Telehealth Pharmacist Intervention for Type 2 Diabetes

Overseen By McKenzie Isreal, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Gestational diabetes, Type 1 diabetes, Serious mental illnesses, Malignant cancer, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

87 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of the project is to inform the system leaders regarding the feasibility and utility of having an embedded telehealth-based clinical pharmacist at rural primary care practices for supportive disease management of patients with Type 2 diabetes (T2D) and whether continuing and expanding the program within the system is worthwhile.

Who Is on the Research Team?

Rohan Mahabaleshwarkar, PhD

Principal Investigator

Atrium Health Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 75 living in rural areas with uncontrolled Type 2 diabetes, as shown by their health records. Participants must have a recent HbA1c level of at least 8%. People with cancer, other chronic disease programs, specialist T2D care, or serious mental illnesses are excluded.

Inclusion Criteria

HbA1c reading ≥ 8% recorded during 6 months prior to or up to 9 days after the encounter at the participating practices

My type 2 diabetes has been uncontrolled in the past year.

Exclusion Criteria

Those with serious mental illnesses (schizophrenia and other psychotic disorders, major depressive disorders, bipolar disorders, and borderline personality disorder)

I have either gestational or type 1 diabetes.

Those enrolled in any other chronic disease management programs delivered by non-physician healthcare professionals

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a telehealth-based clinical pharmacy intervention for diabetes management, including biweekly video/phone calls with a pharmacist for 3 months

12 weeks

6 visits (virtual)

Follow-up

Participants are monitored for changes in blood pressure, HbA1c, and medication adherence from baseline to follow-up

17 months

What Are the Treatments Tested in This Trial?

Interventions

• Telehealth-based Clinical Pharmacy Intervention

Trial Overview The study tests if having a pharmacist provide telehealth support for diabetes management in rural primary care helps control Type 2 diabetes better and if it's worth expanding this service within the healthcare system.

How Is the Trial Designed?

Group I: telehealth-based clinical pharmacy intervention Experimental Treatment 1 Intervention

will involve a pharmacist identifying and addressing medication-related problems (e.g., inappropriate dosage or indications, drug interactions, and therapeutic duplication); optimizing medication regimens (discontinuing if appropriate, providing subsidized and generic options, and reducing medication complexity); and providing T2D education and self-management support

Group II: usual care Active Control 1 Intervention

will involve routine physician office visits every 3 (for those with HbA1c outside goal) - or every 6 months (for those with HbA1c within goal). Medication regimens are usually managed by physicians, nurse practitioners, and physician assistants, and Patients have access to centralized chronic disease management programs.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+