Patient Activation Program + Text Messaging for Type 2 Diabetes
Trial Summary
What is the purpose of this trial?
Cardiovascular disease (CVD) complications are the leading cause of diabetes mellitus (DM)-related morbidity and mortality, creating a significant burden on the public health system. This burden is, in part, attributable to poor medication adherence, with 21-42% of patients failing to properly adhere to their care. Importantly, this issue is especially pronounced in minority and low-income populations, which show higher rates of chronic illness and lower medication adherence. Interventions that foster and reinforce patient-centered communication between clinicians and patients show promise in improving health outcomes. However, they have not been widely implemented, in part due to a lack of compelling evidence for their effectiveness in primary care settings. Project Objective: The investigators propose to evaluate the impact of a patient activation program: Office Guidelines Applied to Practice (Office-GAP) combined with mobile text messaging reinforcement (Way to Health \[W2H\]) on medication adherence in patients with DM compared to mobile texting alone. Office-GAP incorporates shared decision-making and a decision/support checklist to be completed during office visits, to foster patients' investment in their own care. W2H is a texting service that informs and encourages patients to adhere to goals and improve communication. The long-term goal is to develop a model that can reliably improve and sustain adherence and can be successfully implemented in primary care clinics to close the morbidity and mortality gap for minority/low-income DM patients. The hypothesis is that the combined face-to-face patient activation and texting- delivered reinforcement methods will facilitate communication between patients and providers, improving the frequency, accuracy, and timeliness of communication while reinforcing shared goals and engendering mutual respect more than texting alone. Improved communication between patients and providers may improve medication adherence, blood sugar, cholesterol, blood pressure control, and patient satisfaction with providers, and ultimately decrease burden of illness. Research Strategy: The investigators will conduct a randomized community-based clinical trial in Federally-Qualified Health Centers (FQHCs) in Michigan enrolling 378 patients in 17 teams. All patients will receive usual care and medication for DM and CVD prevention. Eight teams will use W2H alone, and 9 teams will combine Office-GAP with WTH. The investigators will evaluate the impact of shared decision-making strategies for patients and providers. Impact: If successfully translated to clinical practice, these interventions have the potential to significantly impact patient care in FQHCs, improving outcomes for DM and CVD. This research also paves the way for shifting clinical practice across a spectrum of chronic disease where medication non-adherence is an issue.
Will I have to stop taking my current medications?
The trial does not specify that you need to stop taking your current medications. In fact, all patients will continue to receive their usual care and medication for diabetes and cardiovascular disease prevention.
What data supports the effectiveness of the treatment Mobile text messaging, Office Guidelines Applied to Practice (Office-GAP) + Mobile text messaging, Office-GAP + W2H, Office Guidelines Applied to Practice + Mobile Text Messaging for Type 2 Diabetes?
Research shows that text messaging can help people with type 2 diabetes manage their condition by providing reminders and motivation for self-care activities, like physical activity and healthy eating. While the exact combination of treatments in the trial hasn't been directly studied, similar text messaging programs have been found to improve health outcomes and patient satisfaction.12345
Is text messaging for diabetes management safe for humans?
How is the Patient Activation Program + Text Messaging treatment for Type 2 Diabetes different from other treatments?
Research Team
Adesuwa Olomu, MD, MS
Principal Investigator
Michigan State University
Eligibility Criteria
This trial is for adults over 18 with Type 2 diabetes and HbA1c >8, who are taking medication for blood pressure or cholesterol. They must be able to consent, have a cell phone (provided if needed), and read/speak English at a grade 6 level. It excludes those planning to move away, with cognitive impairments or in another cellphone program.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive either Office-GAP + mobile phone text messaging or mobile phone text messaging alone
Follow-up
Participants are monitored for medication adherence and health outcomes
Treatment Details
Interventions
- Mobile text messaging (Behavioral Intervention)
- Office Guidelines Applied to Practice (Office-GAP) + Mobile text messaging (Behavioral Intervention)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Michigan State University
Lead Sponsor
Doug Gage
Michigan State University
Chief Executive Officer
PhD in Botany from the University of Texas
David Smith
Michigan State University
Chief Medical Officer
MD from Michigan State University
University of Michigan
Collaborator
Marschall S. Runge
University of Michigan
Chief Executive Officer since 2015
MD, PhD
Karen McConnell
University of Michigan
Chief Medical Officer since 2020
MD