Decreasing Cardiovascular Risk for Patients With Diabetes
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.
Conditions:
🦠 Diabetes Mellitus, Type 2
🗓️ Study Start (Actual) 26 May 2021
🗓️ Primary Completion (Estimated) April 2025
✅ Study Completion (Estimated) April 2025
👥 Enrollment (Estimated) 378
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Lansing, Michigan, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • Patients: aged \>18 at participating Federally Qualified Health Care centers (FQHCs) and; 1) have a diagnosis of Type 2 diabetes (T2DM) with HbA1c \>8, with or without CVD; 2) patient should be taking at least one prescribed medication for BP or cholesterol management 3) able to provide informed consent 4) able to read and speak English (grade 6 reading level); 5) have a cell phone with texting (provided by our study for any enrolled patient who does not have one).

    Exclusion Criteria:

    • 1) medical record documentation of cognitive impairment, dementia or psychosis 2) plans to leave the area prior to study completion 3) participating in another cellphone program.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 1 March 2021
  • First Submitted that Met QC Criteria 1 May 2021
  • First Posted 5 May 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 24 August 2022
  • Last Update Posted 25 August 2022
  • Last Verified August 2022