Self-Management and Clinical Decision Support for Patients With Complex Chronic Conditions Through the Use of Smartphone-Based Telemonitoring: Randomized Controlled Trial Protocol

Background The rising prevalence of chronic illnesses hinders the sustainability of the health care system because of the high cost of frequent hospitalizations of patients with complex chronic conditions. Clinical trials have demonstrated that telemonitoring can improve health outcomes, but they have generally been limited to single conditions such as diabetes, hypertension, or heart failure. Few studies have examined the impact of telemonitoring on complex patients with multiple chronic conditions, although these patients may benefit the most from this technology. Objective The aim of this study is to investigate the impact of a smartphone-based telemonitoring system on the clinical care and health outcomes of complex patients across several chronic conditions. Methods A mixed-methods, 6-month randomized controlled trial (RCT) of a smartphone-based telemonitoring system is being conducted in specialty clinics. The study will include patients who have been diagnosed with one or more of any of the following conditions: heart failure, chronic obstructive pulmonary disease, chronic kidney disease, uncontrolled hypertension, or insulin-requiring diabetes. The primary outcome will be the health status of patients as measured with SF-36. Patients will be randomly assigned to either the control group receiving usual care (n=73) or the group using the smartphone-based telemonitoring system in addition to usual care (n=73). Results Participants are currently being recruited for the trial. Data collection is anticipated to be completed by the fall of 2018. Conclusions This RCT will be among the first trials to provide evidence of the impact of telemonitoring on costs and health outcomes of complex patients who may have multiple chronic conditions. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 41238563; http://www.isrctn.com/ISRCTN41238563 (Archived by WebCite at http://www.webcitation.org/6ug2Sk0af) and Clinicaltrials.gov NCT03127852; https://clinicaltrials.gov/ct2/show/NCT03127852 (Archived by WebCite at http://www.webcitation.org/6uvjNosBC)

We are pleased to inform you that the Canadian Institutes of Health Research (CIHR) has approved your recent application entitled "Self-management and clinical decision support of multiple chronic conditions through the use of mobile health telemonitoring". Since you are receiving this letter through ResearchNet your Authorization for Funding will follow in the mail. If you cannot access the review documents related to your proposal through ResearchNet, please contact the CIHR staff member listed below.
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Once again, I offer you my congratulations and best wishes for success in your research. 1. A brief synopsis of the proposal Medly will enable patients with MCCs to take physiological measurements with wireless home medical devices and to answer symptom questions on the mobile phone. The measurements will be automatically and wirelessly transmitted to the mobile phone and then to a data server. Specifically, patients with HF will monitor daily weight and blood pressure/heart rate, CKD patients will monitor blood pressure, and all patients (including COPD) will monitor symptoms. A small feasibility pilot will be conducted to validate the tool, revealing any issues in clinical workflow, telemonitoring system design, methods for patient recruitment, etc. prior to the proposed randomized controlled trial (RCT). The telemonitoring platform named "Medly", will be specifically evaluated for three chronic conditions: HF, COPD, and CKD. HF and COPD are among the most common causes for avoidable hospitalizations (31), and CKD patients incur very high costs when hemodialysis is required (32, 33).
o the hypothesis to be tested, or the questions to be answered; What is the impact of a telemonitoring system for patients with MCCs, on self-management, clinical outcomes and health service utilization? The study will include high-risk patients who account for the largest healthcare spending (i.e., high-risk for re-hospitalization; defined as having been hospitalized within the last 6 months).
o the objectives to be achieved and approach proposed; A RCT will be conducted to determine the impact of Medly on healthcare costs and clinical outcomes. The trial will be conducted at the HF, COPD, and CKD clinics at the University Health Network (UHN), Toronto, ON. Patients (n=134) with at least two of the chronic conditions will be recruited through the clinics and randomized.
The control group will receive usual care, and the intervention group will receive usual care plus the telemonitoring intervention. Both groups will be followed for 6 months. It is anticipated that 3 months will be required for trial preparation, 8 months starting January 2014 will be required for recruitment (based on 900 patients seen/year in the Heart Function Clinic, and over 600 patients seen/year in the CKD and COPD clinics, and approximately half of them with co-morbid conditions). About 1 month will be apportioned for data analysis and reporting o the progress made to date.
The researchers have assembled an incredible team of experts, a boat-load of additional funding to support various aspects of this project, and have developed and tested one of the chronic condition modules.
2. An assessment of the proposal, based on the evaluation criteria as presented in the funding opportunity consider all factors and the strengths or weaknesses of the applications in relation to each criteria; details: o this is a great research team, working in a great environment, on important topics.
While they are technically using information technology, the innovation in this project is not in the use of the technology itself (i.e., blood pressure and weight recording technologies are not new), but rather in how this will fit in with the patients lifestyle and the clinicians work flow. Unfortunately, they have not devoted many resources (other than a few interviews of patients and clinicians) to these aspects of the project. my reading of the literature on these types of projects seems to show that patients who use the technology seem to benefit from it, but only a small subset of patients are willing or able to make use of the devices. It seems to me that more research needs to be done to understand these issues or barriers. . For example, ethical issues, eligibility, If necessary, comments on issues the reviewer feels should be flagged compatibility with CIHR policies, etc. Such concerns, however, must not prevent a committee from evaluating