CONSORT-EHEALTH Checklist V1.6.2 Report

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT "a structured telephone-based health coaching programme which was supported by a remote monitoring system! 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT "structured telephone-based health coaching" 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT "Patients were recruited by sending invitation to randomly selected patients using electronic health records. " "The primary outcome was the self-assessed health-related quality of life measured by SF 36 and the change of HbA1c among diabetic patients. The clinical measures assessed were blood pressure, weight, waist circumference, and lipid levels. " 1b-iv) RESULTS section in abstract must contain use data "267 heart patients and 250 diabetes patients started in the trial, of which 246 and 225 patients concluded the end point assessments, respectively". " The withdrawal was associated with the patients’ unfamiliarity with mobile phones: of the 41 dropouts, 84.6% (heart disease patients ) and 87.5% (diabetes patients) were familiar with mobile phones whereas the corresponding percentages were 97.1% and 98.6%, respectively, among the rest of the patients (P=0.019 and P=0.004). Withdrawal was also associated with heart disease patients’ comorbidities: 40% of the dropouts had at least one comorbidity whereas the corresponding percentage was 19% among the rest of the patients (P=0.038). " "The intervention showed no statistically significant benefits over the current practice with regard to the quality of life (heart disease patients: β=0.730, P=0.358 for physical component score and β=-0.608, P=0.616 for mental component score, diabetes patients: β=0.875, P=0.853 for physical component score, β=-0.770, P=0.523 for mental component score) or Hba1c (diabetes patients: β=-0.106, P=0.336). " 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials Health coaching programme supported with telemonitoring did not improve heart disease patients' or diabetes patients’ quality of life or their clinical condition. INTRODUCTION 2a-i) Problem and the type of system/solution "There is a strong will and need to find alternative models of health care delivery [1] driven by the ever-increasing burden of chronic diseases. To ensure adequate resources for the delivery of health care and to further improve the level of care, care-delivery models need to be changed in a way that patients themselves become more involved of their own care. " "Home telemonitoring of chronic diseases seems to be a promising disease management approach with potential to boost patients’ compliance with selfcare while bringing health care services closer to patients. " "For successful disease management, the education of a patient is important. However, the education-based interventions are by themselves insufficient [10]. Health coaching helps the patient to clarify his motivation to initiate and maintain change, offering a variety of perspectives and recognizing that numerous factors contribute to achieving goals [11]. " 2a-ii) Scientific background, rationale: What is known about the (type of) system "The evidence on the effectiveness of telemonitong is contradictive and is dependent on the nature of the disease [2]. In a systematic review by Pare et al.[2] it was found that telemonitoring improved glycaemic control of diabetics, decreased blood pressure levels of hypertensive patients and improved peak expiratory flows of patients with asthma and symptoms associated with the illness. However, the beneficial effect of telemonitoring was not associated with heart failure and the evidence is still contradictive. " "Promising results have been obtained among type 2 diabetes patients in health coaching conducted by telephone [11]. However, the one-year lasting TERVA trial, in which health coaching approach was applied, failed to achieve the most of the expected improvements in clinical measures [12]. " METHODS 3a) CONSORT: Description of trial design (such as parallel, factorial) including allocation ratio The purpose of this study was to examine whether a structured telephone-based health coaching program, which is supported by a remote monitoring system, could be used to improve the quality of life and/or the clinical measures of type 2 diabetes and heart disease patients. We hypothesized to see an improvement in patients’ quality of life. 3b) CONSORT: Important changes to methods after trial commencement (such as eligibility criteria), with reasons No changes. 3b-i) Bug fixes, Downtimes, Content Changes "The system underwent no major changes or updates during the trial. " 4a) CONSORT: Eligibility criteria for participants "The diabetic patients were recruited based on the diagnosis of Diabetes Mellitus type 2 and their glycated haemoglobin (HbAc1) level that was measured to be over 6.5% within one year prior to the screening. It was required that the diabetes had been diagnosed at least 3 months earlier. The heart disease group included patients with diagnosed ischemic heart disease or heart failure or both. Other inclusion criteria were: 18 years of age or older, ability to fill in questionnaires in Finnish, ability to use the RPM system and the devices provided, having adequate cognitive capacities to participate, and being able to walk. " 4a-i) Computer / Internet literacy Inclusion criteria: ability to fill in questionnaires in Finnish, ability to use the RPM system and the devices provided. 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: