A brief cognitive behavioural preimplantation and rehabilitation programme for patients receiving an implantable cardioverter-defibrillator improves physical health and reduces psychological morbidity and unplanned readmissions.

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 experienced healthcare professional. The intervention group received usual care plus the ICD Plan. The plan was introduced before implantation, with three further brief telephone contacts with the nurse over the next 12 weeks. MAIN OUTCOME MEASURES: Health-related quality of life (Short Form Health Survey (SF-12)), anxiety and depression (Hospital Anxiety and Depression Scale (HADS)), activity limitations (subscale from the Seattle Angina Questionnaire (SAQ)), unplanned admissions and other economic data using a questionnaire developed for the study. RESULTS: 192 patients were recruited to the study (71 intervention, 121 control). At 6 months after 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 patients 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 readmissions. It is a cost effective and easily implemented method for delivering rehabilitation and psychological care to patients undergoing ICD implantation. TRIAL REGISTRATION NUMBER: ISRCTN70212111.

Development of a measure of the concerns held by people with implanted cardioverter defibrillators: the ICDC.

OBJECTIVES: To develop a questionnaire to measure the extent and severity of the concerns of people with an implanted cardioverter defibrillator. DESIGN: Items were generated from patient interviews, expert review and the research literature on patients' worries and concerns. A pilot version was administered to a series of ICD patients and repeated for test-retest reliability 6 weeks later. Psychometric tests including the screen test, factor analysis and various reliability assessments were undertaken. It was predicted that the greater the extent and severity of concerns, the greater the anxiety experienced by the ICD patient. Scores were compared with a validated measure of anxiety and depression administered at the same time. RESULTS: Fifty-seven (64%) patients completed and returned the questionnaire and a further 22 (100% of those asked) completed the 6-week retest. Reliability and validity appeared to be good and two factors were identified. Both total score and the individual factor scores correlated moderately with anxiety. CONCLUSIONS: The questionnaire appears to reflect patients' concerns and, as predicted, these were associated with the patients' anxiety level. The scale requires further testing to reveal if it is of use both clinically and for research purposes.

Cognitive-behavioural rehabilitation programme for patients with an implanted cardioverter defibrillator: a pilot study.

OBJECTIVES: The effectiveness of a comprehensive 12-week CR programme for ICD patients was evaluated. DESIGN: All surviving and suitable ICD patients being cared for by a regional implantation centre were invited to attend a 12-week cognitive-behavioural cardiac rehabilitation programme that had been modified to meet the needs of this group. Patients assenting were randomized to either an immediate treatment or a waiting treatment group. Measures were taken prior to randomization, at the end of the treatment or waiting period, at the end of the second treatment group for that group only and at three months post-treatment for both groups. OUTCOME MEASURES: The Hospital Anxiety and Depression Scale, the Total Concerns Questionnaire, the Quality of Life after Myocardial Infarction Questionnaire, the EuroQual (subjective health rating scale), the Shuttle Test and a number of ICD shocks and ATP episodes were used in this study. RESULTS: For those patients willing and able to attend, the cognitive-behavioural CR programme produced significant benefits in terms of psychological and functional adaptation to living with the device. CONCLUSIONS: A comprehensive 12-week CR programme that incorporated both psychological and exercise-based components significantly reduced anxiety and depression and improved quality of life of ICD patients. It is not clear if these benefits are sustained.