Diabetes Education, Diabetes Mellitus, Type 2, Lifestyle Modification
Conditions
Keywords
Type 2 diabetes, Type II diabetes, uncontrolled type 2 diabetes, hyperglycemia, mobile web application, Diabetes education
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.
Interventions
OTHERDiabetes education web site application
The Diabetes education website application will contain informational videos for this protocol. The videos will include a welcome video and the categorical topics of Healthy Coping, Healthy Eating, Staying Active, Medications (Use and Safety), Problem Solving in Diabetes, and Disease Pathophysiology. Each category contains several videos providing education about a different component of diabetes care.
Sponsors
Reading Hospital Foundation
Complete Statistical Services (Consult-Stat)
The Reading Hospital and Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants will be recruited to participate in the study, and then randomized to one of two arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | 6 months | Blood Test |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index | 6 months | Height-to-weight ratio, an indicator of underweight, normal weight, or overweight/obese |
Countries
United States
Contacts
Primary ContactMary E Alderfer, MSN
Backup ContactPamela Marrero
Outcome results
None listed