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Clinical Trials/NCT05893927
NCT05893927
Recruiting
Not Applicable

Evaluating the Clinical Impact of a PCP Developed Diabetes Education Mobile Web Application on Patients With Uncontrolled Type 2 Diabetes

The Reading Hospital and Medical Center1 site in 1 country65 target enrollmentFebruary 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
The Reading Hospital and Medical Center
Enrollment
65
Locations
1
Primary Endpoint
Hemoglobin A1c
Status
Recruiting
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 15, 2024
End Date
September 30, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Luis Murillo

Residency Faculty Associate, Director Hanna Center for Primary Care Research

The Reading Hospital and Medical Center

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

Outcomes

Primary Outcomes

Hemoglobin A1c

Time Frame: 6 months

Blood Test

"Self-Efficacy for Diabetes Scale"

Time Frame: 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 Outcomes

  • Body Mass Index(6 months)

Study Sites (1)

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