Clinical trial NCT05893927: Impact of a Diabetes Education Mobile Web Application on Patients With Uncontrolled Type 2 Diabetes
Official title: Evaluating the Clinical Impact of a PCP Developed Diabetes Education Mobile Web Application on Patients With Uncontrolled Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Diabetes Education
Lifestyle Modification
Keywords: Type 2 diabetes
Type II diabetes
uncontrolled type 2 diabetes
hyperglycemia
mobile web application
Diabetes education
Lead sponsor: The Reading Hospital and Medical Center
Sponsor class: OTHER
Collaborators: name: Reading Hospital Foundation
name: Complete Statistical Services (Consult-Stat)
First posted: 2023-06-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be recruited to participate in the study, and then randomized to one of two arms.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 6 months
measure: "Self-Efficacy for Diabetes Scale"
timeFrame: 6 months
Secondary outcomes:
measure: Body Mass Index
timeFrame: 6 months
measure: Blood pressure
timeFrame: 6 months
Other outcomes:
Locations:
city: West Reading
country: United States
facility: Reading Hospital, an affiliate of Tower Health
state: Pennsylvania
Study officials:
affiliation: Reading Hospital Tower Health
name: Luis A Murillo, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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