Diabetes MellitusNCT03665870
Prevention Through Intervention: Telehealth Solution to Deter 911 Calls Due to Hypoglycemia
A study testing Hypoglycemia Education in people with Diabetes Mellitus and Hypoglycemia Unawareness, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Diabetes Mellitus, Hypoglycemia Unawareness, Hypoglycemia
- What is being tested?
- Hypoglycemia Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 20 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Enrolled currently in any diabetes related educational programs
Trial locations and contacts
1 site in 1 country.
United States1 site
Birmingham Fire and Rescue Service
Birmingham, Alabama, 35209
About this study
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.
- Being tested
- Hypoglycemia Education
- Keywords
- Telehealth, Emergency Medicine, Paramedicine, Diabetes, Hypoglycemia, Telecoaching
- Medical subject headings
- Diabetes Mellitus, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoglycemia EducationBehavioural
Two in-person visits to the home of the participant and 4 phone calls will be conducted to provided education on prevention of hypoglycemia.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Hypoglycemia Education: Participants will receive educational support to prevent repeat episodes of hypoglycemia. Receives: Behavioral: Hypoglycemia Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 8 weeks
Secondary outcomes (2)
Self Efficacy
Measured using the "Perceived Diabetes Self-Management Scale".
Measured: Pre and Post (after 8 weeks)Through study completion, an average of 8 weeks
Knowledge of Diabetes
Measured using the "The Knowledge in Low Literacy in Diabetes Knowledge Assessment Scale"
Measured: Through study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start1 Oct 2018
- Primary completion24 May 2020
- Study completion20 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm pre-post study.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Birmingham Fire and Rescue Service
- Responsible party
- Principal investigator, Mohanraj Thirumalai, University of Alabama at Birmingham
- Investigators
- Mohanraj Thirumalai, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665870
- Sponsor's protocol ID
- UAB-CHSP-2017-1
- Status last verified
- Jul 2020
- First submitted
- 29 Aug 2018
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34342593
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention Through Intervention: Telehealth Solution to Deter 911 Calls Due to Hypoglycemia
- ClinicalTrials.gov ID
- NCT03665870
- Acronym / sponsor ID
- UAB-CHSP-2017-1
- Keywords
- Telehealth, Emergency Medicine, Paramedicine, Diabetes, Hypoglycemia, Telecoaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Birmingham Fire and Rescue Service
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 24 May 2020 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm pre-post study.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Hypoglycemia EducationHypoglycemia Education: Participants will receive educational support to prevent repeat episodes of hypoglycemia. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Enrolled currently in any diabetes related educational programs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypoglycemia EducationTwo in-person visits to the home of the participant and 4 phone calls will be conducted to provided education on prevention of hypoglycemia. | Behavioural | Intervention Arm |
Primary outcome
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.
2 secondary outcomes
Self Efficacy
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Derived from this study: PubMed 34342593Thirumalai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohanraj Thirumalai, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoglycemia Education in people with Diabetes Mellitus and Hypoglycemia Unawareness, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of Hypoglycemia (time frame: Through study completion, an average of 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03665870, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.