Diabetes Management Program for Hispanic/Latino

Sponsor

Northwell Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT03960424

Collaborator

Patient-Centered Outcomes Research Institute (Other)

240

Enrollment

Location

Arms

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare Diabetes Telemonitoring to comprehensive outpatient management (COM) on critical patient-centered outcomes, including HbA1c.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus Type 2 Diabetes	Other: Comprehensive Outpatient Management Behavioral: Diabetes Telemonitoring	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Mixed Methods Design, incorporating adaptations before RCT trial commencement.Mixed Methods Design, incorporating adaptations before RCT trial commencement.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Diabetes Management Program for Hispanic/Latino

Actual Study Start Date :

Sep 30, 2019

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: COM

Arm

Intervention/Treatment

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 Names:

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 Names:

COM

Outcome Measures

Primary Outcome Measures

Hemoglobin A1C [6 months]
HbA1c

Secondary Outcome Measures

HbA1c [12 months]
Hemoglobin A1c
Hypoglycemia episodes [6 months]
Number of hypoglycemia episodes
Adherence [6 months]
Adherence to Refills and Medications - Diabetes (ARMS-D)
Diabetes self-efficacy [6 months]
Diabetes Self-Efficacy Scale
PAID [6 months]
Problem Areas in Diabetes Scale
Weight [6 months]
lbs
Cholesterol [6 months]
Changes in cholesterol over time
Blood Pressure [6 months]
BP
Diabetes Quality of life [6 months]
Diabetes-39 is a validated instrument specifically designed to measure quality of life for diabetes patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Hispanic patients with a diagnosis of diabetes
Speaks English or Spanish

Exclusion Criteria:

Patient is not Hispanic
Patient does not have a diagnosis of diabetes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Feinstein Institute of Medical Research	Manhasset	New York	United States	11030

Sponsors and Collaborators

Northwell Health
Patient-Centered Outcomes Research Institute

Investigators

Principal Investigator: Renee Pekmezaris, PhD, Feinstein Institute for Medical Research

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Northwell Health

ClinicalTrials.gov Identifier:

NCT03960424

Other Study ID Numbers:

AD-2017C3-9185

First Posted:

May 23, 2019

Last Update Posted:

Sep 13, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Sep 13, 2021