Impact of a Virtual Diabetes Self-Care and Education Program on Diabetes-related Outcomes in Latinos With T2 Diabetes
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|ClinicalTrials.gov Identifier: NCT02488785|
Recruitment Status : Completed
First Posted : July 2, 2015
Last Update Posted : August 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Behavioral: Virtual Diabetes Self-Care and Education Program Device: Fitbit Device: Smartphone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||107 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Impact of a Comprehensive Virtual Diabetes Self-Care and Education Program on Diabetes-related Outcomes in Latinos With Type 2 Diabetes|
|Actual Study Start Date :||June 2015|
|Actual Primary Completion Date :||March 31, 2017|
|Actual Study Completion Date :||November 30, 2017|
No Intervention: Control
Patients in this group will attend regular clinical and education appointments as offered by the clinic for their diabetes care.
Patients in this group will be part of a Virtual Diabetes Self-Care and Education Program. They will receive a phone to communicate with a diabetes educator for 6 months. They will connect with the diabetes educator for weekly video conferences of up to 30 minutes for twelve consecutive weeks, followed by 7 phone calls. Additionally, they will receive a weekly text message about diabetes for 6 months.
Behavioral: Virtual Diabetes Self-Care and Education Program
Participants will be able to have frequent contact in order to share physical activity and glucose data with the diabetes educator using the smartphone they will receive. Information downloaded to the Glooko Population Management tool can be shared with the diabetes educator.
Participants will be given a Fitbit physical activity tracker which they can use to record their activity and share the information with the diabetes educator using the device's smartphone application.
Other Name: physical activity tracker
All virtual visits were performed via provided smartphone. In addition, participants will receive a Glooko MeterSync Blue cable which is able to connect to most glucose meters in order to download glucose data to the Glooko Population Management tool on their smartphones
- Hemoglobin A1c [ Time Frame: 9 months ]The A1C test is a blood test used to diagnose type 2 diabetes and then to manage diabetes. It is measured as a percent.
- Number of participants who adhere to medications [ Time Frame: 9 months ]Evaluated using the Morisky Medication Adherence Scale
- Number of participants with diabetes related emotional distress [ Time Frame: 6 months ]Evaluated using the Problem Areas in Diabetes Questionnaire (PAID)
- Number of participants with adequate self-care [ Time Frame: 9 months ]Evaluated using the Self Care Inventory - Revised (SCI-R)
- Number of participants with depression [ Time Frame: 6 months ]Evaluated using the Patient Health Questionnaire - 9 (PHQ-9)
- Number of participants with anxiety [ Time Frame: 6 months ]Evaluated using the Generalized Anxiety Disorder - 7 (GAD-7)
- Number of physically active participants [ Time Frame: 9 months ]Assessed using a physical activity tracker
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): NCT02488785
|United States, Texas|
|Doctors Hospital at Renaissance|
|Edinburg, Texas, United States, 78539|
|Principal Investigator:||Sylvia E Rosas, MD||Joslin Diabetes Center|
|Principal Investigator:||Marcel Twahirwa, MD||Doctors Hospital at Reinassance|