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NCT03960424 Clinical Trial

Diabetes Management Program for Hispanic/Latino

Type 2 Diabetes Clinical Trial

Official title:
Diabetes Management Program for Hispanic/Latino

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03960424
Other study ID # 19-0002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 30, 2019
Est. completion date September 8, 2023

Study information
Verified date October 2023
Source Northwell Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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 information / eligibility
Status Completed
Enrollment 240
Est. completion date September 8, 2023
Est. primary completion date March 12, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Comprehensive Outpatient Management
Patients receiving comprehensive outpatient management experience typical care received in the outpatient setting.
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.

Locations
Country Name City State
United States Feinstein Institute of Medical Research Manhasset New York

Sponsors (2)
Lead Sponsor Collaborator
Northwell Health Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hemoglobin A1C HbA1c 6 months
Secondary HbA1c Hemoglobin A1c 12 months
Secondary Hypoglycemia episodes Number of hypoglycemia episodes 6 months
Secondary Adherence Adherence to Refills and Medications - Diabetes (ARMS-D) 6 months
Secondary Diabetes self-efficacy Diabetes Self-Efficacy Scale 6 months
Secondary PAID Problem Areas in Diabetes Scale 6 months
Secondary Weight lbs 6 months
Secondary Cholesterol Changes in cholesterol over time 6 months
Secondary Blood Pressure BP 6 months
Secondary Diabetes Quality of life Diabetes-39 is a validated instrument specifically designed to measure quality of life for diabetes patients 6 months
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