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. |