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Completed

NCT Number: NCT04385758

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

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 Southeast Minnesota (Mower, Freeborn, and Olmsted counties) and Northwest Wisconsin (Barron, Rusk, and Dunn) who have uncontrolled diabetes (HbA1c ≥ 9%) and have experienced an emergency department (ED) visit or hospitalization for any cause in the prior 6 months.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 Mayo Clinic Health System practice.
  • Able to provide informed consent.
  • Proficient in English.
  • Community-dwelling.
  • Live in Southeast Minnesota (Mower, Freeborn, or Olmsted counties) or Northwest Wisconsin (Barron, Rusk, or Dunn 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.

Treatment and study plan

Diabetes-REM Program

Other

A comprehensive community paramedicine management program designed to support adults with uncontrolled diabetes and a recent emergency department visit or hospitalization

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
May 13, 2020
Registry last updated
Oct 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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