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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03665870
Recruitment Status : Completed
First Posted : September 11, 2018
Last Update Posted : July 22, 2020
Sponsor:
Collaborator:
Birmingham Fire and Rescue Service
Information provided by (Responsible Party):
Mohanraj Thirumalai, University of Alabama at Birmingham

Study Description
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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
Diabetes Mellitus Hypoglycemia Unawareness Hypoglycemia Hypoglycemia Acute Behavioral: Hypoglycemia Education Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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 : October 1, 2018
Actual Primary Completion Date : May 24, 2020
Actual Study Completion Date : July 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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".

  2. 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"


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665870


Locations
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United States, Alabama
Birmingham Fire and Rescue Service
Birmingham, Alabama, United States, 35209
Sponsors and Collaborators
University of Alabama at Birmingham
Birmingham Fire and Rescue Service
Investigators
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Principal Investigator: Mohanraj Thirumalai, PhD University of Alabama at Birmingham
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: September 11, 2018    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohanraj Thirumalai, University of Alabama at Birmingham:
Telehealth
Emergency Medicine
Paramedicine
 Diabetes
Hypoglycemia
Telecoaching
Additional relevant MeSH terms:
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Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases