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

BRIGHT 2013.

Methods

  • Study design: pragmatic, two‐arm, patient‐level RCT; 637 assessed for eligibility, 440 randomised

  • Study duration: April 2012 to November 2012

  • Duration of follow‐up: 6 months
Participants

  • Country: UK

  • Setting: multicentre (24 sites)

  • Stage 3 CKD with or without proteinuria

  • Number (randomised/self‐reported data/BP data): intervention group (215/180/193); control group (221/194/210)

  • Mean age ± SD (years): intervention group (72.4 ± 9.2); control group (71.8 ± 9.0)

  • Sex (M/F): intervention group (90/125); control group (91/130)

  • Exclusion criteria: unable to communicate in English; had reduced capacity to provide informed consent or were in receipt of palliative care
Interventions

  • Intervention type classification: behavioural counselling

  • eHealth intervention used: Telehealth


Intervention group

  • BRIGHT intervention (participants could use resources at their discretion)

    • A kidney information guidebook.

    • PLANS (patient‐led assessment for networks support) booklet and access to an interactive website with tailored access to local resources.

    • Telephone support from a dedicated peer support worker 2 telephone calls from lay health workers (week 1, week 5)


Control group

  • Usual care

    • Offer kidney guidebook at end of study

    • No other description
Outcomes Primary outcomes measured at baseline and 6 months

  • Blood pressure: dichotomised as “controlled” versus poorly controlled in accordance with 2008 NICE guidelines; <140/90 for those without proteinuria, <130/80 for those with proteinuria

  • Self‐management: “The positive and Active Engagement in Life” domain of the validated HEiQ

  • HQoL: measured using EuroQoL EQ‐5D


Secondary outcomes measured at baseline and 6 months

  • Health status

  • Anxiety (general and CKD‐specific)

  • Loneliness

  • Medication adherence

  • Social networks

  • Social involvement

  • Service utilisation and resource use for cost‐effectiveness analysis


Intervention uptake and evaluation measured at 6 months

  • Self‐reported Intervention uptake and evaluation – kidney guidebook

  • Self‐reported Intervention uptake and evaluation – PLANS website and booklet

  • Self‐reported Intervention uptake and evaluation – telephone support call uptake
Notes

  • Funding source: "The study was conducted as part of the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) Greater Manchester"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Patient will be allocated to a trial arm via a minimization algorithm (incorporating a random component)
Allocation concealment (selection bias) Low risk Allocation adequately concealed using central allocation
Blinding of participants and personnel (performance bias) 
 Blinding of participants High risk Quote: "Neither researchers or participants were blinded"
Blinding of participants and personnel (performance bias) 
 Blinding of personnel High risk Quote: "Neither researchers or participants were blinded"
Blinding of outcome assessment (detection bias) 
 Objective outcome Low risk Objective measures at low risk of bias
Blinding of outcome assessment (detection bias) 
 Subjective outcomes High risk Subjective measures self‐report questionnaires filled out by unblinded participants
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Intervention Self‐Report: 16.2% loss to follow‐up
Intervention BP: 9.4% loss to follow‐up; intention‐to‐treat analyses
Selective reporting (reporting bias) Low risk All outcomes stated in the protocol were reported
Other bias Low risk No other biases detected