 2: Evaluate the impact of a tailored literacy-sensitive educational tool used cooperatively by physicians and patients to improve self-care and outcomes in CKD.
Hypothesis: Utilization of a concise literacy-sensitive physician-delivered educational tool will be feasible and associated with higher patient kidney knowledge, self-efficacy of self-care and greater adherence to medication and nutrition recommendations compared to usual care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
health literacy, health numeracy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
273 (Actual)
8. Arms, Groups, and Interventions
Arm Title
interactive educational intervention
Arm Type
Active Comparator
Arm Description
Physicians will use an interactive educational worksheet during the standard-of-care clinic visit.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Physicians will conduct the standard-of-care clinic visit as usual.
Intervention Type
Behavioral
Intervention Name(s)
interactive educational intervention
Intervention Description
Use of a concise, literacy-sensitive, physician-led, educational interaction with the patient.
Primary Outcome Measure Information:
Title
self-care of Chronic Kidney Disease
Description
Change from baseline in the following surveys/questionaires at 6 months
Morisky 8-Item Survey
Frequent Food Questionaire
Time Frame
baseline and 6 months
Secondary Outcome Measure Information:
Title
patient understanding of kidney disease and their disease status
Description
Change from baseline in the following surveys/questionaires at 6 months
Kidney Awareness & Knowledge Survey
Perceived Kidney Self-Management Scale
Kidney Disease Self-Management Behaviors
Time Frame
baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Receiving care in the Vanderbilt General Nephrology Clinic for at least 1 prior visit past 12 months;
Serum creatinine available in the medical record in the last 12 months demonstrating Chronic Kidney Disease (eGFR<60mls/min);
Age 18-80 years;
English-speaking.
Exclusion Criteria:
Pre-existing diagnosis of significant dementia or psychosis as determined by primary provider and documented in the medical record;
Corrected visual Acuity >60/20 using a Rosenbaum Pocket Vision Screen;
Patient receives dialysis or has a functional kidney transplant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerri Cavanaugh, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Targeting Social Determinants to Improve Chronic Kidney Disease Care
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