NCT04385758

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 13, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2022

Completed
Last Updated

October 7, 2022

Status Verified

October 1, 2022

Enrollment Period

1.4 years

First QC Date

May 7, 2020

Last Update Submit

October 6, 2022

Conditions

DiabetesDiabetes Mellitus

Keywords

Community paramedicineDiabetes mellitusDiabetes distress

Outcome Measures

Primary Outcomes (1)

  • Diabetes Distress (using DDS)

    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.)

    1 month

Secondary Outcomes (4)

  • Diabetes Distress (using DDS)

    4 months

  • Confidence in Diabetes Self-Management (using DSMQ)

    1 and 4 months

  • Health-Related Quality of Life (using EQ-5D)

    1 and 4 months

  • Self-Reported Hypoglycemia and Hyperglycemia

    1 and 4 months

Study Arms (1)

Diabetes-REM Program

EXPERIMENTAL
Other: Diabetes-REM Program

Interventions

Diabetes-REM ProgramOTHER

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

Diabetes-REM Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • Community Paramedics who delivered the Diabetes-REM intervention.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Juntunen MB, Liedl CP, Carlson PN, Myers LA, Stickler ZR, Ryan Schultz JA, Meilander AK, Behnken E, Lampman MA, Rogerson MC, Fischer KM, McCoy RG. Diabetes Rescue, Engagement and Management (D-REM): rationale and design of a pragmatic clinical trial of a community paramedicine programme to improve diabetes care. BMJ Open. 2022 Apr 21;12(4):e057224. doi: 10.1136/bmjopen-2021-057224.

    PMID: 35450906DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Rozalina McCoy, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 7, 2020

First Posted

May 13, 2020

Study Start

July 13, 2020

Primary Completion

November 23, 2021

Study Completion

February 10, 2022

Last Updated

October 7, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)