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

Kullgren 2015.

Methods
  • Study design: RCT; 40 eligible, 32 randomised

  • Study duration: 4 weeks

  • Study follow‐up: 4 weeks

Participants
  • Country: USA

  • Setting: community

  • Paediatric transplant recipients

  • Number: intervention group (16); control group (16)

  • Mean age ± SD (years): 13.8± 5.4 years

  • Sex (F): 44%

  • Exclusion criteria: family did not speak English or if the child’s cognitive functioning would interfere with their ability to participate

Interventions
  • Intervention type classification: self‐monitoring

  • eHealth intervention used: blue‐tooth, electronic monitor


Intervention group
  • Interactive water bottle

    • Recall fluid intake for 3 days prior to commencement of study via a log and to keep daily diaries

    • Calculates personal hydration needs, tracks real time fluid intake pacing throughout the day.

    • Participant enters weight and bottle automatically calculates fluid requirements, this can be adjusted manually.

    • HydraCoach prompts user to drink by continuously visually displaying% consumed in litres or ounces

  • Standard care


Control group
  • Standard care

    • Recall fluid intake for 3 days prior to commencement of study via a log and to keep daily diaries

    • Given written information regarding fluid target and choices.

Outcomes Outcome measures assessed at baseline and 1 month
  • Fluid intake (Self‐reported ‐ reported intake, fluid goal achieved, fluid intake tracking ‐ diary)

  • Biochemistry (BUN, sodium, creatinine ‐ % change over the study period)

Notes
  • Funding source: St. Louis Children’s Hospital Nursing Research Grant and the University of Michigan Charles Woodson Fund for Clinical Research

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Block randomisation
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 Blinding of participants High risk Blinding not possible
Blinding of participants and personnel (performance bias) 
 Blinding of personnel Unclear risk No reporting of blinding of personnel
Blinding of outcome assessment (detection bias) 
 Objective outcome Low risk Biochemical measures of creatinine, BUN and sodium are objective
Blinding of outcome assessment (detection bias) 
 Subjective outcomes High risk Self‐reported measure
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No reported loss to follow up or incomplete diaries
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement
Other bias High risk small sample size ‐ population not generalisable, limited follow‐up time, control and intervention groups significantly different with respect to time since transplant, low uptake rate of the intervention