Table 4.

Summary of the TREAT randomised controlled trial.

Trial No	ISRCTN93952605
Target group	N Randomised: 46 intervention vs. 51 usual care Diagnosis: Warfarin-naive AF patients Demographics of cohort: Mean (SD) age 72.9 (8.2) years; 64.9% male; 99% White British, Irish or European. No significant differences in demographic variable between groups. Inclusion/exclusion criteria: AF patients newly referred for warfarin therapy, with ECG-documented AF, will be eligible for inclusion. Patients were excluded if they were aged <18 years old, had any contraindication to warfarin, had previously received warfarin, had valvular heart disease, cognitively impaired, unable to speak or read English or had any disease likely to cause their death within 12 months.
Intervention	Type: One-off group [1–6 patients] theory-driven educational intervention Content: DVD, educational booklet, worksheet, group discussion. Duration: 1 h session Facilitator: Health-Psychologist (could be delivered by trained lay educator) Setting: Hospital outpatients clinic
Outcomes	Primary outcome: Time within therapeutic range (TTR) calculated using the Rosendaal method Secondary outcomes: Patient knowledge, Beliefs about Medication, Quality of Life, Anxiety and Depression, Hospital Admissions and Adverse events.
Comparison group	Usual Hospital Care
Random sequence generation	A computer generated list stratified by (a) age (<70 and ≥70 years)/sex and (b) specialist AF clinic versus ‘general’ cardiology clinic, in blocks of four, randomised patients on an individual basis to receive either ‘usual care’ or the intensive educational intervention, in addition to ‘usual care’. The randomisation schedule was designed by an independent trials unit.
Blinding	A researcher not involved in the data analysis or intervention delivery matched patient ID numbers with randomisation codes and checked follow-up questionnaires for completeness. The researcher analysing the data was blinded to which arm of the intervention patients were randomised to.