Journal of Clinical Trials
Open Access

Abstract

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

John D Piette, Ananda Sen and James E Aikens

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.