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

InformMe 2017.

Methods
  • Study design: RCT, post‐test‐only control group design; 593 assessed for eligibility, 288 randomised

  • Study duration: October 2013 to December 2014 (site 1); January 2014 to July 2014 (site 2)

  • Study follow‐up: 1 week

Participants
  • Country: USA

  • Setting: outpatient clinic

  • Kidney transplant candidates; aged ≥ 21 years, English speaking, never received a kidney from an IRD, never, rarely, or sometimes need help with written information; willingness to use an iPad 2 tablet

  • Number: intervention group (133); control group (155)

  • Mean age ± SD (years): intervention group (51.2 ± 11.3); control group (50.5 ± 12.3)

  • Sex (M): intervention group (61.1%); control group (62.6%)

  • Exclusion criteria: not reported

Interventions
  • Intervention type classification: education

  • eHealth intervention used: PDA application


Intervention group
  • Inform Me

    • iPad app to improve knowledge about increased risk donor kidneys

    • Using computer adaptive learning method to personalise educational materials and content according to each participants' comprehension level in 5 interactive chapters

    • At the end of each chapter questions to test knowledge with additional education provided if needed

    • Summary reports generated

  • Routine transplant education and clinician visits


Control group
  • Usual care

    • Routine transplant education and clinician visits

Outcomes
  • Knowledge of IRD kidneys 31‐item multiple choice test

  • Willingness to accept hypothetical IRD kidney (5 point Likert scale)

  • Acceptability (open ended questions)

Notes
  • Funding source: "This publication was supported by the NINR/NLM (R21NR013660 to E.J.G.)"

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Using a computer‐generated random number list
Allocation concealment (selection bias) Low risk Sealed envelopes concealed until study arm was assigned
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 High risk Trial was single blinded; research team members assessing outcomes were blinded to assignments to the intervention
Blinding of outcome assessment (detection bias) 
 Objective outcome Low risk No objective outcomes were measured
Blinding of outcome assessment (detection bias) 
 Subjective outcomes Unclear risk Outcomes were subjective and administered by research personnel who could have been made aware of allocation
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 18 people dropped out with no significant differences between them and those who did not drop out but data not shown
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement
Other bias Unclear risk Provided with financial incentives, higher drop‐out/refusal in intervention group; met sample size goal