Back to resultsPrevention Through Intervention: Telehealth Solution to Deter 911 Calls Due to Hypoglycemia
Primary Purpose
Diabetes Mellitus, Hypoglycemia Unawareness, Hypoglycemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hypoglycemia Education
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes Mellitus focused on measuring Telehealth, Emergency Medicine, Paramedicine, Diabetes, Hypoglycemia, Telecoaching
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
a) Enrolled currently in any diabetes related educational programs
Sites / Locations
- Birmingham Fire and Rescue Service
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention Arm
Arm Description
Hypoglycemia Education: Participants will receive educational support to prevent repeat episodes of hypoglycemia.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Self Efficacy
Measured using the "Perceived Diabetes Self-Management Scale".
Knowledge of Diabetes
Measured using the "The Knowledge in Low Literacy in Diabetes Knowledge Assessment Scale"
Full Information
NCT ID
NCT03665870
First Posted
August 29, 2018
Last Updated
July 21, 2020
Sponsor
University of Alabama at Birmingham
Collaborators
Birmingham Fire and Rescue Service
1. Study Identification
Unique Protocol Identification Number
NCT03665870
Brief Title
Prevention Through Intervention: Telehealth Solution to Deter 911 Calls Due to Hypoglycemia
Official Title
Prevention Through Intervention: Telehealth Solution to Deter 911 Calls Due to Hypoglycemia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
May 24, 2020 (Actual)
Study Completion Date
July 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Birmingham Fire and Rescue Service
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Hypoglycemia Unawareness, Hypoglycemia, Hypoglycemia Acute
Keywords
Telehealth, Emergency Medicine, Paramedicine, Diabetes, Hypoglycemia, Telecoaching
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm pre-post study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Hypoglycemia Education: Participants will receive educational support to prevent repeat episodes of hypoglycemia.
Intervention Type
Behavioral
Intervention Name(s)
Hypoglycemia Education
Intervention Description
Two in-person visits to the home of the participant and 4 phone calls will be conducted to provided education on prevention of hypoglycemia.
Primary Outcome Measure Information:
Title
Fear of Hypoglycemia
Description
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.
Time Frame
Through study completion, an average of 8 weeks
Secondary Outcome Measure Information:
Title
Self Efficacy
Description
Measured using the "Perceived Diabetes Self-Management Scale".
Time Frame
Pre and Post (after 8 weeks)Through study completion, an average of 8 weeks
Title
Knowledge of Diabetes
Description
Measured using the "The Knowledge in Low Literacy in Diabetes Knowledge Assessment Scale"
Time Frame
Through study completion, an average of 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
a) Enrolled currently in any diabetes related educational programs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohanraj Thirumalai, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Birmingham Fire and Rescue Service
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34342593
Citation
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.
Results Reference
derived
Learn more about this trial
Prevention Through Intervention: Telehealth Solution to Deter 911 Calls Due to Hypoglycemia
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