A workbook to help manage diabetes through word games

"I Can Do This! Managing My Diabetes: a Pilot Project Using a Novel Word Game-based Workbook Intervention to Allow People Living with Diabetes to Increase Their Diabetes Self-efficacy"

This study is testing a fun workbook with word games to help people with diabetes learn how to manage their carbs better and feel more confident in their health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Emory University (Academic / other)
• Locations: 1 site (Atlanta, Georgia)
• Trial ID: NCT06695533 on ClinicalTrials.gov

What this trial studies

This study aims to develop a user-friendly workbook that utilizes word games to educate patients with diabetes on carbohydrate management. Participants will engage with the workbook during clinic visits or at home, completing activities designed to enhance their understanding of diabetes management. The study will assess the feasibility and acceptability of the workbook, as well as identify implementation challenges to prepare for future effectiveness research. By focusing on underserved communities, the study seeks to improve self-efficacy and glycemic control among individuals with diabetes.

Who should consider this trial

Good fit: Ideal candidates include adults with type 2 diabetes who are not insulin-dependent and have a hemoglobin A1c less than 10%.

Not a fit: Patients who cannot read or speak English, are unwilling to participate in group discussions, or are pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance diabetes self-management education and improve glycemic control for patients.

How similar studies have performed: Other studies have shown success in using educational interventions to improve diabetes management, making this approach promising yet innovative.

Eligibility criteria

Inclusion Criteria:

Focus group inclusion:

1. Patients: adult with diabetes and patient at the Midtown Clinic
2. Caregivers: partner, or caregiver of a patient with diabetes
3. Providers: Physician Assistant (PA), Nurse Practitioner (NP), or MD who cares for patients with diabetes
4. Diabetes educators: diabetes educator

Focus group exclusion:

1. Cannot speak/read English
2. Unwilling to participate in group discussion
3. Pregnancy

Aim 2 inclusion criteria:

1. Having type 2 diabetes which is not insulin dependent since insulin management adds another level of diabetes self-management that would confound self-efficacy scores.
2. Having a hemoglobin a1c less than 10% based on their last 3 hemoglobin a1c readings within the 2 years before the recruitment phase of the study. The ADA recommends the initiation of insulin therapy for individuals with a hemoglobin a1c above 10%, therefore the study will focus on an intervention for diabetes before insulin is likely to be part of the management plan.
3. Not having any conditions that could interfere with the accuracy of a hemoglobin a1c result: anemia, hemoglobinopathy, end-stage renal disease, chronic liver disease.
4. The ability to read a passage set at a fifth-grade literacy, a score of at least 3 on the Mini-Cog test scale which would represent a lower likelihood of dementia, and the ability to drive to medical visits.
5. Subjects will represent a diversity of age, educational level, and socioeconomic status (will use type of medical insurance as a proxy)

Aim 2 exclusion criteria:

1. Cannot speak/read English
2. Unwilling to return for a follow-up visit in 3 months
3. Pregnancy

Where this trial is running

Atlanta, Georgia

• Emory Midtown Clinic — Atlanta, Georgia, United States (Recruiting)

Study contacts

• Principal investigator: Catherine Park, MD — Emory University
• Study coordinator: Catherine Park, MD

Conditions Diabetes; Diabetes self-management; Patient education; Glycemic control