Measuring the Effects of Sharing Mobile Health Data During Diabetes Consultations: Protocol for a Mixed Method Study

Abstract

Background There is rising demand for health care’s limited resources. Mobile health (mHealth) could be a solution, especially for those with chronic illnesses such as diabetes. mHealth can increases patients’ options to self-manage their health, improving their health knowledge, engagement, and capacity to contribute to their own care decisions. However, there are few solutions for sharing and presenting patients’ mHealth data with health care providers (HCPs) in a mutually understandable way, which limits the potential of shared decision making. Objective Through a six-month mixed method feasibility study in Norway, we aim to explore the impacts that a system for sharing patient-gathered data from mHealth devices has on patients and HCPs during diabetes consultations. Methods Patients with diabetes will be recruited through their HCPs. Participants will use the Diabetes Diary mobile phone app to register and review diabetes self-management data and share these data during diabetes consultations using the FullFlow data-sharing system. The primary outcome is the feasibility of the system, which includes HCP impressions and expectations (prestudy survey), usability (System Usability Scale), functionalities used and data shared during consultations, and study-end focus group meetings. Secondary outcomes include a change in the therapeutic relationship, patient empowerment and wellness, health parameters (HbA1c and blood pressure), and the patients’ own app-registered health measures (blood glucose, medication, physical activity, diet, and weight). We will compare measures taken at baseline and at six months, as well as data continuously gathered from the app. Analysis will aim to explain which measures have changed and how and why they have changed during the intervention. Results The Full Flow project is funded for 2016 to 2020 by the Research Council of Norway (number 247974/O70). We approached 14 general practitioner clinics (expecting to recruit 1-2 general practitioners per clinic) and two hospitals (expecting to recruit 2-3 nurses per hospital). By recruiting through the HCPs, we expect to recruit 74 patients with type 2 and 33 patients with type 1 diabetes. Between November 2018 and July 2019, we recruited eight patients and 15 HCPs. During 2020, we aim to analyze and publish the results of the collected data from our patient and HCP participants. Conclusions We expect to better understand what is needed to be able to share data. This includes potential benefits that sharing patient-gathered data during consultations will have on patients and HCPs, both individually and together. By measuring these impacts, we will be able to present the possibilities and challenges related to a system for sharing mHealth data for future interventions and practice. Results will also demonstrate what needs to be done to make this collaboration between HCPs and patients successful and subsequently further improve patients’ health and engagement in their care.

Exploring Real-World mHealth Use for Diabetes Consultations: Pros and Pitfalls of a Pragmatic Mixed-Methods Approach

“…No incentives were offered besides compensating study-end focus group meeting participants for their time taken off of work and travel costs. More details are provided in the published protocol article [6]. To assess the quality of our study design's and administration's adherence to the definition of pragmatic studies-"to evaluate the effectiveness of interventions in real-life routine practice conditions" [7]-the research team used a tool developed by Loudon et al, PRECIS-2 [8].…”

Mobile Health in Chronic Disease Management and Patient Empowerment: Exploratory Qualitative Investigation Into Patient-Physician Consultations

“…This, in turn, supports patients in self-managing their health and coping with diseases [2]. Furthermore, mHealth enables information sharing between patients and health care professionals [19]. As a result, patients increase their knowledge, which helps them to self-manage chronic diseases [19,23].…”

“…During patient-physician consultations, PRO data support physicians in evaluating the health status of patients. However, despite studies of how PRO data and mHealth support patient empowerment [17][18][19], there is a scarcity of research on how mHealth and other technologies are used during patient-physician consultations, and extant studies often ignore the fact that empowerment depends on the patient-physician relationship [8,20]. Consequently, there is limited knowledge of how and to what extent the use of mHealth during consultations affects empowerment.…”

“…Furthermore, mHealth enables information sharing between patients and health care professionals [ 19 ]. As a result, patients increase their knowledge, which helps them to self-manage chronic diseases [ 19 , 23 ]. However, studies have reported problems such as constantly reminding patients that they are chronically ill [ 30 ].…”

Use of Wearable Device among Adults in the US with Self-reported Diabetes Mellitus: An Analysis of the 2019 Health Information National Trends Survey

“…[14] Wearable technology is increasingly being utilized to care for individuals with chronic diseases especially with increasing demand from limited healthcare resources. [15,16,17] These tools have shown promise in several chronic health conditions, such as obesity, hypertension, cancer, heart disease and more. [18] Non-prescription wearable activity trackers also referred to as "wearable devices" in this study includes Fitbit, Apple watch, Garmin Vivofit, etc.…”