Abstract
Background: Depression is common in people with coronary heart disease (CHD) and associated with worse outcome. This study explored the acceptability and feasibility of procedures for a trial and for an intervention, including its potential costs, to inform a definitive randomized controlled trial (RCT) of a nurse-led personalised care intervention for primary care CHD patients with current chest pain and probable depression. Methods: Multi-centre, outcome assessor-blinded, randomized parallel group study. CHD patients reporting chest pain and scoring 8 or more on the HADS were randomized to personalized care (PC) or treatment as usual (TAU) for 6 months and followed for 1 year. Primary outcome was acceptability and feasibility of procedures; secondary outcomes included mood, chest pain, functional status, well being and psychological process variables. Result: 1001 people from 17 General Practice CHD registers in South London consented to be contacted; out of 126 who were potentially eligible, 81 (35% female, mean age = 65 SD11 years) were randomized. PC participants (n = 41) identified wide ranging problems to work on with nurse-case managers. Good acceptability and feasibility was indicated by low attrition (9%), high engagement and minimal nurse time used (mean/SD = 78/19 mins assessment, 125/91 mins telephone follow up). Both groups improved on all outcomes. The largest between group difference was in the proportion no longer reporting chest pain (PC 37% vs TAU 18%; mixed effects model OR 2.21 95% CI 0.69, 7.03). Some evidence was seen that self efficacy (mean scale increase of 2.5 vs 0.9) and illness perceptions (mean scale increase of 7.8 vs 2.5) had improved in PC vs TAU participants at 1 year. PC appeared to be more cost effective up to a QALY threshold of approximately £3,000. Conclusions: Trial and intervention procedures appeared to be feasible and acceptable. PC allowed patients to work on unaddressed problems and appears cheaper than TAU. Trial Registration: Controlled-Trials.com ISRCTN21615909. © 2014 barley et al.