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Community Paramedicine Program to Improve Diabetes Care Quality, Equity, and Outcomes in Southeast Minnesota

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04385758
Recruitment Status : Not yet recruiting
First Posted : May 13, 2020
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Rozalina G. McCoy, Mayo Clinic

Brief Summary:
The purpose of this study is evaluate the effectiveness of Diabetes-REM (Rescue, Engagement, and Management), a comprehensive community paramedic (CP) program to support adults in rural Minnesota (Mower and Freeborn counties) who have uncontrolled diabetes (HbA1c ≥ 9%) and have experienced an emergency department (ED) visit or hospitalization for any cause in the prior 6 months.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus Other: Diabetes-REM Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Community Paramedicine Program to Improve Diabetes Care Quality, Equity, and Outcomes in Southeast Minnesota
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2022

Arm Intervention/treatment
Experimental: Diabetes-REM Program Other: Diabetes-REM Program
A comprehensive community paramedicine management program designed to support adults with uncontrolled diabetes and a recent emergency department visit or hospitalization




Primary Outcome Measures :
  1. Diabetes Distress (using DDS) [ Time Frame: 1 month ]
    The level of diabetes-related distress that is expressed by patient participants using the Diabetes Distress Scale (the DDS contains 17 questions, with responses ranging from "Not a Problem" (1) to "A Very Serious Problem" (6). Total scores use the sum of all responses divided by 17, with a mean item score of 3 or higher (moderate distress) indicating distress worthy of clinical attention.)


Secondary Outcome Measures :
  1. Diabetes Distress (using DDS) [ Time Frame: 4 months ]
    The level of diabetes-related distress that is expressed by patient participants using the Diabetes Distress Scale (the DDS contains 17 questions, with responses ranging from "Not a Problem" (1) to "A Very Serious Problem" (6). Total scores use the sum of all responses divided by 17, with a mean item score of 3 or higher (moderate distress) indicating distress worthy of clinical attention.)

  2. Confidence in Diabetes Self-Management (using DSMQ) [ Time Frame: 1 and 4 months ]
    The level of confidence patient participants express in managing their diabetes using the Diabetes Self-Management Questionnaire (DSMQ)

  3. Health-Related Quality of Life (using EQ-5D) [ Time Frame: 1 and 4 months ]
    Patients participants' self-reported health-related quality of life using the EuroQol 5-D (also known as EQ-5D; an instrument for measuring quality of life)

  4. Self-Reported Hypoglycemia and Hyperglycemia [ Time Frame: 1 and 4 months ]
    Incidences of hypoglycemia (blood glucose <70 mg/dL and <54 mg/dL) and hyperglycemia (blood glucose ≥250 mg/dL) as reported by patient participants



Information from the National Library of Medicine

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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 (Patients):

  • Most recent hemoglobin A1c ≥ 9% within the last 2 years.
  • Age ≥ 18 years old.
  • Type 1 or type 2 diabetes.
  • Paneled to a Mayo Clinic or MCHS practice.
  • Able to provide informed consent.
  • Proficient in English.
  • Community-dwelling.
  • Live in Mower or Freeborn counties.

Inclusion Criteria (Paramedics):

•Community Paramedics who delivered the Diabetes-REM intervention.

Exclusion Criteria:

  • Cognitive impairment precluding informed consent.
  • Lack of conversational English skills.
  • Resident of a long-term care facility.
  • Enrolled in hospice.
  • Enrolled in a care coordination or disease management program.
  • Advanced or terminal illness.

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): NCT04385758


Contacts
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Contact: Rozalina McCoy, MD 507-538-7955 McCoy.Rozalina@mayo.edu

Sponsors and Collaborators
Mayo Clinic
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Responsible Party: Rozalina G. McCoy, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04385758    
Other Study ID Numbers: 20-001011
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
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
Keywords provided by Rozalina G. McCoy, Mayo Clinic:
Community paramedicine
Diabetes mellitus
Diabetes distress
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases