Viewing Study NCT06695533


Ignite Creation Date: 2025-12-25 @ 3:01 AM
Ignite Modification Date: 2025-12-31 @ 10:32 PM
Study NCT ID: NCT06695533
Status: NOT_YET_RECRUITING
Last Update Posted: 2025-07-28
First Post: 2024-11-16
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: I Can Do This! Managing My Diabetes
Sponsor: Emory University
Organization:

Study Overview

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"
Status: NOT_YET_RECRUITING
Status Verified Date: 2025-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: