A pilot randomised controlled trial of personalised care for depressed patients with symptomatic coronary heart disease in South London general practices: the UPBEAT-UK RCT protocol and recruitment

Abstract

BackgroundCommunity studies reveal people with coronary heart disease (CHD) are twice as likely to be depressed as the general population and that this co-morbidity negatively affects the course and outcome of both conditions. There is evidence for the efficacy of collaborative care and case management for depression treatment, and whilst NICE guidelines recommend these approaches only where depression has not responded to psychological, pharmacological, or combined treatments, these care approaches may be particularly relevant to the needs of people with CHD and depression in the earlier stages of stepped care in primary care settings.MethodsThis pilot randomised controlled trial will evaluate whether a simple intervention involving a personalised care plan, elements of case management and regular telephone review is a feasible and acceptable intervention that leads to better mental and physical health outcomes for these patients. The comparator group will be usual general practitioner (GP) care.81 participants have been recruited from CHD registers of 15 South London general practices. Eligible participants have probable major depression identified by a score of ≥8 on the Hospital Anxiety and Depression Scale depression subscale (HADS-D) together with symptomatic CHD identified using the Modified Rose Angina Questionnaire.Consenting participants are randomly allocated to usual care or the personalised care intervention which involves a comprehensive assessment of each participant’s physical and mental health needs which are documented in a care plan, followed by regular telephone reviews by the case manager over a 6-month period. At each review, the intervention participant’s mood, function and identified problems are reviewed and the case manager uses evidence based behaviour change techniques to facilitate achievement of goals specified by the patient with the aim of increasing the patient’s self efficacy to solve their problems.Depressive symptoms measured by HADS score will be collected at baseline and 1, 6- and 12 months post randomisation. Other outcomes include CHD symptoms, quality of life, wellbeing and health service utilisation.DiscussionThis practical and patient-focused intervention is potentially an effective and accessible approach to the health and social care needs of people with depression and CHD in primary care.Trial registrationISRCTN21615909.

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

“…The study protocol has been published [16] and the pilot trial is registered with Current Controlled Trials: ISRCTN 21615909.…”

Unresolved issues in the management of chronic stable angina

“…Tylee et al report that patients in south London with CAD are twice as likely to be depressed as the general population and that this co-morbidity affects outcome [19]. Patients in south London with depression and symptomatic CAD, as identified using the Rose Angina Questionnaire, are currently being recruited for a randomised controlled trial (RCT) of additional versus standard general practice care [19].…”

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

“…111 There was no evidence for an interaction between time point and study arm for any outcome, so a differential effect over time appears unlikely.…”

“…We have published patient recruitment details in a paper by Tylee et al 111 We summarise it briefly here. Of the 3325 people on the 17 GP CHD registers, 1001 consented to be contacted by returning a letter to their GP.…”

“…We compared PN-led PC plus TAU for 6 months with TAU alone. 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.…”