The UPBEAT Nurse-Delivered Personalized Care Intervention for People with Coronary Heart Disease Who Report Current Chest Pain and Depression: A Randomised Controlled Pilot Study

Abstract

BackgroundDepression 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.MethodsMulti-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.Result1001 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.ConclusionsTrial and intervention procedures appeared to be feasible and acceptable. PC allowed patients to work on unaddressed problems and appears cheaper than TAU.Trial RegistrationControlled-Trials.com ISRCTN21615909

UPBEAT-UK: a programme of research into the relationship between coronary heart disease and depression in primary care patients

“…We were fortunate to have a National Institute for Health Research-funded statistical fellow attached to our programme and were therefore able to conduct detailed exploratory analyses; these are explained fully in the published report of this study. 110 Essentially, we developed a single statistical model to estimate the difference in mean scores between participants randomised to PC and TAU across the three follow-up points (1, 6 and 12 months). Other exploratory analyses compared the median number of responders (≥ 50% decrease in score from baseline at follow-up) and remitters (score of < 8 at follow-up) according to the HADS-D score between groups and explored changes in self-efficacy, the effect of nurse contact time and therapist effects using t-tests and chi-squared tests.…”

“…110 There were 27 (66%) males in the PC group and 25 (63%) in the TAU group; mean age was 64.2 years (SD 13.0 years) in the PC group and 64.9 years (SD 8.5 years) in the TAU group. Any differences between the groups on the recorded demographic, lifestyle and outcome variables appeared small and the randomisation process appears to have produced balanced groups.…”

“…The study explored the acceptability, feasibility and potential costs of PN-led PC for primary care CHD patients who have depressive symptoms and current chest pain with the overarching aim to test the methods for a definitive trial. The full details of this study have been published in a peer reviewed paper by Barley et al 110 Here we summarise our methods and findings and report additional exploratory analyses.…”

“…The protocol for the study has been published; 111 deviations from the protocol are explained in the published report of this study. 110 The study was reviewed and approved by the south-east London Research Ethics Committee (reference 10/H0808/5) and is registered with Current Controlled Trials International Standard Randomised Controlled Trial Number 21615909. The UPBEAT-UK Programme Grant Steering Committee, who decided that a data monitoring committee would not be necessary, oversaw the study.…”

“…110 By 12 months, six people in the intervention group had dropped out (two because they found participation upsetting, two because they felt too physically unwell to continue and two gave no reason) and one from the control group had dropped out (because they found participation upsetting). Two intervention group participants received baseline assessment but no intervention, as the nurses were unable to contact them.…”