Diabetes Management Program for Hispanic/Latino
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|ClinicalTrials.gov Identifier: NCT03960424|
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : September 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus Type 2 Diabetes||Other: Comprehensive Outpatient Management Behavioral: Diabetes Telemonitoring||Not Applicable|
The investigators propose a multiphase mixed method, Comparative Effectiveness Research Randomized Control Trial (CER RCT) to:
Specific Aim 1: Assess usability of an evidence-based DTM intervention utilizing a Community Based Participatory Research (CBPR) approach and adapt it to facilitate acceptability and feasibility in a population of H/L patients with T2D, and their caregivers and providers.
Specific Aim 2: Assess whether H/L patients receiving DTM attain significantly improved patient-centered outcomes compared to COM, through a CER RCT. Expected outcomes include improved diabetes quality of life (QoL), glucose management (GM), blood pressure (BP), cholesterol, medication adherence, and diabetes self-efficacy (SE), and reduced diabetes distress, problem areas in diabetes (PAID), inpatient utilization, unscheduled T2D physician visits and sick days.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Mixed Methods Design, incorporating adaptations before RCT trial commencement.|
|Masking:||None (Open Label)|
|Official Title:||Diabetes Management Program for Hispanic/Latino|
|Actual Study Start Date :||September 30, 2019|
|Estimated Primary Completion Date :||May 1, 2022|
|Estimated Study Completion Date :||June 30, 2022|
Experimental: Diabetes Telemonitoring (DTM)
Diabetes Telehealth Management (DTM), based on the 2018 ADA Standards for Type 2 Diabetes (T2D), uses smart devices to share information between patients, caregivers, and clinicians. DTM includes:1) weekly real time "virtual" visit between patient and clinician 2) vital signs monitoring/interpretation 3) diabetes management 4) patient interactive educational videos and "teach back" quizzes, reinforcing self-management strategies 5) a caregiver app with supportive capability.
Behavioral: Diabetes Telemonitoring
Diabetes Telehealth Management (DTM), based on the 2018 ADA Standards for T2D, uses smart devices to share information between patients, caregivers, and clinicians.
Other Name: DTM
Active Comparator: Comprehensive Outpatient Management (COM)
Comprehensive Outpatient Management (COM) is the most realistic evidence-based comparator, in that it is the most frequently recommended and used option for US T2D patients. COM, like DTM, is consistent with the 2018 American Diabetes Association (ADA) Standards which include, but are not limited to, past medical and family history, social history, medications, screening, physical examination, laboratory evaluation, etc.Patients are instructed to monitor blood glucose (within physician recommendations), and have routine or "well" visits every 3 months. Patients can set appointments with a T2D educator. COM patients will receive monthly calls from the study Registered Nurse (RN) to collect data.
Other: Comprehensive Outpatient Management
Patients receiving comprehensive outpatient management experience typical care received in the outpatient setting.
Other Name: COM
- Hemoglobin A1C [ Time Frame: 6 months ]HbA1c
- HbA1c [ Time Frame: 12 months ]Hemoglobin A1c
- Hypoglycemia episodes [ Time Frame: 6 months ]Number of hypoglycemia episodes
- Adherence [ Time Frame: 6 months ]Adherence to Refills and Medications - Diabetes (ARMS-D)
- Diabetes self-efficacy [ Time Frame: 6 months ]Diabetes Self-Efficacy Scale
- PAID [ Time Frame: 6 months ]Problem Areas in Diabetes Scale
- Weight [ Time Frame: 6 months ]lbs
- Cholesterol [ Time Frame: 6 months ]Changes in cholesterol over time
- Blood Pressure [ Time Frame: 6 months ]BP
- Diabetes Quality of life [ Time Frame: 6 months ]Diabetes-39 is a validated instrument specifically designed to measure quality of life for diabetes patients
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): NCT03960424
|Contact: Diane Marbury, CRA||(516) firstname.lastname@example.org|
|Contact: Myia Williams, PhDemail@example.com|
|United States, New York|
|Feinstein Institute of Medical Research||Recruiting|
|Manhasset, New York, United States, 11030|
|Contact: Renee Pekmezaris, PhD 516-600-1402 firstname.lastname@example.org|
|Contact: Myia Williams, PhD 516-600-1485 email@example.com|
|Principal Investigator: Renee Pekmezaris, PhD|
|Principal Investigator:||Renee Pekmezaris, PhD||Feinstein Institute for Medical Research|