Randomized Controlled Trial of mHealth Telemonitoring with Enhanced Caregiver Support for Diabetes Self-management

John D Piette Ananda Sen

doi:10.4172/2167-0870.1000194

Abstract

Objective: To determine the benefits of a mobile health (mHealth) telemonitoring and self-management support program for diabetes that includes feedback to a patient-selected support person. Methods: Participants are patients with poorly controlled type 2 diabetes (HbA1c ≥ 7.5%) who nominate a close friend or adult relative from outside their home (“CarePartner;” CP) who is willing to support their diabetes selfmanagement. Patients are then randomized to receive one year of usual care alone or the mHealth+CP program. In the program arm: (a) patients receive weekly automated diabetes telemonitoring calls that include self-management guidance, (b) their CPs receive emailed updates on the patient’s diabetes that include guidance on supporting their self-management, and (c) their primary care teams receive faxed notifications about medically urgent issues that they report. Assessments are being performed at Baseline, Month 6, and Month 12. The primary outcomes are 12- month glycemic control and diabetes distress, and we are also exploring secondary effects upon diabetes selfmanagement behaviors, health-related quality of life, systolic blood pressure, and relationship quality. Conclusion: To our knowledge, this is the only mHealth intervention for any condition that involves a patientsselected support person. If it proves effective, then a new, low-cost, sustainable intervention would be available to improve diabetes outcomes, especially for patient who are medically underserved or socially isolated.

Highlights

Inadequate self-management of blood glucose and blood pressure among patients with type 2 diabetes are prospectively associated with chronic hyperglycemia, microvascular complications, and heart disease [1]
Mobile health services, including interactive voice response (IVR) calls in which patients respond to automated prompts, may help address these barriers to effective care management [4,5]
While some patients have a geographically-distant support person, these caregivers usually receive infrequent and insufficiently-detailed updates about the patient’s diabetes health status [9]. In response to these problems, we developed the Mobile health (mHealth) system to automatically provide weekly telemonitoring of diabetes patients

Summary

Methods

Eligibility and recruitment In order to participate, patients must: have type 2 DM (hospitalization or outpatient visit within 12 months for >2 ICD9 codes of 250.XX or therapeutic class codes C4G, C4K, or C4L in past 2 years’ problem list), and be in poor glycemic control as indicated by a recent HbA1c% >7.5% They were required to be ≥ 21 years of age; fluent in English, able to use a telephone touchpad; and able to identify an eligible CP. We measure general physical and mental functioning with the Medical Outcome Study 12-Item Short Form (SF-12) [16], which is reliable and has been validated for use with diabetes patients [17]. Ancillary data sources We measure outpatient services, hospitalizations, and medication use from site-specific administrative databases and patient self-report over six-month periods, from which we can estimate costs. We will use the same approach to evaluate whether mHealth+CP improves the secondary outcomes of diabetes self-management, health-related quality of life, systolic blood pressure, and caregiver relationships

Conclusion

Introduction

Results

Discussion

Conflicts of Interest