Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Evaluating the Clinical Impact of a PCP Developed Diabetes Education Mobile Web Application on Patients With Uncontrolled Type 2 Diabetes
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | September 30, 2025 |
Est. primary completion date | September 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Reading Hospital, an affiliate of Tower Health | West Reading | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
The Reading Hospital and Medical Center | Complete Statistical Services (Consult-Stat), Reading Hospital Foundation |
United States,
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Bonoto BC, de Araujo VE, Godoi IP, de Lemos LL, Godman B, Bennie M, Diniz LM, Junior AA. Efficacy of Mobile Apps to Support the Care of Patients With Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. JMIR Mhealth Uhealth. 2017 Mar 1;5(3):e4. doi: 10.2196/mhealth.6309. — View Citation
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Doyle-Delgado K, Chamberlain JJ. Use of Diabetes-Related Applications and Digital Health Tools by People With Diabetes and Their Health Care Providers. Clin Diabetes. 2020 Dec;38(5):449-461. doi: 10.2337/cd20-0046. — View Citation
He Q, Zhao X, Wang Y, Xie Q, Cheng L. Effectiveness of smartphone application-based self-management interventions in patients with type 2 diabetes: A systematic review and meta-analysis of randomized controlled trials. J Adv Nurs. 2022 Feb;78(2):348-362. doi: 10.1111/jan.14993. Epub 2021 Jul 29. — View Citation
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hemoglobin A1c | Blood Test | 6 months | |
Primary | "Self-Efficacy for Diabetes Scale" | 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. | 6 months | |
Secondary | Body Mass Index | Height-to-weight ratio, an indicator of underweight, normal weight, or overweight/obese | 6 months | |
Secondary | Blood pressure | Systolic and Diastolic | 6 months |
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