Skip to main content
. 2018 Aug 16;4:140. doi: 10.1186/s40814-018-0330-4

Table 1.

Trial summary

Data category Information
Primary registry and trial identifying number ISRCTN36257982
Date of registration in primary registry 06/01/2016
Secondary identifying numbers REC: 17/NE/0093
Funder Reference: 14/42/01
Source(s) of monetary or material support National Institute for Health Research Health Technology Assessment
Primary sponsor Newcastle upon Tyne Hospitals NHS Foundation Trust
Secondary sponsor(s) N/A
Contact for public queries Miss Nicola Goudie
Newcastle Clinical Trials Unit
Newcastle University
1–4 Claremont Terrace
Newcastle upon Tyne
NE2 4AE
United Kingdom
Contact for scientific queries Miss Nicola Goudie
Newcastle Clinical Trials Unit
Newcastle University
1–4 Claremont Terrace
Newcastle upon Tyne
NE2 4AE
United Kingdom
Public title Preoperative Behavioural Intervention to Reduce Drinking before elective orthopaedic Surgery
Scientific title Preoperative Behavioural Intervention to Reduce Drinking before elective orthopaedic Surgery
Countries of recruitment England
Health condition(s) or problem(s) studied Preoperative alcohol consumption
Intervention(s) Intervention: Preoperative Brief Behavioural Intervention to reduce or cease drinking in elective orthopaedic patients
Comparator: Treatment as Usual
Key inclusion and exclusion criteria Ages eligible for study: ≥18 years
Sexes eligible for study: both
Accepts healthy volunteers: no
Inclusion criteria: adult patient (≥ 18 years), listed for primary elective joint (hip or knee) arthroplasty, AUDIT C score ≥ 5 or report consuming 6 units or more in one session at least weekly with the capacity to provide informed written consent and able to write and converse in English
Exclusion criteria: Patients likely to undergo sequential joint replacements within the duration of the study, those displaying current (active) withdrawal from alcohol, those with severe psychiatric disorder requiring medical treatment, cognitive impairments or dementia impacting ability to interact with the intervention
Study type Interventional
Allocation: randomised (1:1)
Intervention model: parallel assignment
Masking: non blinded
Date of first enrolment N/A
Target sample size 80
Recruitment status Recruitment to commence June 2017
Primary outcome(s) Number of patients screened, and the percentages of eligible patients recruited and retained at 6-month follow-up.
Key secondary outcomes Alcohol consumption: full AUDIT score
Health Related Quality of Life: The EQ-5D
Major and minor postoperative complications: Clavien-Dindo classification; Postoperative Morbidity Survey (POMS)
Joint functionality: Western Ontario and McMaster Universities osteoarthritis index (WOMAC) Functional Assessment score.