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

Primary Purpose

Diabetes Mellitus, Type 2, Diabetes Education, Lifestyle Modification

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diabetes education web site application
Sponsored by
The Reading Hospital and Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 diabetes, Type II diabetes, uncontrolled type 2 diabetes, hyperglycemia, mobile web application, Diabetes education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Reading Hospital, an affiliate of Tower Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention arm

Control arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hemoglobin A1c
Blood Test
"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.

Secondary Outcome Measures

Body Mass Index
Height-to-weight ratio, an indicator of underweight, normal weight, or overweight/obese
Blood pressure
Systolic and Diastolic

Full Information

First Posted
May 30, 2023
Last Updated
August 22, 2023
Sponsor
The Reading Hospital and Medical Center
Collaborators
Reading Hospital Foundation, Complete Statistical Services (Consult-Stat)
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1. Study Identification

Unique Protocol Identification Number
NCT05893927
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Reading Hospital and Medical Center
Collaborators
Reading Hospital Foundation, Complete Statistical Services (Consult-Stat)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants will be recruited to participate in the study, and then randomized to one of two arms.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Diabetes education web site application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hemoglobin A1c
Description
Blood Test
Time Frame
6 months
Title
"Self-Efficacy for Diabetes Scale"
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Body Mass Index
Description
Height-to-weight ratio, an indicator of underweight, normal weight, or overweight/obese
Time Frame
6 months
Title
Blood pressure
Description
Systolic and Diastolic
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary E Alderfer, MSN
Phone
484-628-8360
Email
mary.alderfer@towerhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Pamela Marrero
Phone
484-628-8355
Email
pamela.marrero@towerhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis A Murillo, MD, MPH
Organizational Affiliation
Reading Hospital Tower Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reading Hospital, an affiliate of Tower Health
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research coordinator
Phone
484-628-8585
Email
research@towerhealth.org
First Name & Middle Initial & Last Name & Degree
Luis A Murillo, MD, MPH
First Name & Middle Initial & Last Name & Degree
Sally Snyder, MSN

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30963188
Citation
Shan R, Sarkar S, Martin SS. Digital health technology and mobile devices for the management of diabetes mellitus: state of the art. Diabetologia. 2019 Jun;62(6):877-887. doi: 10.1007/s00125-019-4864-7. Epub 2019 Apr 8.
Results Reference
background
PubMed Identifier
34335428
Citation
Ball E, Rivas C. Health Apps Require Co-development to Be Acceptable and Effective. Front Psychol. 2021 Jul 16;12:714453. doi: 10.3389/fpsyg.2021.714453. eCollection 2021. No abstract available.
Results Reference
background
PubMed Identifier
28527495
Citation
Kao CK, Liebovitz DM. Consumer Mobile Health Apps: Current State, Barriers, and Future Directions. PM R. 2017 May;9(5S):S106-S115. doi: 10.1016/j.pmrj.2017.02.018.
Results Reference
background
PubMed Identifier
33384470
Citation
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.
Results Reference
background
PubMed Identifier
29390917
Citation
Ye Q, Khan U, Boren SA, Simoes EJ, Kim MS. An Analysis of Diabetes Mobile Applications Features Compared to AADE7: Addressing Self-Management Behaviors in People With Diabetes. J Diabetes Sci Technol. 2018 Jul;12(4):808-816. doi: 10.1177/1932296818754907. Epub 2018 Feb 1.
Results Reference
background
PubMed Identifier
28249834
Citation
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.
Results Reference
background
PubMed Identifier
33298417
Citation
American Diabetes Association. 6. Glycemic Targets: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S73-S84. doi: 10.2337/dc21-S006.
Results Reference
background
PubMed Identifier
27861583
Citation
Cui M, Wu X, Mao J, Wang X, Nie M. T2DM Self-Management via Smartphone Applications: A Systematic Review and Meta-Analysis. PLoS One. 2016 Nov 18;11(11):e0166718. doi: 10.1371/journal.pone.0166718. eCollection 2016.
Results Reference
background
PubMed Identifier
34324218
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.
Results Reference
background
PubMed Identifier
17679641
Citation
Jeste DV, Palmer BW, Appelbaum PS, Golshan S, Glorioso D, Dunn LB, Kim K, Meeks T, Kraemer HC. A new brief instrument for assessing decisional capacity for clinical research. Arch Gen Psychiatry. 2007 Aug;64(8):966-74. doi: 10.1001/archpsyc.64.8.966.
Results Reference
background
Citation
Beckerle CM, Lavin MA. Association of Self-Efficacy and Self-Care With Glycemic Control in Diabetes. Diabetes Spectrum. 2013; 26(3): 172-178
Results Reference
background
Links:
URL
https://www.pewresearch.org/internet/fact-sheet/mobile/
Description
Mobile Fact Sheet from Pew Research Center, published April 07, 2021

Learn more about this trial

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

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