NCT03665870

Brief Summary

This study aims to standardize and evaluate the benefits of the Prevention to Intervention program offered by the Birmingham Fire and Rescue Service. This will accomplished by standardizing the educational materials used, offering phone based follow-up and pre-post data collection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable diabetes-mellitus

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

August 29, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2020

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

1.6 years

First QC Date

August 29, 2018

Last Update Submit

July 21, 2020

Conditions

Keywords

TelehealthEmergency MedicineParamedicineDiabetesHypoglycemiaTelecoaching

Outcome Measures

Primary Outcomes (1)

  • Fear of Hypoglycemia

    One of the most important impact of hypoglycemia, is non-compliance to diabetes treatment due to the fear of hypoglycemia. This would be measured using the "Hypoglycemia Scale: FH-15" scale.

    Through study completion, an average of 8 weeks

Secondary Outcomes (2)

  • Self Efficacy

    Pre and Post (after 8 weeks)Through study completion, an average of 8 weeks

  • Knowledge of Diabetes

    Through study completion, an average of 8 weeks

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Hypoglycemia Education: Participants will receive educational support to prevent repeat episodes of hypoglycemia.

Behavioral: Hypoglycemia Education

Interventions

Two in-person visits to the home of the participant and 4 phone calls will be conducted to provided education on prevention of hypoglycemia.

Intervention Arm

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Be a citizen of Birmingham
  • Be 18 years or older
  • Receive Dextrose-50 IV (intravenous treatment provided by EMS personnel for hypoglycemia)
  • Understand and speak English

You may not qualify if:

  • a) Enrolled currently in any diabetes related educational programs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Birmingham Fire and Rescue Service

Birmingham, Alabama, 35209, United States

Location

Related Publications (1)

  • Thirumalai M, Zengul AG, Evans E. Challenges and Lessons Learned From a Telehealth Community Paramedicine Program for the Prevention of Hypoglycemia: Pre-Post Pilot Feasibility Study. JMIR Diabetes. 2021 Aug 3;6(3):e26941. doi: 10.2196/26941.

MeSH Terms

Conditions

Diabetes MellitusHypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Mohanraj Thirumalai, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Single arm pre-post study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 29, 2018

First Posted

September 11, 2018

Study Start

October 1, 2018

Primary Completion

May 24, 2020

Study Completion

July 20, 2020

Last Updated

July 22, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations