This trial will compare two methods of increasing engagement in care and success in diabetes management, among patients with diabetes with high-risk features, who also have family members involved in their care.
Who can participate
Age range
30 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patient Inclusion Criteria:
* Provide signed and dated informed consent form
* Plan to be be available for the duration of the study
* Male or female, age 30-70 years old
* Plan to get most diabetes care at recruiting VA primary care clinic over the subsequent 12 months
* Able to use telephone to respond to bi-weekly automated Interactive Voice Response (IVR) calls
* Be able to identify an adult family member or friend who is regularly involved in their health management or health care (involved with medications, managing sugars, coming to appointments, etc)
* Have a diagnosis of diabetes and be at high-risk for diabetes complications, defined as: (1) a diagnosis of diabetes based on encounter diagnoses from 1 inpatient or 2 outpatient encounters (OR a diabetes medication (at least one \>3 month prescription from VA drug classes HS501 (insulin) or HS502, other than metformin), (2) have an assigned VAprimary care provider and at least 2 visits to VA primary care in the previous 12 months, (3) poor glycemic control (last HbA1C within 9 months \>8%) OR poor blood pressure control (last BP 160/100 or mean 6 month BP \>150/90)
Care Partner Inclusion Criteria:
* 21 years old or older
* Fluent in English
* Live in the United States
Exclusion Criteria:
Patient Exclusion Criteria:
* Expect to have \>1 month gap in VA care in the 12 months following enrollment (e.g. snowbird travel).
* Plan to receive the majority of their care for diabetes mainly from a non-…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Patient Activation, as Measured by Patient Activation Measure - 13
Timeframe: Baseline to 12 months
2
Change in Cardiac Event 5-year Risk Score, as Measured by UKPDS Risk Engine