Diabetes Management Program for Hispanic/Latino
- Conditions
- Type 2 DiabetesType 2 Diabetes Mellitus
- Interventions
- Other: Comprehensive Outpatient ManagementBehavioral: Diabetes Telemonitoring
- Registration Number
- NCT03960424
- Lead Sponsor
- Northwell Health
- Brief Summary
To compare Diabetes Telemonitoring to comprehensive outpatient management (COM) on critical patient-centered outcomes, including HbA1c.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
- Hispanic patients with a diagnosis of diabetes
- Speaks English or Spanish
- Patient is not Hispanic
- Patient does not have a diagnosis of diabetes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Comprehensive Outpatient Management (COM) Comprehensive Outpatient Management 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. Diabetes Telemonitoring (DTM) Diabetes Telemonitoring 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.
- Primary Outcome Measures
Name Time Method Hemoglobin A1C 6 months HbA1c
- Secondary Outcome Measures
Name Time Method HbA1c 12 months Hemoglobin A1c
Hypoglycemia episodes 6 months Number of hypoglycemia episodes
Diabetes self-efficacy 6 months Diabetes Self-Efficacy Scale
Blood Pressure 6 months BP
Adherence 6 months Adherence to Refills and Medications - Diabetes (ARMS-D)
Weight 6 months lbs
Cholesterol 6 months Changes in cholesterol over time
Diabetes Quality of life 6 months Diabetes-39 is a validated instrument specifically designed to measure quality of life for diabetes patients
PAID 6 months Problem Areas in Diabetes Scale
Trial Locations
- Locations (1)
Feinstein Institute of Medical Research
🇺🇸Manhasset, New York, United States