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

NCT ID: NCT02132013

Last Updated: 2016-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention SUBLIME

Intervention group

Group Type: EXPERIMENTAL

Intervention SUBLIME

Intervention Type: BEHAVIORAL

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

Control

Regular care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intervention SUBLIME

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Be 18 years or older.
• Have chronic kidney disease (CKD stage 1-3, CKD 4 if eGFR is not lower than 25 mL/min/1.73m2, or be a renal transplant recipient.)
• Have a urinary sodium excretion during at least the last 2 subsequent visits of more than 130 mmol per day, or one last urinary sodium excretion of more than 150 mmol per day.
• Have a systolic blood pressure higher than 135 mmHg, diastolic blood pressure higher than 85 mmHg or a well-controlled blood pressure by treatment with antihypertensives including RAAS-blockade (ACE-inhibitor or ARB).
• Sufficient command of the Dutch language.
• Access and ability to use the internet.
• Written informed consent.

Exclusion Criteria

• eGFR < 25 ml/min/1.73m2 or an anticipated need for predialysis work-up within the time frame of the study.
• Unstable disease: defined as rapid, persistent, progressive renal function loss (e.g. > 6 mL/min/1.73m2 per year), not from acute, intermittent origin.
• Blood pressure > 170 mmHg systolic or > 100 mmHg diastolic during medical treatment
• Blood pressure < 95 mmHg systolic not responding to withdrawal of antihypertensives.
• Cardiovascular event (myocardial infarction, cerebrovascular accident) < 6 months ago.
• Renal transplantation <1 year ago.
• Medical conditions that are likely to interfere with completion of the study (such as progressive malignancy or other debilitating illness) at the discretion of the nephrologist.
• Every patient who has participated in the ESMO study (regardless whether intervention or control) cannot participate in the current study.
• Current participation in any clinical trial that might interfere with SUBLIME trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dutch Kidney Foundation

OTHER

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: collaborator

St. Antonius Hospital

OTHER

Sponsor Role: collaborator

Ziekenhuisgroep Twente

OTHER

Sponsor Role: collaborator

TNO

OTHER

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

prof.dr. G.J. Navis

prof.dr. G.J. Navis

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerjan J Navis, MD PhD

Role: STUDY_CHAIR

University Medical Center Groningen

Paul JM Van der Boog, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Sandra Van Dijk, PhD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

Ziekenhuisgroep Twente

Almelo, Overijssel, Netherlands

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Leiden University Medical Center

Leiden, South Holland, Netherlands

St. Antonius

Nieuwegein, Utrecht, Netherlands

Countries

Netherlands

References

McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.pub3.

Reference Type: DERIVED

PMID: 34164803 (View on PubMed)

Humalda JK, Klaassen G, de Vries H, Meuleman Y, Verschuur LC, Straathof EJM, Laverman GD, Bos WJW, van der Boog PJM, Vermeulen KM, Blanson Henkemans OA, Otten W, de Borst MH, van Dijk S, Navis GJ; SUBLIME Investigators. A Self-management Approach for Dietary Sodium Restriction in Patients With CKD: A Randomized Controlled Trial. Am J Kidney Dis. 2020 Jun;75(6):847-856. doi: 10.1053/j.ajkd.2019.10.012. Epub 2020 Jan 16.

Reference Type: DERIVED

PMID: 31955921 (View on PubMed)

Other Identifiers

METC 2014/075

Identifier Type: OTHER

Identifier Source: secondary_id

837001005

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NL48079.042.14

Identifier Type: -

Identifier Source: org_study_id