Skip to main content
. 2019 Aug 6;2019(8):CD012379. doi: 10.1002/14651858.CD012379.pub2

Williams 2017.

Methods
  • Study design: RCT, 31 enrolled and randomised, 29 reported

  • Study duration: 5 weeks

  • Duration of follow‐up: 5 weeks

Participants
  • Country: USA

  • Setting: community, HD unit

  • Adults aged 18 to 75 years receiving maintenance HD for more than 3 months; required to have the ability to walk without assistance or assistive devices to ensure device was able to track activity

  • Number: intervention group (15); control group (14)

  • Mean age ± SD (years): intervention group (56 ± 13); control group (48 ± 15)

  • Sex (M): intervention group (60%); control group (21.4%)

  • Exclusion criteria: unstable health (e.g. acute infections, congestive heart failure NYHA class 4 and/or unstable angina); hospitalised within 3 months before enrolment for non‐access‐related reasons; cognitively impaired; nickel allergy; patients who had previously worn activity tracking devices

Interventions
  • Intervention type classification: self‐monitoring

  • eHealth intervention used: blue‐tooth, electronic monitor


Intervention group
  • Fitbit Flex tracker with feedback

    • As per control group

    • Received a report of activity and sleep data in the week leading to the date of each HD treatment


Control group
  • Fitbit Flex tracker

    • Activity and sleep data collected over the course of 5 weeks

    • Instructed to wear bracelet at all times, even when in water and worn on the non‐vascular access arm.

    • Fitbit Flex tracks activity parameters (steps taken, distance travelled) and sleep duration and quality (minutes asleep, total time in bed)

    • Data downloaded from the device to the user account during each HD treatment

    • Asked to keep a daily sleep log (recorded times they went to bed and the times they woke up)

Outcomes
  • Human activity profile (sleep and physical activity)

  • Physical Activity Questionnaire (regarding participant experience)

  • Laboratory test (obtained from electronic health records) ‐ usual monthly blood tests plus CRP, albumin, pre‐albumin, haemoglobin

  • Clinical parameters: IDWG, blood pressures (pre and post dialysis)

Notes
  • 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 Participants could not have been blinded
Blinding of participants and personnel (performance bias) 
 Blinding of personnel Unclear risk Unclear who provided the feedback to participants
Blinding of outcome assessment (detection bias) 
 Objective outcome Low risk Sleep and physical activity measured objectively
Blinding of outcome assessment (detection bias) 
 Subjective outcomes Low risk No subjective measures, other than patient experience.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 2 participants were not included in analyses as they died during the study period, no mention of which group they were allocated to, however low rate of missing data overall (n = 2; 6%).
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement
Other bias Unclear risk Insufficient information to permit judgement

ACEi ‐ angiotensin‐converting enzyme inhibitor; ACR ‐ albumin:creatinine ratio; ARB ‐ angiotensin receptor blocker; BP ‐ blood pressure; BUN ‐ blood urea nitrogen; CBT ‐ cognitive behaviour therapy; CKD ‐ chronic kidney disease; CrCl ‐ creatinine clearance; CSA ‐ cyclosporin; DBP ‐ diastolic blood pressure; ED ‐ emergency department; eGFR ‐ estimated glomerular filtration rate; EMD ‐ electronic medication dispenser; ESKD ‐ end‐stage kidney disease; HbA1c ‐ haemoglobin A1c (glycated); HD ‐ haemodialysis; HEiQ ‐ Health Education Impact Questionnaire; HRQoL ‐ health‐related quality of life; IDWG ‐ interdialytic weight gain; LDL ‐ low density lipoprotein; MAP ‐ mean arterial pressure; MDRD ‐ Modified Diet in Renal Disease; MEMSI ‐Medication Self‐Management Intervention; PD ‐ peritoneal dialysis; PDA ‐ personal digital assistant; PHR ‐ personal health record; PTH ‐ parathyroid hormone; QoL ‐ quality of life; RCT ‐ randomised controlled trial; SBP ‐ systolic blood pressure; SBP ‐ systolic blood pressure; SCr ‐ serum creatinine; SMS ‐ short messaging service; TAC ‐ tacrolimus; UACR ‐ urine albumin:creatinine ratio; UF ‐ ultrafiltration; VAS ‐ visual analogue scale