Clinical trial NCT06695533: I Can Do This! Managing My Diabetes
Official title: "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"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Keywords: Diabetes self-management
Patient education
Glycemic control
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Georgia Center for Diabetes Translation Research
First posted: 2024-11-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The workbook will be designed with the help of 5 focus group discussions. Five focus groups will include participants from one of the following categories: patients, caregivers, providers, and diabetes educators. Each focus group will have 6-10 participants.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goals of this study are to:

1. Co-develop a user-friendly word game-based workbook format for patients with diabetes to understand how to manage their diabetes. For this study, the first section of the workbook will be developed to teach carbohydrate management.
2. Assess the feasibility and acceptability of the workbook.
3. Understand the implementation challenges that will be important for improving the workbook and preparing it for larger-scale effectiveness research.

Participants will be asked to:

* Complete the workbook during their waiting time in the clinic or at home.
* Engage in word games designed to teach diabetes management vocabulary and concepts.
* Attend follow-up sessions to assess changes in self-efficacy and glycemic control.

Detailed description: Diabetes poses a significant public health challenge in the U.S., affecting approximately 37 million people, or 11% of the population. The prevalence is rising, particularly among youth, with a forecasted 700% increase in type 2 diabetes cases by 2060. Diabetes leads to severe health complications, including increased risks of heart attacks, strokes, and kidney failure, and affects nearly 1 million people worldwide with vision loss. Many individuals struggle to manage their diabetes effectively; only about 50% achieve proper glycemic control.

Diabetes self-management education is crucial for improving self-efficacy and adherence to treatment, yet only 5-7% of eligible patients receive this education. The American Diabetes Association advocates for individualized nutrition therapy, but access remains limited, especially for uninsured populations, exacerbating health disparities.

To address this gap, a novel word game-based workbook is proposed to enhance diabetes self-efficacy. This workbook can be used in waiting rooms or at home, offering an engaging way to learn about diabetes management through word games and puzzles. It aims to provide accessible education for underserved communities, improve glycemic control, and ultimately reduce diabetes-related disparities.

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

Primary outcomes:
measure: Diabetes self-efficacy score (Diabetes management self-efficacy (DMSE)
timeFrame: Pre test, post test (3months)
measure: Knowledge of American Diabetes Association (ADA) diabetes plate method
timeFrame: Pre test, post test (3months)
measure: Acceptability of Intervention Measure (AIM)
timeFrame: Pre test, post test (3months)
measure: Feasibility of Intervention Measure (FIM)
timeFrame: Pre test, post test (3months)
Secondary outcomes:
measure: Change in Hemoglobin A1c
timeFrame: Pre test, post test (3months)
measure: Change in Weight
timeFrame: Pre test, post test (3months)
measure: Change in Blood Pressure
timeFrame: Pre test, post test (3months)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Midtown Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Catherine Park, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Saria Hassan, MD
role: PRINCIPAL_INVESTIGATOR
References: