Abstract
BackgroundChronic diseases, including diabetes mellitus, are the leading cause of mortality and disability in the United States. Current solutions focus primarily on diagnosis and pharmacological treatment, yet there is increasing evidence that patient-centered models of care are more successful in improving and addressing chronic disease outcomes.ObjectiveThe objective of this clinical trial is to evaluate the impact of a mobile health (mHealth) enabled nurse health coaching intervention on self-efficacy among adults with type-2 diabetes mellitus.MethodsA randomized controlled trial was conducted at an academic health system in Northern California. A total of 300 participants with type-2 diabetes were scheduled to be enrolled through three primary care clinics. Participants were randomized to either usual care or intervention. All participants received training on use of the health system patient portal. Participants in the intervention arm received six scheduled health-coaching telephone calls with a registered nurse and were provided with an activity tracker and mobile application that integrated data into the electronic health record (EHR) to track their daily activity and health behavior decisions. All participants completed a baseline survey and follow-up surveys at 3 and 9 months. Primary and secondary outcomes include diabetes self-efficacy, hemoglobin A1c (HbA1c), and quality of life measures.ResultsData collection for this trial, funded by the Patient-Centered Outcomes Research Institute, will be completed by December 2017. Results from the trial will be available mid-2018.ConclusionsThis protocol details a patient-centered intervention using nurse health coaching, mHealth technologies, and integration of patient-generated data into the EHR. The aim of the intervention is to enhance self-efficacy and health outcomes by providing participants with a mechanism to track daily activity by offering coaching support to set reasonable and attainable health goals, and by creating a complete feedback loop by bringing patient-generated data into the EHR.Trial RegistrationClinicalTrials.gov NCT02672176; https://clinicaltrials.gov/ct2/show/NCT02672176 (Archived by WebCite at http://www.webcitation.org/6xEQXe1M5)
Highlights
Diabetes mellitus is a global epidemic highly amenable to health promotion interventions
Participants in the intervention arm received six scheduled healthcoaching telephone calls with a registered nurse and were provided with an activity tracker and mobile application that integrated data into the electronic health record (EHR) to track their daily activity and health behavior decisions
In collaboration with persons living with diabetes, healthcare providers, and technology stakeholders, we created a patient-centered intervention with the following components: 1) A wearable mobile activity tracker and nutrition apps; 2) Nurse health coaching sessions; and 3) Integration of patient-generated daily activity data into the EHR
Summary
A randomized controlled trial was conducted at an academic health system in Northern California. A total of 300 participants with type-2 diabetes were scheduled to be enrolled through three primary care clinics. Participants were randomized to either usual care or intervention. All participants received training on use of the health system patient portal. Participants in the intervention arm received six scheduled healthcoaching telephone calls with a registered nurse and were provided with an activity tracker and mobile application that integrated data into the electronic health record (EHR) to track their daily activity and health behavior decisions. All participants completed a baseline survey and follow-up surveys at 3 and 9 months. Primary and secondary outcomes include diabetes self-efficacy, hemoglobin A1c (HbA1c), and quality of life measures
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