NCT02132013

SodiUm Burden Lowered by Lifestyle Intervention: Self-Management and E-health Technology

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Kidney Disease
• Unspecified Complication of Kidney Transplant

Interventions

Type	Name	Description
BEHAVIORAL	Intervention SUBLIME	Intervention: dietary sodium restriction supported by 2 group meetings, structured self-regulation computer program, e-coaching.

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-12-01
• First posted: 2014-05-06
• Last updated: 2016-05-13

Locations

4 sites across 1 country: Netherlands