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

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Completed
CT.gov ID
NCT03665870
Collaborator
Birmingham Fire and Rescue Service (Other)
50
Enrollment
1
Location
1
Arm
21.6
Actual Duration (Months)
2.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Hypoglycemia Education
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single arm pre-post study.Single arm pre-post study.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Prevention Through Intervention: Telehealth Solution to Deter 911 Calls Due to Hypoglycemia
Actual Study Start Date :
Oct 1, 2018
Actual Primary Completion Date :
May 24, 2020
Actual Study Completion Date :
Jul 20, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Fear of Hypoglycemia [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.

Secondary Outcome Measures

  1. Self Efficacy [Pre and Post (after 8 weeks)Through study completion, an average of 8 weeks]

    Measured using the "Perceived Diabetes Self-Management Scale".

  2. Knowledge of Diabetes [Through study completion, an average of 8 weeks]

    Measured using the "The Knowledge in Low Literacy in Diabetes Knowledge Assessment Scale"

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:
  1. Enrolled currently in any diabetes related educational programs

Contacts and Locations

Locations

Site City State Country Postal Code
1 Birmingham Fire and Rescue Service Birmingham Alabama United States 35209

Sponsors and Collaborators

  • University of Alabama at Birmingham
  • Birmingham Fire and Rescue Service

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohanraj Thirumalai, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT03665870
Other Study ID Numbers:
  • UAB-CHSP-2017-1
First Posted:
Sep 11, 2018
Last Update Posted:
Jul 22, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mohanraj Thirumalai, Assistant Professor, University of Alabama at Birmingham
Telehealth
Emergency Medicine
Paramedicine
Diabetes
Hypoglycemia
Telecoaching
Additional relevant MeSH terms:
Hypoglycemia

Study Results

No Results Posted as of Jul 22, 2020