Cardiac Rehabilitation Program using Telemonitoring; The effects of an extended program with Telemonitoring guidance versus standard follow-up in patients after Cardiac Rehabilitation

Study which investigates whether an extended cardiac rehabilitation program with telemonitoring guidance results in a better long term effect on physical and mental outcomes than a regular follow-up period after traditional cardiac rehabilitation. The design used for this study is an open prospective, investigator initiated randomized clinical trial. A total of 120 cardiac patients who almost completed cardiac rehabilitation (after approval cardiologist), will be included in this interventional study and randomly assigned by an algorithm to one of the 2 study groups, i.e. the 6 months telemonitoring follow-up program, or 6 months of regular follow-up after cardiac rehabilitation. Both groups have an additional 6 months of follow-up after the first period without any intervention. Measurements in both groups will be performed at baseline, and after 6, and 12 months during the program

Extension of the cardiac rehabilitation program with telemonitoring guidance results in better long term effects on physical and mental outcomes than a regular follow-up period after traditional cardiac rehabilitation.

Testing will be performed at baseline, at 6 and 12 months

The intervention of the study starts when patients finish their initial cardiac rehabilitation program. Patients participating in the extended cardiac rehabilitation program with telemonitoring will undergo 6 months of telemonitoring guidance and in addition another 6 months without telemonitoring. The telemonitoring group will receive instructions before they start training with a heart rate monitor in their home environment. Patients are instructed to perform a moderate exercise 5 days per week for at least half an hour. The duration and intensity (based on the heart rate data) of each training/activity is collected by the smartphone and transferred to a secured website where both patient and researchers/nurses involved in the study can view the results. During the first month patients receive weekly individual coaching and feedback on their results by telephone, in the second month this will be once per two weeks, whereas one monthly call will be held in the last four months (month 3 until 6) of the telemonitoring period. The telephone calls will be performed by a physician or nurse specialized in cardiac rehabilitation. In the second period without telemonitoring (month 7 until 12) patients will receive no coaching or feedback by phone. Subjects participating in the control group will undergo 6 months of regular follow-up after initial cardiac rehabilitation with another 6 months in addition. After the first 6 months patients in the control group have a group meeting held by a nurse specialised in cardiac rehabilitation. During this meeting patients will talk and reflect with one another and receive feedback on their individual Performance of the maximal incremental cycle test and lab results of cardiovascular risk factors. Besides the group meeting, patients in the control group receive no other coaching or feedback during these 12 months.