Prevention Through Intervention: Telehealth Solution to Deter 911 Calls Due to Hypoglycemia

July 21, 2020 updated by: Mohanraj Thirumalai, University of Alabama at Birmingham
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Birmingham Fire and Rescue Service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

a) Enrolled currently in any diabetes related educational programs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
Hypoglycemia Education: Participants will receive educational support to prevent repeat episodes of hypoglycemia.
Behavioral: Hypoglycemia Education
Two in-person visits to the home of the participant and 4 phone calls will be conducted to provided education on prevention of hypoglycemia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fear of Hypoglycemia
Time Frame: Through study completion, an average of 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self Efficacy
Time Frame: Pre and Post (after 8 weeks)Through study completion, an average of 8 weeks
Measured using the "Perceived Diabetes Self-Management Scale".
Pre and Post (after 8 weeks)Through study completion, an average of 8 weeks
Knowledge of Diabetes
Time Frame: Through study completion, an average of 8 weeks
Measured using the "The Knowledge in Low Literacy in Diabetes Knowledge Assessment Scale"
Through study completion, an average of 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Birmingham Fire and Rescue Service

Investigators

  • Principal Investigator: Mohanraj Thirumalai, PhD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

May 24, 2020

Study Completion (Actual)

July 20, 2020

Study Registration Dates

First Submitted

August 29, 2018

First Submitted That Met QC Criteria

September 7, 2018

First Posted (Actual)

September 11, 2018

Study Record Updates

Last Update Posted (Actual)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAB-CHSP-2017-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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