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

Li 2014b.

Methods
  • Study design: RCT; 186 assessed for eligibility,160 participants randomised

  • Study duration: 6 weeks

  • Study follow‐up: 12 weeks

Participants
  • Country: China

  • Setting: community, dialysis unit

  • Maintenance PD patients

  • Number (randomised/completed): intervention group (80/69); control group (80/66)

  • Mean age ± SD (years): intervention group (57.4 ± 12.8); control group (55.2 ± 11.9)

  • Sex (M/F): intervention group (42/27); control group (37/29)

  • Exclusion criteria: Tenchkoff catheters in situ for less than 3 months; receiving intermittent PD or HD and those with planned admissions for special treatment procedures; psychosis or dementia; dying or unable to communicate; being transferred to another unit during their hospital stay

Interventions
  • Intervention type classification: behavioural counselling

  • eHealth intervention used: Telehealth


Intervention group
  • Telephone support

    • Comprehensive discharge planning protocol prior to discharge and standardised 6‐week post‐discharge nurse‐led telephone support intervention

    • Patients physical, social, cognitive and emotional needs assessed and comprehensively and individualised education program conducted prior to discharge

    • After discharge nurse case managers began telephone contact with patients weekly for 6 consecutive weeks. First call within first 72 hours after discharge to assess status and give advice

    • Content of each telephone call guided by the protocol and specific problems identified in predischarge assessment

    • Case manager discussed issues patients encountered and if necessary made appropriate referrals


Control group
  • Standard care

    • Talking to doctor about special points that need attention when returning home

    • Telephone hotline service

    • Set of free self‐help printed materials on maintaining healthy lifestyle

    • Reminder to attend outpatient appointments

Outcomes
  • QoL: KDQoL‐SF (baseline, 6 weeks, 12 weeks)

  • Complications (oedema, weight gain, peritonitis, catheter infections, biochemistry (urea, creatinine, sodium, K, PO4, albumin), self reported and validated against hospital records (measured weeks 6‐12)

  • Healthcare utilisation: self reported and hospital records (days between index discharge and readmission were extracted from the hospital information systems) (measured weeks 6‐12)

Notes
  • Funding source: "partly supported by Outstanding young talents training project of Guangdong Province (Grant No. LYM11035) and the Guangdong Natural Science Foundation, China (Grant No. S2011040005590)"

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated numbers
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 Blinding of participants High risk Unable to be blinded
Blinding of participants and personnel (performance bias) 
 Blinding of personnel Unclear risk No mention but probably not blinded because of nature of intervention
Blinding of outcome assessment (detection bias) 
 Objective outcome Low risk Hospital records are objective
Blinding of outcome assessment (detection bias) 
 Subjective outcomes Unclear risk No mention of whether blinded, some measures (QoL) used validated measures, while others (health service utilisation) was self‐reported
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Dropout (13.7% to 17.5%), no mention of whether these drop outs significantly different; only those with full outcome data included in study; reasons for drop outs similar across both groups
Selective reporting (reporting bias) High risk Insufficient information to permit judgement
Other bias High risk Small sample size, short duration ‐ not generalisable under powered