Facilitating Improvements in Kidney Health Using a Smartphone App Counseling Program in Patients With Diabetes
- Conditions
- Chronic Kidney DiseaseDiabetes MellitusAlbuminuria
- Registration Number
- NCT03015480
- Lead Sponsor
- Geisinger Clinic
- Brief Summary
This pilot study tests the feasibility of dietary app-supported tele-counseling in the treatment of patients with stage 1-3a chronic kidney disease (CKD) and diabetes.
- Detailed Description
Patients with diabetes and stage 1-3a CKD receive instructions on downloading and using MyFitnessPal on their smartphone or computer to log meal data daily, weekly website educational materials, and weekly telephone visits with a dietician for 8 weeks. Patients receive a follow-up phone call from the dietitian and 5 and 11 months for further support and counseling, and are also invited to attend a local dietitian-led grocery tour. This pilot study examines the feasibility of dietary app-supported tele-counseling in the treatment of patients with stage 1-3a chronic kidney disease (CKD) and diabetes.
Main outcomes include sodium intake assessed by 24 hour urine collection as well as other dietary measures related to kidney disease (sodium/potassium ratio, Healthy Eating Index score, 24-hour urine phosphorus, estimated net endogenous acid production) and health measures (24-hour ambulatory blood pressure, weight, albumin/creatinine ratio)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Age > 21 years
- Diabetes diagnosis (Type I or Type II)
- Last urine albumin/creatinine ratio (ACR) within the past two years > 30 mg/g
- Last outpatient estimated glomerular filtration rate (eGFR) within the past year > 45 ml/min/1.73m2
- Last outpatient systolic blood pressure (SBP) within the past year < 160 mmHg
- Last outpatient diastolic blood pressure (DBP) within the past year <100 mmHg
- Preceding eGFR decline rate less than -2 ml/min/1.73m2/y
- At least 2 outpatient eGFR measurements in electronic health record, separated by at least 2 years
- Agreeable to change diet (decrease sodium and red/processed meat intake, increase fruit and vegetable intake)
- Access to smartphone or computer
- Inability to understand English
- Myocardial infarction, stroke, or atherosclerotic cardiovascular disease procedure within 6 months.
- Current treatment for malignancy
- Planned bariatric surgery
- Pregnancy or planning to become pregnant within next 2 years
- Self-reported average consumption of > 14 alcoholic beverages per week
- Psychiatric hospitalization in past year
- Unstable angina
- Urine ACR > 2500 mg/g
- Last potassium > 5.0 mg/dL
- Hypoglycemia episode in past 1 month (glucose < 70 mg/dL)
- Principal investigator discretion (i.e. concerns about safety, compliance)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change in 24-hour urine sodium baseline to 12 months unadjusted and adjusted for creatinine excretion
- Secondary Outcome Measures
Name Time Method Change in urine sodium/potassium ratio baseline to 12 months Change in Healthy Eating Index (HEI) score baseline to 12 months Assessed by three 24-hour dietary recalls obtained by phone at each time point
Change in weight baseline to 12 months Change in 24-hour Ambulatory Systolic Blood Pressure baseline to 12 months Change in 24-hour urine phosphorus baseline to 12 months unadjusted and adjusted for creatinine excretion
Change in Net Endogenous Acid Production (NEAP) baseline to 12 months NEAP (mEq/d) = -10.2 + 54.5 (protein \[g/d\]/potassium \[mEq/d\])
Change in 24-hour Urine Albumin Excretion baseline to 12 months unadjusted and adjusted for creatinine excretion
Trial Locations
- Locations (2)
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Geisinger Wyoming Valley Medical Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
Geisinger Medical Center🇺🇸Danville, Pennsylvania, United States