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

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ClinicalTrials.gov Identifier: NCT05893927
Recruitment Status : Not yet recruiting
First Posted : June 8, 2023
Last Update Posted : August 24, 2023
Sponsor:
Collaborators:
Reading Hospital Foundation
Complete Statistical Services (Consult-Stat)
Information provided by (Responsible Party):
Luis Murillo, The Reading Hospital and Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Diabetes Education Lifestyle Modification Other: Diabetes education web site application Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Participants will be recruited to participate in the study, and then randomized to one of two arms.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluating the Clinical Impact of a PCP Developed Diabetes Education Mobile Web Application on Patients With Uncontrolled Type 2 Diabetes
Estimated Study Start Date : September 15, 2023
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : September 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention arm
Participants enrolled in the intervention arm will be given a 6-month access period to the diabetes education application designed by the study team. The web site will offer videos related to a specific areas of education concerning diabetes self-management. To encourage compliance, participant users will receive weekly notifications from the application that will guide them through viewing all videos in the series. Participants will continue routine follow-up appointments with their primary care physicians during the study period. There will be no restrictions on starting or stopping medications during the study period.
 Other: Diabetes 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.
No Intervention: Control arm
Participants in the control arm will not have access to the Diabetes Application. They will continue follow-up appointments according to the standard of care with their primary care physician, diabetic educators, etc. There are no restrictions on starting or stopping medications for patients within the control arm.


Outcome Measures
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Primary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: 6 months ]
    Blood Test

  2. "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 Outcome Measures :
  1. Body Mass Index [ Time Frame: 6 months ]
    Height-to-weight ratio, an indicator of underweight, normal weight, or overweight/obese

  2. Blood pressure [ Time Frame: 6 months ]
    Systolic and Diastolic


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05893927


Contacts
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Contact: Mary E Alderfer, MSN 484-628-8360 mary.alderfer@towerhealth.org
Contact: Pamela Marrero 484-628-8355 pamela.marrero@towerhealth.org

Locations
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United States, Pennsylvania
Reading Hospital, an affiliate of Tower Health
West Reading, Pennsylvania, United States, 19611
Contact: Research coordinator    484-628-8585    research@towerhealth.org   
Principal Investigator: Luis A Murillo, MD, MPH         
Sub-Investigator: Sally Snyder, MSN         
Sponsors and Collaborators
The Reading Hospital and Medical Center
Reading Hospital Foundation
Complete Statistical Services (Consult-Stat)
Investigators
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Principal Investigator: Luis A Murillo, MD, MPH Reading Hospital Tower Health
More Information
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Additional Information:

Publications:
Beckerle CM, Lavin MA. Association of Self-Efficacy and Self-Care With Glycemic Control in Diabetes. Diabetes Spectrum. 2013; 26(3): 172-178

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Responsible Party: Luis Murillo, Residency Faculty Associate, Director Hanna Center for Primary Care Research, The Reading Hospital and Medical Center
ClinicalTrials.gov Identifier: NCT05893927    
Other Study ID Numbers: 2023-020
First Posted: June 8, 2023    Key Record Dates
Last Update Posted: August 24, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Luis Murillo, The Reading Hospital and Medical Center:
Type 2 diabetes
Type II diabetes
uncontrolled type 2 diabetes
 hyperglycemia
mobile web application
Diabetes education
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases