Impact of a Diabetes Education Mobile Web Application on Patients With Uncontrolled Type 2 Diabetes

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus, Type 2; Diabetes Education; Lifestyle Modification

• Registration Number: NCT05893927
• Lead Sponsor: The Reading Hospital and Medical Center

Brief Summary

The goal of this clinical trial is to evaluate the use and effectiveness of a mobile web application (app) that is designed to educate and allow patients to manage diabetes and make sustainable lifestyle changes, and to study the impact of the app on clinical outcomes of diabetes (HA1C) and educational outcomes (Self-Efficacy for Diabetes Scale). The main question to answer is: Does the use of the Diabetes Application significantly affect clinical outcomes of diabetes and cardiometabolic risk factors (BMI and Blood Pressure)? Patients will be enrolled in one of two available arms of the study.

Participants in the 'intervention arm' will use the app to view educational information presented as videos in the following areas: Healthy Coping, Healthy Eating, Staying Active, Medications (Use and Safety), Problem Solving in Diabetes and Disease Pathophysiology. They will continue routine follow-up care with their primary care physicians during the study.

Participants in the 'control arm' will continue with their primary care physician in routine follow-up care, as normally scheduled.

Researchers will compare the intervention arm participants to the control arm participants to find out about and compare changes in HA1C, systolic blood pressure, diastolic blood pressure, and body mass index. Groups will also be compared on the basis of self-perceived confidence of managing their diabetes by way of the Diabetes Self Efficacy Scale.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-30
• Study First Submitted QC: 2023-05-30
• Study First Posted: 2023-06-08
• Status Verified: 2024-02
• Study Start: 2024-02-15
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Age ≥ 18 years
• Diagnosis of Type 2 Diabetes with HA1c >8.0
• Current patients of the Family Healthcare Center, Reading Hospital Tower health.

Exclusion Criteria

• Identified special populations (pregnancy or individuals currently incarcerated)
• Patients without access to their own smart phone
• Any patient who is unable to provide their own informed consent to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
"Self-Efficacy for Diabetes Scale"	6 months	A validated (free to use) survey that examines self-perceived ability to manage diabetes. Scores are reported on a scale from 1-10. 1 reflecting Not at all confident and 10 reflecting confident. The minimum total value is 8, and the maximum value is 80. A higher score indicates that the individual has a better outcome, i.e., more confident that he/she can perform the task regularly at the present time.
Hemoglobin A1c	6 months	Blood Test

Secondary Outcome Measures

Name	Time	Method
Body Mass Index	6 months	Height-to-weight ratio, an indicator of underweight, normal weight, or overweight/obese
Blood pressure	6 months	Systolic and Diastolic

Trial Locations

Locations (1)

Reading Hospital, an affiliate of Tower Health; 🇺🇸 West Reading, Pennsylvania, United States