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

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Diabetes
• Interventions: Other: Diabetes-REM Program

• Registration Number: NCT04385758
• Lead Sponsor: 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-09
• Study First Posted: 2020-05-13
• Study Start: 2020-07-13
• Primary Completion: 2021-11-23
• Study Completion: 2022-02-10
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-06
• Last Update Posted: 2022-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diabetes-REM Program	Diabetes-REM Program	-

Primary Outcome Measures

Name	Time	Method
Diabetes Distress (using DDS)	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

Name	Time	Method
Health-Related Quality of Life (using EQ-5D)	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)
Diabetes Distress (using DDS)	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.)
Self-Reported Hypoglycemia and Hyperglycemia	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
Confidence in Diabetes Self-Management (using DSMQ)	1 and 4 months	The level of confidence patient participants express in managing their diabetes using the Diabetes Self-Management Questionnaire (DSMQ)

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States