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Effect of a Hypertension-Management App "CureApp HT" on Urinary Sodium Excretion in CKD Patients: A Randomized Controlled Trial (CureApp HT CKD Trial)

CureApp HT CKD Trial (CureApp HT CKD Trial)

101

The mean (standard deviation) or median [interquartile range] values of baseline characteristics in the intervention group (n=51), and control group (n=50) are described below. age: 67 (14), 66 (14) sex (male): 29 (57%), 34 (68%) diabetes mellitus: 15 (29%), 21 (42%) systolic blood pressure, mmHg: 128 (20), 134 (16) diastolic blood pressure, mmHg: 79 (15), 79 (14) BMI, kg/m^2: 23.9 (3.7), 23.9 (3.5) creatinine, mg/dL: 1.8 (1.1), 1.5 (0.6) eGFR, ml/min/1.73 m^2: 35.4 (17.6), 40.0 (17.8) albumin, g/dL: 4.0 (0.3), 4.1 (0.4) UPCR, g/gCre: 0.28 [0.09, 0.97], 0.27 [0.10, 0.53] BNP, pg/mL: 27 [9, 43], 34 [15, 69] estimated 24-hour urinary sodium excretion, mmol: 143 (29), 147 (37)

Among 101 participants, 9 dropped out from the study.In the intervention group, three patients refused to use the app, and two withdrew consent. In the control group, one patient died, two withdrew consent.

None

Primary Outcome Change (SD) in estimated 24-hour urinary sodium excretion from baseline to 12 weeks was 1.4 (6.8) and 2.3 (6.7) mmol in the intervention and control groups, respectively. No significant differences between groups were detected (change, -0.9 mmol in the intervention group, 95% confidence interval, -19.7 to 17.8, P=0.9). Secondary Outcome No significant group differences were found for all secondary outcomes (office blood pressure, brachial-ankle pulse wave velocity, urinary protein-to-creatinine ratio, urinary potassium-to-creatinine ratio, urinary sodium-to-potassium ratio, eGFR, brain natriuretic peptide, body weight, and the number of antihypertensive medications).

This RCT investigated the efficacy of CureApp HT for salt reduction in CKD patients. We observed substantial improvement in self-reported salt intake behaviors in the intervention group. However, the app did not improve estimated 24-hour urinary sodium excretion, a surrogate measure of actual salt. The app's low intervention intensity, with limited healthcare provider involvement, may have contributed to this gap between intention and behavior. More interactive, personalized interventions would be needed.

Oct. 01, 2024

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs052220164

Sakaguchi Yusuke

Osaka University Hospital

2-15 Yamadaoka Suita Osaka, Japan

sakaguchi@kid.med.osaka-u.ac.jp

Sakaguchi Yusuke

Osaka University Hospital

2-15 Yamadaoka Suita Osaka, Japan

+81-6-6879-3857

sakaguchi@kid.med.osaka-u.ac.jp

Complete

Feb. 13, 2023

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1) Age 18 years or older
2) CKD stage1 to 5 patients referred to the outpatient department of nephrology at Osaka University Hospital
3) History of hypertension (the systolic blood pressure is >=140 mmHg and/or the diastolic blood pressure is >=90 mmHg) and/or prescription of antihypertensive drugs
4) Urinary sodium excretion >=100 mmol/day
5) Written informed consent

1) Use of other healthcare applications
2) Inability to use the application (by the patient or family members)

Both

Chronic Kidney Disease

1. Intervention Group
Use of CureApp HT for 12 weeks + Usual lifestyle modification
2. Control Group
Usual lifestyle modification

Chronic Kidney Disease

Digital Therapeutics, Salt restriction, Behavioral intervention

Kidney Failure, Chronic

Self-Management* / education

Change in 24-hour urinary sodium excretion

1) Office blood pressure
2) Pulse wave velocity
3) Urinary protein creatinine ratio
4) Urinary potassium creatinine ratio
5) Urinary sodium potassium ratio
6) estimated Glomerular Filtration Rate
7) Brain natriuretic peptide
8) Body weight
9) Dose of antihypertensive drugs
10) Adverse events

+81-6-6210-8296

Jan. 24, 2023

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