Clinical trial NCT03015480: Facilitating Improvements in Kidney Health Using a Smartphone App Counseling Program in Patients With Diabetes
Official title: Facilitating Improvements in Kidney Health Using a Smartphone App Counseling Program in Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Diabetes Mellitus
Albuminuria
Keywords: Mobile Application
Chronic Kidney Disease
Diabetes Mellitus
Albuminuria
Diet
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2017-01-10
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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)

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change in 24-hour urine sodium
timeFrame: baseline to 12 months
Secondary outcomes:
measure: Change in 24-hour Ambulatory Systolic Blood Pressure
timeFrame: baseline to 12 months
measure: Change in urine sodium/potassium ratio
timeFrame: baseline to 12 months
measure: Change in Healthy Eating Index (HEI) score
timeFrame: baseline to 12 months
measure: Change in 24-hour Urine Albumin Excretion
timeFrame: baseline to 12 months
measure: Change in weight
timeFrame: baseline to 12 months
measure: Change in 24-hour urine phosphorus
timeFrame: baseline to 12 months
measure: Change in Net Endogenous Acid Production (NEAP)
timeFrame: baseline to 12 months
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley Medical Center
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Alex Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schrauben SJ, Inamdar A, Yule C, Kwiecien S, Krekel C, Collins C, Anderson C, Bailey-Davis L, Chang AR. Effects of Dietary App-Supported Tele-Counseling on Sodium Intake, Diet Quality, and Blood Pressure in Patients With Diabetes and Kidney Disease. J Ren Nutr. 2022 Jan;32(1):39-50. doi: 10.1053/j.jrn.2021.08.006. Epub 2021 Oct 11.