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| Name | Class |
|---|---|
| Reading Hospital Foundation | UNKNOWN |
| Complete Statistical Services (Consult-Stat) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | 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. |
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| Control arm | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes education web site application | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c | Blood Test | 6 months |
| "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 |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index | Height-to-weight ratio, an indicator of underweight, normal weight, or overweight/obese | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary E Alderfer, MSN | Contact | 484-628-8360 | mary.alderfer@towerhealth.org | |
| Pamela Marrero | Contact | 484-628-8355 | pamela.marrero@towerhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Luis A Murillo, MD, MPH | Reading Hospital Tower Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reading Hospital, an affiliate of Tower Health | Recruiting | West Reading | Pennsylvania | 19611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30963188 | Background | 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. | |
| 34335428 | Background | 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. |
| Label | URL |
|---|---|
| Mobile Fact Sheet from Pew Research Center, published April 07, 2021 | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Participants will be recruited to participate in the study, and then randomized to one of two arms.
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| 28527495 | Background | 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. |
| 33384470 | Background | 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. |
| 29390917 | Background | 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. |
| 28249834 | Background | 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. |
| 33298417 | Background | 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. |
| 27861583 | Background | 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. |
| 34324218 | Background | 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. |
| 17679641 | Background | 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. |
| Background | Beckerle CM, Lavin MA. Association of Self-Efficacy and Self-Care With Glycemic Control in Diabetes. Diabetes Spectrum. 2013; 26(3): 172-178 |
| D004700 | Endocrine System Diseases |