SodiUm Burden Lowered by Lifestyle Intervention: Self-Management and E-health Technology (SUBLIME)
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|ClinicalTrials.gov Identifier: NCT02132013|
Recruitment Status : Completed
First Posted : May 6, 2014
Last Update Posted : May 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease Unspecified Complication of Kidney Transplant||Behavioral: Intervention SUBLIME||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||SodiUm Burden Lowered by Lifestyle Intervention: Self-Management and E-health Technology|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||December 2015|
Experimental: Intervention SUBLIME
Behavioral: Intervention SUBLIME
Intervention: dietary sodium restriction supported by 2 group meetings, structured self-regulation computer program, e-coaching.
No Intervention: Control
- 24-hourly urinary sodium excretion [ Time Frame: up to 9 months ]
- Blood pressure [ Time Frame: 0, 3, 9 months ]
- Psychological well-being [ Time Frame: 0, 3, 9 months ]Psychological well-being will be assessed with multiple choice questionnaires in all 150 participants.
- Cost-effectiveness [ Time Frame: After study closure ]Cost-effectiveness will be calculated from data derived from questionnaires on health care use (contacts with health care professionals, change in medication) in all participants.
- Tertiary: effect of sodium restriction on cardiorenal biomarkers [ Time Frame: 0, 3 or 9 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02132013
|Almelo, Overijssel, Netherlands, 7609PP|
|Nieuwegein, Utrecht, Netherlands, 3435CM|
|Leiden University Medical Center|
|Leiden, Zuid Holland, Netherlands, 2333ZA|
|University Medical Center Groningen|
|Groningen, Netherlands, 9700RB|
|Study Chair:||Gerjan J Navis, MD PhD||University Medical Center Groningen|
|Principal Investigator:||Paul JM Van der Boog, MD PhD||Leiden University Medical Center|
|Principal Investigator:||Sandra Van Dijk, PhD||Leiden University Medical Center|