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Diabetes Management Program for Hispanic/Latino

Primary Purpose

Type 2 Diabetes Mellitus, Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comprehensive Outpatient Management
Diabetes Telemonitoring
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Feinstein Institute of Medical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Diabetes Telemonitoring (DTM)

Comprehensive Outpatient Management (COM)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hemoglobin A1C
HbA1c

Secondary Outcome Measures

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

Full Information

First Posted
May 9, 2019
Last Updated
October 13, 2023
Sponsor
Northwell Health
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03960424
Brief Title
Diabetes Management Program for Hispanic/Latino
Official Title
Diabetes Management Program for Hispanic/Latino
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
March 12, 2023 (Actual)
Study Completion Date
September 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Mixed Methods Design, incorporating adaptations before RCT trial commencement.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diabetes Telemonitoring (DTM)
Arm Type
Experimental
Arm Description
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.
Arm Title
Comprehensive Outpatient Management (COM)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Comprehensive Outpatient Management
Other Intervention Name(s)
COM
Intervention Description
Patients receiving comprehensive outpatient management experience typical care received in the outpatient setting.
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Telemonitoring
Other Intervention Name(s)
DTM
Intervention Description
Diabetes Telehealth Management (DTM), based on the 2018 ADA Standards for T2D, uses smart devices to share information between patients, caregivers, and clinicians.
Primary Outcome Measure Information:
Title
Hemoglobin A1C
Description
HbA1c
Time Frame
6 months
Secondary Outcome Measure Information:
Title
HbA1c
Description
Hemoglobin A1c
Time Frame
12 months
Title
Hypoglycemia episodes
Description
Number of hypoglycemia episodes
Time Frame
6 months
Title
Adherence
Description
Adherence to Refills and Medications - Diabetes (ARMS-D)
Time Frame
6 months
Title
Diabetes self-efficacy
Description
Diabetes Self-Efficacy Scale
Time Frame
6 months
Title
PAID
Description
Problem Areas in Diabetes Scale
Time Frame
6 months
Title
Weight
Description
lbs
Time Frame
6 months
Title
Cholesterol
Description
Changes in cholesterol over time
Time Frame
6 months
Title
Blood Pressure
Description
BP
Time Frame
6 months
Title
Diabetes Quality of life
Description
Diabetes-39 is a validated instrument specifically designed to measure quality of life for diabetes patients
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renee Pekmezaris, PhD
Organizational Affiliation
Feinstein Institute for Medical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Feinstein Institute of Medical Research
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33287815
Citation
Pekmezaris R, Williams MS, Pascarelli B, Finuf KD, Harris YT, Myers AK, Taylor T, Kline M, Patel VH, Murray LM, McFarlane SI, Pappas K, Lesser ML, Makaryus AN, Martinez S, Kozikowski A, Polo J, Guzman J, Zeltser R, Marino J, Pena M, DiClemente RJ, Granville D. Adapting a home telemonitoring intervention for underserved Hispanic/Latino patients with type 2 diabetes: an acceptability and feasibility study. BMC Med Inform Decis Mak. 2020 Dec 7;20(1):324. doi: 10.1186/s12911-020-01346-0.
Results Reference
derived

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Diabetes Management Program for Hispanic/Latino

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