Decreasing Cardiovascular Risk for Patients With Diabetes

NCT04874116 | Active Not Recruiting DMC

• 1 other identifier: R01HL149777-01A1
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (3)

• Change in Medication adherence

  eCAP records real-time adherence data, tracking each opening with date and time

  Progression of adherence over 12 months

• Change in Medication adherence

  Adherence to Refills and Medication (ARMs).

  Progression of adherence over 12 months

• Change in Medication Adherence

  Survey to assess medication adherence

  Progression of adherence over 12 months

Secondary Outcomes (3)

• Change in UK Prospective Diabetes Study (UKPDS)

  Progression of risk over 12 months

• Change in Patient activation measure

  Progression of activation model over 12 months

• Change in CollaboRATE

  Progression of shared decision-making over 12 months

Study Arms (2)

Office Guidelines Applied to Practice (Office-GAP) + mobile phone text messaging

EXPERIMENTAL

Participants receive Office Guidelines Applied to Practice (Office-GAP) + mobile phone text messaging for 12 months.

Behavioral: Office Guidelines Applied to Practice (Office-GAP) + Mobile text messaging

Mobile phone text messaging

ACTIVE COMPARATOR

Participants receive mobile phone text messaging alone for 12 months.

Behavioral: Mobile text messaging

Interventions

Office Guidelines Applied to Practice (Office-GAP) + Mobile text messaging BEHAVIORAL

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. Way to Health is a cell phone messaging service that informs and encourages patients to adhere to goals and improve communication.

Office Guidelines Applied to Practice (Office-GAP) + mobile phone text messaging

Mobile text messaging BEHAVIORAL

Way to Health is a cell phone messaging service that informs and encourages patients to adhere to goals and improve communication.

Mobile phone text messaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Michigan State University: lead
• University of Michigan: collaborator

Study Sites (1)

Ingham Healthcare center

Lansing, Michigan, 48742, United States

Location

Related Publications (4)

• Olomu A, Hart-Davidson W, Luo Z, Kelly-Blake K, Holmes-Rovner M. Implementing shared decision making in federally qualified health centers, a quasi-experimental design study: the Office-Guidelines Applied to Practice (Office-GAP) program. BMC Health Serv Res. 2016 Aug 2;16(a):334. doi: 10.1186/s12913-016-1603-3.

  PMID: 27484348 BACKGROUND

• Olomu A, Khan NN, Todem D, Huang Q, Kumar E, Holmes-Rovner M. The Office Guidelines Applied to Practice program improves secondary prevention of heart disease in Federally Qualified Healthcare Centers. Prev Med Rep. 2016 Jun 29;4:357-63. doi: 10.1016/j.pmedr.2016.06.020. eCollection 2016 Dec.

  PMID: 27512651 BACKGROUND

• Olomu A, Khan NNS, Todem D, Huang Q, Bottu S, Qadri S, Holmes-Rovner M. Blood Pressure Control in Hypertensive Patients in Federally Qualified Health Centers: Impact of Shared Decision Making in the Office-GAP Program. MDM Policy Pract. 2016 Jul 7;1(1):2381468316656010. doi: 10.1177/2381468316656010. eCollection 2016 Jul-Dec.

  PMID: 30288401 BACKGROUND

• Olomu A, Kelly-Blake K, Hart-Davidson W, Gardiner J, Luo Z, Heisler M, Holmes-Rovner M. Improving diabetic patients' adherence to treatment and prevention of cardiovascular disease (Office Guidelines Applied to Practice-IMPACT Study)-a cluster randomized controlled effectiveness trial. Trials. 2022 Aug 15;23(1):659. doi: 10.1186/s13063-022-06581-6.

  PMID: 35971135 DERIVED

Related Links

• Reach, Effectiveness, Adoption, Implementation, Maintenance

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Adesuwa Olomu, MD, MS

  Michigan State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Swartz Endowed Professor of Medicine

Model Details: Office-GAP is a Patient Activation Intervention Program for Group 1 that includes: 1) Group visit 2) Provider training for patient activation, and 3) Office-GAP checklist used in the office. Patients in Groups 1 and 2 will attend one group visit and 5 follow-up visits with their provider in 1 month, 3, 6, 9 and 12 months after the group visit. For Group 1, the group visit is a shared decision making (SDM) activation session wherein patients learn self-management behaviors, medication use, communication skills, and use of decision support tools (DST). The Office-GAP Checklist is an in-consultation DST that helps engage the patient and provider in initiating and enhancing a SDM process via discussion of medication and secondary prevention/lifestyle changes. Way to Health is a text-based DM self-management program. Groups 1 and 2 receive a 15-week customized program of text messages after the group visit. For the remaining 12 months, they will receive standard diabetic education modules.

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: May 5, 2021
• Study Start: May 26, 2021
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publication of study findings in peer reviewed journals
• Access Criteria: Access it through the PI Dr. Ade Olomu

Locations

US (1)