Chronic Kidney Disease Clinical Trial
Official title:
SodiUm Burden Lowered by Lifestyle Intervention: Self-Management and E-health Technology
The purpose of this study is to evaluate the effects and efficacy of dietary sodium restriction by mean of a new healthcare approach in patients with chronic kidney disease. The test persons in the intervention group are actively supported to adhere to a restricted sodium diet with a structured self-regulation program to implement sodium recommendations that are in current guidelines.
The intervention entails two group meetings with fellow-patients, motivational interviewing,
e-coaching and ICT-based self-regulation as add-on to regular care. The intervention
consists of a baseline measurement (T0), followed by a preparation phase of 2-3 weeks
duration before the first group meeting. The first group meeting is followed by the action
phase with a second group meeting in 9-11 weeks. During the action phase, test persons are
stimulated to use the special self-regulation computer program, monitor their dietary sodium
intake on this website and receive e-coaching from their personal coach. Test persons in the
control group receive standard care. After 3 months in study (T1), all test persons visit
the outpatient clinic for measurements and data collection. The half year long maintenance
phase starts after this timepoint, test persons in the intervention group can continue the
use of the special website and get feedback from their coach at 3, 4, 5, 6 months. After 9
months of total study duration (T2), data collection and measurements take place.
At each timepoint blood and 24-hourly urine is collected, test persons fill out
questionnaires. The intervention group collects after 5 weeks in study an additional
24-hourly urine collection to assess dietary compliance and enable feedback.
Cost-efficacy and implementation analysis will be conducted after study closure.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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