Objective To assess the clinical and cost-effectiveness of a brief home based cognitive behavioural rehabilitation programme (the ICD-Plan) for patients undergoing implantation of a cardiac defibrillator.
Design A prospective multicentred, intention-to-treat cluster randomised controlled trial.
Setting Eight Implantable Cardioverter Defibrillator (ICD) implantation centres in the UK.
Patients Consecutive series of patients undergoing implantation with an ICD.
Interventions The control group received usual care and advice from an appropriately qualified and experienced healthcare professional (ECG physiologist or arrhythmia nurse specialist). The intervention group received usual care plus the ICD-Plan. This was introduced to the patient prior to implantation and there were three further brief contacts over the next 12 weeks through a 10-20 minute telephone call from the nurse.
Main outcome measures Health Related Quality of Life (Short Form Health Survey,SF-12), Anxiety and Depression (Hospital Anxiety & Depression Scale, HADS), Activity Limitations (sub-scale from the Seattle Angina Questionnaire, SAQ), unplanned admissions and other economic data using a questionnaire developed for the study.
Results A total of 192 patients were recruited to the study (71 intervention and 121 control). At six months post surgery the intervention group had better physical health (37.83 vs 34.24; p<0.01), fewer limitations in physical activity (34.02 vs 31.72; p=0.04), a greater reduction in the proportion of patient with a borderline diagnosis of anxiety 21% vs 13%; p= 0.60) and depression (13% vs 2%; p=0.30), more planned ECGs (89% vs 66%; p=0.04), and 50% fewer unplanned admissions (11% vs 22%; p<0.01).
Conclusions The ICD-Plan improved health related quality of life, reduced the incidence of clinically significant psychological distress, and significantly reduced unplanned re-admissions. It is a cost effective and easily implemented method for delivering rehabilitation and psychological care to patients undergoing ICD implantation. [Trial registry and Registration Number: International Standard Randomised Controlled Trial Number 70212111]
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