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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 13, 2021
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Northwell Health

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 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 : September 30, 2019
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. Hemoglobin A1C [ Time Frame: 6 months ]
    HbA1c


Secondary Outcome Measures :
  1. HbA1c [ Time Frame: 12 months ]
    Hemoglobin A1c

  2. Hypoglycemia episodes [ Time Frame: 6 months ]
    Number of hypoglycemia episodes

  3. Adherence [ Time Frame: 6 months ]
    Adherence to Refills and Medications - Diabetes (ARMS-D)

  4. Diabetes self-efficacy [ Time Frame: 6 months ]
    Diabetes Self-Efficacy Scale

  5. PAID [ Time Frame: 6 months ]
    Problem Areas in Diabetes Scale

  6. Weight [ Time Frame: 6 months ]
    lbs

  7. Cholesterol [ Time Frame: 6 months ]
    Changes in cholesterol over time

  8. Blood Pressure [ Time Frame: 6 months ]
    BP

  9. Diabetes Quality of life [ Time Frame: 6 months ]
    Diabetes-39 is a validated instrument specifically designed to measure quality of life for diabetes patients


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Diane Marbury, CRA (516) 465-2776 dmarbury@northwell.edu
Contact: Myia Williams, PhD 516-600-1485 mwilliam26@northwell.edu

Locations
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United States, New York
Feinstein Institute of Medical Research Recruiting
Manhasset, New York, United States, 11030
Contact: Renee Pekmezaris, PhD    516-600-1402    rpekmeza@northwell.edu   
Contact: Myia Williams, PhD    516-600-1485    mwilliam26@northwell.edu   
Principal Investigator: Renee Pekmezaris, PhD         
Sponsors and Collaborators
Northwell Health
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Renee Pekmezaris, PhD Feinstein Institute for Medical Research
  Study Documents (Full-Text)

Documents provided by Northwell Health:
Study Protocol and Statistical Analysis Plan  [PDF] July 13, 2020
Informed Consent Form  [PDF] April 2, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT03960424    
Other Study ID Numbers: AD-2017C3-9185
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases