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. 2019 Aug 6;2019(8):CD012379. doi: 10.1002/14651858.CD012379.pub2

SUBLIME 2016.

Methods
  • Study design: parallel RCT

  • Study duration: 3 month intervention, 6 month maintenance phase

  • Study follow‐up: 9 months

Participants
  • Country: Netherlands

  • Setting: outpatients

  • Patients with eGFR > 25mL/min with CKD or kidney transplant recipient; diagnosed with hypertension, sodium intake > 130mmol/day

  • Number: 99, numbers per group not reported

  • Mean age ± SD: 57 ± 12 years

  • Sex: not reported

  • Exclusion criteria: not reported

Interventions
  • Intervention type classification: behavioural counselling

  • eHealth intervention used: website, internet


Intervention group
  • Web‐based self‐management system

    • Dedicated to dietary sodium restriction with individual e‐coaching

    • Two group meetings in 3‐month intervention phase, followed by 6‐month maintenance phase


Control group
  • Not described

Outcomes Outcomes measured at baseline, 3, 6, 9 months
  • BP

  • electrolytes

  • dietary sodium intake (measured using 24 urine collection)

  • QoL and well being

  • Healthcare expenditure from questionnaires

  • Incremental cost‐effectiveness ratio

Notes
  • Abstract‐only publication

  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Study described as randomised, method of random sequence generation not reported
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 Blinding of participants High risk Could not have been blinded
Blinding of participants and personnel (performance bias) 
 Blinding of personnel Unclear risk Insufficient information to permit judgement
Blinding of outcome assessment (detection bias) 
 Objective outcome Low risk Objective data such as BP, 24‐hour urine sodium, cost‐analysis
Blinding of outcome assessment (detection bias) 
 Subjective outcomes Unclear risk No reporting of how well being and quality of life is measured
Incomplete outcome data (attrition bias) 
 All outcomes High risk 28% drop out in intervention, 3.3% drop out in control ‐ no mention if these participants differed; no mention of whether used ITT analyses
Selective reporting (reporting bias) High risk Insufficient information to permit judgement
Other bias Unclear risk Insufficient information to permit judgement