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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04385758
Enrollment
86
Registered
2020-05-13
Start date
2020-07-13
Completion date
2022-02-10
Last updated
2022-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus

Keywords

Community paramedicine, Diabetes mellitus, Diabetes distress

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 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.

Interventions

OTHERDiabetes-REM Program

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

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Diabetes Distress (using DDS)1 monthThe 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

MeasureTime frameDescription
Diabetes Distress (using DDS)4 monthsThe 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.)
Confidence in Diabetes Self-Management (using DSMQ)1 and 4 monthsThe level of confidence patient participants express in managing their diabetes using the Diabetes Self-Management Questionnaire (DSMQ)
Health-Related Quality of Life (using EQ-5D)1 and 4 monthsPatients 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)
Self-Reported Hypoglycemia and Hyperglycemia1 and 4 monthsIncidences of hypoglycemia (blood glucose \<70 mg/dL and \<54 mg/dL) and hyperglycemia (blood glucose ≥250 mg/dL) as reported by patient participants

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026