CONSORT-EHEALTH Checklist V1.6.2 Report

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1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT The paper does not explicitly mention subitem 1b-i. However, the design and development of the webservice and/or email/SMS service was based on the behavioural theory of Prochaska and DiClemente. In this model the feedback to the patient is tailored based on the patient's phase of behavioural change. 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Subitem 1b-ii was addressed in the abstract as follows: "Based on registered activity data, they received semi-automatic telecoaching via e-mail and SMS, encouraging them to gradually achieve predefined exercise training goals. " 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Subitem 1b-iii was addressed in the abstract as follows: "The primary endpoint was peak aerobic capacity (VO2peak). Secondary endpoints included accelerometer recorded daily step counts, self-assessed physical activities by IPAQ and quality of life (QoL), assessed by the HeartQol questionnaire at baseline, 6 weeks and 24 weeks study period." 1b-iv) RESULTS section in abstract must contain use data Subitem 1b-iv is addressed in the abstract as follows: "Mean VO2peak increased significantly in IG patients (n = 69) from baseline [22.46 ± 0.78 ml/kg/min] to 24 weeks [24.46 ± 1.00ml/kg/min] (p < 0.001), contrary to CG patients (n = 70) where it did not change significantly (from 22.72 ± 0.74 ml/kg/min to 22.15 ± 0.77 ml/kg/min, p = 0.089). At 24 weeks, self-reported physical activity (MET-min/week) improved more in the IG, when compared to the CG (p = 0.001), as did the global QoL score (p = 0.005)." 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials The abstract of the artcile has a conclusion, namely: "This paper showed the addition of cardiac telerehabilitation to conventional center-based CR to be more effective than center-based CR alone in increasing aerobic capacity, physical activity level and associated QoL. These results are supportive in view of possible future implementation in standard cardiac care." The trial was not negative. INTRODUCTION 2a-i) Problem and the type of system/solution The problem is stated in the article as follows: ". After an acute cardiovascular event, the European Society of Cardiology (ESC) guidelines recommend cardiac rehabilitation (CR) to prevent recurrent disease for both coronary artery disease (CAD)2 and chronic heart failure (CHF)3 patients (Class IB). The long-term benefits of conventional center-based CR are often disappointing however, due to lack of adherence to prescribed life style behavior4. It is therefore important to examine and introduce adjunct intervention strategies to stimulate adherence to a healthy lifestyle. During the last decade, cardiac telerehabilitation was introduced as an adjunct or alternative to conventional CR in order to increase uptake rates, to enable more prolonged care and to improve long-term success. " The intended particular patient population is a cardiac patient population (coronary artery disease and heart failure patients). The goal of the intervention (in addition to the standard cardiac rehabilitation program) is to be more (cost-)effective than standard cardiac rehabilitation alone. 2a-ii) Scientific background, rationale: What is known about the (type of) system What is known about telerehabilitation for cardiac patients? This is stated in the article as: "Two systematic reviews on cardiac tele-interventions were published recently5,6 . Frederix et al. reported on cardiac telerehabilitation in CAD and CHF patients with a total of 13,248 patients enrolled in 37 studies; and a mean follow-up period of 9 months. They concluded that telerehabilitation was associated with significantly higher adherence rates to physical activity guidelines (Odds Ratio (OR) = 0.56, 95 % CI: 0.45-0.69)15-23. Huang et al. however, found no statistically significant difference between telehealth interventions and center-based CR for exercise capacity (standardized mean difference (SMD) = −0.01; 95 % CI: −0.12-0.10), quality of life and psychosocial state. The difference between these results and our findings could be attributed to differences in IG programs." So there is evidence on the effectiveness of cardiac telerehabilitation. Contrary to prior studies however, Telerehab III is comprehensive (it includes both telemonitoring and telecoaching) and it focuses on multiple core components of cardiac rehabilitation (physical activity, diet, smoking cessation). It is logical to compare the new intervention (telerehabilitation) to the current gold standard (standard cardiac rehabilitation i.e. the comparator). METHODS 3a) CONSORT: Description of trial design (such as parallel, factorial) including allocation ratio

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تاریخ انتشار 2015