Ann-Dorthe Zwisler

COPE-ICD: A randomised clinical trial studying the effects and meaning of a comprehensive rehabilitation programme for ICD recipients -design, intervention and population

BackgroundGrowing evidence exists that living with an ICD can lead to fear and avoidance behaviour including the avoidance of physical activity. It has been suggested that psychological stress can increase the risk of shock and predict death. Small studies have indicated a beneficial effect arising from exercise training and psychological intervention, therefore a large-scale rehabilitation programme was set up.Methods/DesignA mixed methods embedded experimental design was chosen to include both quantitative and qualitative measures. A randomised clinical trial is its primary component. 196 patients (power-calculated) were block randomised to either a control group or intervention group at a single centre. The intervention consists of a 1-year psycho-educational component provided by two nurses and a 12-week exercise training component provided by two physiotherapists. Our hypothesis is that the COPE-ICD programme will reduce avoidance behaviour, sexual dysfunction and increase quality of life, increase physical capability, reduce the number of treatment-demanding arrhythmias, reduce mortality and acute re-hospitalisation, reduce sickness leading to absence from work and be cost-effective. A blinded investigator will perform all physical tests and data collection.DiscussionMost participants are men (79%) with a mean age of 58 (range 20-85). Most ICD implantations are on primary prophylactic indication (66%). 44% is NYHA II. Mean walk capacity (6MWT) is 417 m. Mean perception of General Health (SF-36) is PCS 42.6 and MCS 47.1.A large-scale ICD rehabilitation trial including psycho-educational intervention and exercise training has been initiated and will report findings starting in 2011.Trial RegistrationClinicalTrials.gov: NCT00569478

COPE-ICD: patient experience of participation in an ICD specific rehabilitation programme.

Purpose: Evaluating rehabilitation programmes from the patient’s perspective is much needed, as the patients are the most important stakeholders in the health care system. A comprehensive rehabilitation programme, COPE-ICD programme, consists of exercise training and nursing consultations during a one year period post ICD implantation. The purpose of this paper is to describe the experience and meaning of participating in a comprehensive ICD-specific rehabilitation programme. Methods: Qualitative interviews were conducted with 10 patients representing the participating population, and later transcribed. The analysis was inspired by Ricoeur’s theory of interpretation, which consists of three levels: naive reading, structured analysis and critical interpretation and discussion. Results: The overall concept was that participating in the COPE-ICD programme meant feeling inspired and secure through individualized care. Four themes emerged: Knowledge: patients gained much needed understanding; Physical attention: patients interpreted body signals and adjusted their exercise behaviour; Trust: patients regained trust, felt secure and dared to live again; Strategies of living: patients’ coping was supported through reflection and professional dialogue, and they dealt with the risk of shock or death. Conclusion: Participating in an ICD-specific rehabilitation programme can make patients feel inspired and secure through individualized care. They discover that they have to rethink some of their strategies of living and they gain support in the reflection and coping needed for that. Patients gain insight and they develop a special physical attention whereby they continue healthy activities through interpreting body signals and adjusting exercise behaviour. They learn to trust their body again.

Sexual concerns and practices after ICD implantation: findings of the COPE-ICD rehabilitation trial

Background: Studies show that patients with implantable cardioverter defibrillators (ICD) frequently experience sexual dysfunction. These experiences are often linked to exercise intolerance, side-effects of medication, and psychological problems. Objective: To describe (a) the level of information given about sexual activity, (b) the areas of patient concerns related to sexual function and the ICD, and (c) changes in sexual behavior. Methods: A randomized controlled trial including 196 patients (1:1) was designed, including 12 weeks of exercise training and 1 year of psycho-educational follow-up focusing on modifiable factors associated with poor outcomes, including sexual functioning. The Sex After ICD Survey was administered 6 months after the randomization as part of the planned explorative outcomes. 141 patients responded. Results: The analyses showed that 37 of the 69 (55.2%) patients of the intervention group and 16 of the 72 (24.6%) patients of the control group received information (p<0.001). The areas of greatest concern reported by many patients were: lack of interest in sex, erectile dysfunction, and an over-protective partner. Fewer patients were sexually active 6 months after the ICD implantation than before the ICD implant: 51.8% versus 66.7%. In the intervention group, patients had sexual intercourse a mean of 4.9 times during the previous 2 months versus 4.0 in the control group (p=0.4). Conclusion: Despite having received more information, no interventional effect was found between groups in terms of sexual concerns or activity.

Sick leave after first time ICD implantation: results from a randomized controlled rehabilitation trial

Background: Heart failure is a common chronic condition that affects patients’ life situation and puts high demands on self-care and patient participation. Patients often need advanced care due to ...

Return to work after first time ICD implantation: results from a randomized controlled rehabilitation trial

Background: Heart failure is a common chronic condition that affects patients’ life situation and puts high demands on self-care and patient participation. Patients often need advanced care due to ...