Outreach Methods for Type 2 Diabetes Screening

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Type 2 diabetes

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

Compensation: Varies

Number of Visits: Unknown

105 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Approximately 130 million Americans have prediabetes or type 2 diabetes (T2D) but remain unscreened and/or unaware of their diagnosis. While prediabetes/T2D screening, also known as glycemic screening, is endorsed in national guidelines, there is almost no research on how to increase screening rates, or evaluations of interventions testing the effectiveness of screening promotion strategies. The American Medical Association has published prediabetes quality measures that apply to UCLA Health as well as all other health systems, specifically tracking the percentage of adult patients with risk factors for T2D due for glycemic screening for whom the screening process was initiated. However, there is no current systemic effort underway at UCLA, or most other health systems, to encourage glycemic screening. We are proposing a pilot trial of the first SMART (Sequential Multiple Assignment Randomized Trial) for glycemic screening. Our SMART experiment will provide preliminary feasibility and acceptability data for a larger, multisite trial that will provide vital guidance to optimize screening approaches for a growing number of screening-eligible patients so that they may seek earlier detection, treatment, and/or access to lifestyle programs and interventions for T2D or prediabetes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on screening methods for type 2 diabetes, so it's best to ask the trial organizers for more details.

Is it safe to use outreach methods like mailed letters, patient portal messages, and text messages for diabetes screening?

The studies reviewed do not report any safety concerns related to using mailed letters, patient portal messages, or text messages for diabetes screening. These methods are generally considered safe for communicating health information and encouraging health behaviors. ^{1 2 3 4 5}

How does the treatment of mailed letters, patient portal messages, and text messages for type 2 diabetes screening differ from other treatments?

This treatment is unique because it focuses on outreach methods like mailed letters, patient portal messages, and text messages to encourage people to get screened for type 2 diabetes, rather than directly treating the condition. It aims to increase awareness and participation in screening, which can lead to early detection and management of diabetes. ^{1 3 6 7 8}

What data supports the effectiveness of the treatment Mailed letter, Patient portal message, Text message for Type 2 Diabetes Screening?

Research shows that text messages can effectively encourage people to manage their diabetes and improve health behaviors, such as medication adherence and glucose control. Additionally, using letters and secure messages has been effective in inviting people to participate in diabetes screening. ^{1 2 3 4 5}

Who Is on the Research Team?

Obidiugwu K Duru, MD, MS

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for overweight or obese individuals who haven't been screened for type 2 diabetes (T2D) or prediabetes and don't already have T2D. Participants should not have had an A1c test in the past three years.

Inclusion Criteria

I am overweight or obese.

Exclusion Criteria

I have type 2 diabetes with a recent A1c test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive glycemic screening invitations via text or patient portal, followed by a mailed letter if not screened within 60 days

60 days

Remote communication

Follow-up

Participants are monitored for receipt of hemoglobin A1c screening and complete an acceptability survey

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Mailed letter
• Patient portal message
• Text message

Trial Overview The study tests different ways to encourage glycemic screening by randomly assigning participants to receive a mailed letter, a text message, or a patient portal message. It's part of research on how best to promote early detection and treatment of T2D.

How Is the Trial Designed?

Group I: Initial text, follow-up text, letter Experimental Treatment 2 Interventions

Participants are initially randomized to glycemic screening invitations by text, and then if they are not screened within 30 days, then they are re-rerandomized to another glycemic screening invitation by text. If they are still not screened in another 30 days then they receive a mailed letter encouraging glycemic screening.

Group II: Initial text, follow-up portal, letter Experimental Treatment 3 Interventions

Participants are initially randomized to glycemic screening invitations by text, and then if they are not screened within 30 days, then they are re-rerandomized to another glycemic screening invitation by patient portal. If they are still not screened in another 30 days then they receive a mailed letter encouraging glycemic screening.

Group III: Initial portal, follow-up text, letter Experimental Treatment 3 Interventions

Participants are initially randomized to glycemic screening invitations by patient portal, and then if they are not screened within 30 days, then they are re-rerandomized to another glycemic screening invitation by text. If they are still not screened in another 30 days then they receive a mailed letter encouraging glycemic screening.

Group IV: Initial portal, follow-up portal, letter Experimental Treatment 2 Interventions

Participants are initially randomized to glycemic screening invitations by patient portal, and then if they are not screened within 30 days, then they are re-rerandomized to another glycemic screening invitation by patient portal. If they are still not screened in another 30 days then they receive a mailed letter encouraging glycemic screening.

Group V: Usual care Active Control 1 Intervention

Patients do not receive any glycemic screening invitations

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

A new trial is testing the effectiveness of SMS text messages designed to improve medication adherence in adults with type 2 diabetes, involving 958 participants over 12 months, aiming to reduce cardiovascular risk.

Preliminary feasibility studies indicate that these SMS messages are acceptable to patients and successfully influence medication adherence, setting the stage for this larger trial to assess their impact compared to usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting People With Type 2 Diabetes in the Effective Use of Their Medicine Through Mobile Health Technology Integrated With Clinical Care to Reduce Cardiovascular Risk: Protocol for an Effectiveness and Cost-effectiveness Randomized Controlled Trial. Farmer, A., Jones, L., Newhouse, N., et al.[2023]

A study involving 36 adult patients without diabetes found that participants were generally receptive to receiving text messages for HbA1c screening, indicating a potential for mobile health interventions to increase diabetes screening rates.

Key factors for improving engagement included using plain language, personalizing messages, and clearly outlining the steps for screening, as well as considering the patient's relationship with their healthcare provider.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Perspectives on a Targeted Text Messaging Campaign to Encourage Screening for Diabetes: Qualitative Study. Lenoir, KM., Sandberg, JC., Miller, DP., et al.[2023]

A text messaging program (TMP) significantly improved glucose control and retinopathy screening rates in a study of 20 patients with uncontrolled type 2 diabetes over 3 months.

More than 70% of participants reported positive changes in their self-care behaviors, suggesting that using technology can effectively support diabetes management, especially for those with limited access to healthcare education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text Messaging in the Patient-Centered Medical Home to Improve Glucose Control and Retinopathy Screening. Miller, JM., Phalen, AG., Crawford, A., et al.[2020]

Supplemental text messaging (SMS4PreDM) was appealing to participants, particularly younger individuals and those from underserved populations, but it did not significantly enhance attendance or weight loss outcomes in the in-person National Diabetes Prevention Program (NDPP).

The study involved 488 participants over a year, comparing those who received in-person NDPP classes with and without the SMS4PreDM support, highlighting the need for further research to find effective strategies for improving NDPP outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supplemental Text Message Support With the National Diabetes Prevention Program: Pragmatic Comparative Effectiveness Trial. Ritchie, ND., Gutiérrez-Raghunath, S., Durfee, MJ., et al.[2021]

Citations

1. Canada pubmed.ncbi.nlm.nih.gov

Supporting People With Type 2 Diabetes in the Effective Use of Their Medicine Through Mobile Health Technology Integrated With Clinical Care to Reduce Cardiovascular Risk: Protocol for an Effectiveness and Cost-effectiveness Randomized Controlled Trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Employer-Based Screening for Diabetes and Prediabetes in an Integrated Health Care Delivery System: A Natural Experiment for Translation in Diabetes (NEXT-D) Study. [2019]

3. Canada pubmed.ncbi.nlm.nih.gov

Patient Perspectives on a Targeted Text Messaging Campaign to Encourage Screening for Diabetes: Qualitative Study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Text Messaging in the Patient-Centered Medical Home to Improve Glucose Control and Retinopathy Screening. [2020]

5. Canada pubmed.ncbi.nlm.nih.gov

Supplemental Text Message Support With the National Diabetes Prevention Program: Pragmatic Comparative Effectiveness Trial. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Text Message Intervention for Latino Adults to Improve Diabetes Outcomes. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Designing Patient-Centered Text Messaging Interventions for Increasing Physical Activity Among Participants With Type 2 Diabetes: Qualitative Results From the Text to Move Intervention. [2023]

8. Ireland pubmed.ncbi.nlm.nih.gov

Evaluation of an informed choice invitation for type 2 diabetes screening. [2022]