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

Navaneethan 2017.

Methods

  • Study design: parallel RCT; 485 assessed for eligibility, 209 randomised

  • Study duration: July 2012 to December 2013

  • Study follow‐up: 2 years
Participants

  • Country: USA

  • Setting: community

  • English‐speaking adults aged 18–80 years with an eGFR 15–45 mL/min/1.73 m2

  • Number: intervention group (50); control group (57)

  • Median age; IQR (years): intervention group (67; 61, 72); control group (68; 64, 72)

  • Sex (F): intervention group (50%); control group (68%)

  • Exclusion criteria: kidney transplant recipients; patients on dialysis, patients with terminal illness or cancer
Interventions

  • Intervention type classification: self‐monitoring, behavioural counselling and self‐monitoring with education

  • eHealth intervention used: Internet, website


Intervention group

  • Enhanced personal health records (self‐monitoring and education)

    • The E‐PHR functionality was developed with the assistance of Cleveland Clinic’s Information Technology Division MyChart team to securely review CKD education materials. These features were in addition to the existing features available to all PHR users.

    • CKD alert appeared only once, and when the patient clicked on the alert, it led them to the page that provided details for CKD. Educational resources were adapted from local and national resources, including education materials covering topics like nutrition and physical activity, complications of CKD, co‐morbidity management and planning for dialysis.


Control group

  • Usual care (self‐monitoring)

    • Advised to use their PHR (MyChart account via EPIC [Madison,WI]) accounts to aid in the management of their health. No specific changes to their PHR accounts were made.

    • All patients who use the PHR can review and schedule appointments, request prescription renewals, view health summaries, access a current list of medications, review test results, and send a secure message to their physicians or health care team. Patients also receive automated important health reminders on the basis of sex‐ and age‐based health maintenance schedules as well as chronic disease–related reminders.

    • Links within the PHR allow patients to access reliable health information about a broad range of topics of personal interest through a third‐party vendor (MedlinePlus).
Outcomes Primary outcome
Change in eGFR
Secondary outcomes

  • Acquisition of appropriate laboratory measures: Hb, phosphorus, UACR, 25‐hydroxy vitamin D, PTH, LDL‐cholesterol, HbA1c

  • Prescription of renoprotective medications (i.e. ACEi and ARB)

  • Referral rates to nephrologists, vascular surgeons and for kidney transplantation assessment

  • Achieving BP control, < 130/80 mmHg

  • Number of hospitalisations and ED visits

  • Death
Notes

  • 75% of study populations were white

  • Funding source: "This clinical trial was supported by grant R34DK094112 from the National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases. The creation of the Cleveland Clinic CKD registry was funded by an unrestricted grant from Amgen, Inc. (to the Department of Nephrology and Hypertension Research and Education Fund, Cleveland Clinic)"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated randomisation scheme that was stratified by family health centre
Allocation concealment (selection bias) Unclear risk Quote: "Randomization allocation was concealed" however not detail on how this was achieved
Blinding of participants and personnel (performance bias) 
 Blinding of participants High risk Quote: "Participants were aware of their assignment"
Blinding of participants and personnel (performance bias) 
 Blinding of personnel Low risk Quote: "Study personnel (study coordinator and the navigators) were aware of their assignment, but the outcome assessors were not aware of the study assignments".
Blinding of outcome assessment (detection bias) 
 Objective outcome Low risk All outcomes are objective and at low risk of bias
Blinding of outcome assessment (detection bias) 
 Subjective outcomes Low risk No subjective measures being used
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No loss to follow‐up
Selective reporting (reporting bias) Low risk All stated outcomes have been reported
Other bias High risk "We did not power the study specifically to estimate the interaction of the two interventions"