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

Ishani 2016.

Methods
  • Study design: parallel RCT (3:1 randomisation); 4105 eligible, 601 randomised

  • Study duration: March 2012 to November 2013

  • Study follow‐up: 12 months

Participants
  • Country: USA

  • Setting: community

  • CKD (eGFR < 60 mL/min)

  • Number: intervention group (450); control group (150)

  • Mean age ± SD (years): intervention group (75.3 ± 8.1); control group (74.3 ± 8.1)

  • Sex (M): intervention group (98.7%); control group (98.0%)

  • Exclusion criteria: unable to give consent; had life expectancy less than 1 year; lived in a skilled nursing facility; had a primary care provider unwilling to allow participation

Interventions
  • Intervention type classification: behavioural counselling

  • eHealth intervention used: Telehealth


Intervention group
  • Telehealth

    • Video monitoring device with peripherals and broadband installed in home and participants trained to use device and peripherals (BP cuff, scale, glucometer, pulse oximeter, stethoscope, web camera) and how to contact team

    • Interprofessional team (nephrologists, nurse practitioner, clinical pharmacy specialist, psychologist, social worker, Telehealth care technician, dietitian) reviewed patient and developed patient‐specific treatment plan addressing short and long term goals.

    • Specific issues addressed included management of BP, volume status, proteinuria, DM, lipid levels, depression, HL, patient activation, lifestyle modification (physical activity, diet, weight reduction, smoking cessation) Education delivered over broadband device.

    • Patients could interact with learning modules at their own pace.

    • Vital signs automatically measured by device and transmitted to study team reviewed every 30 days by health team, Reviewed by study team every 3 months


Control group
  • Usual care

    • Invited to attend CKD education class and to follow primary care providers regarding kidney disease management

    • Exact care not investigated

Outcomes Primary outcome (measured at 12 months)
  • Composite of death, hospitalisation, ED visits and admission to skilled nursing facility


Secondary outcomes (measured at 12 months)
  • Incidence of ESKD

  • Death

  • Hospitalisation (rate and length of 1st admission)

  • ED visits

  • Admission to skilled nursing facility


Intermediate study outcomes (measured at 12 months)
  • SBP

  • LDL cholesterol

  • HbA1c

Notes
  • Systolic BP higher in intervention at baseline, racial differences between groups at baseline

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomly assigned to receive the intervention or usual care using a centralized computer‐generated randomization scheme using permuted block sizes of 2, 4, or 6. Randomization was stratified by eGFR (<30 vs >30 mL/min/1.73 m2), presence of diabetes, and occurrence of a hospitalization in the past year"
Allocation concealment (selection bias) Low risk Quote: "Randomization occurred over the telephone by an individual blinded to patient identity"
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 Likely blinding would have been broken
Blinding of outcome assessment (detection bias) 
 Objective outcome Low risk Outcome assessors were blinded. all outcomes were objective
Blinding of outcome assessment (detection bias) 
 Subjective outcomes Low risk No subjective outcomes were measured
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Only 1 participant (of 601) withdrew consent; used intention‐to‐treat analyses
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement
Other bias Unclear risk baseline characteristics between groups similar, limited generalisability possible due to high proportion of men, met sample size calculation for power