The Effectiveness of Multimedia Education on Hypoglycemic Management.

December 18, 2024 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital

The Relationship Between Knowledge, Self-care Behaviors, Fear, Social Support and Quality of Life in Patients With Type 2 Diabetes, and the Effectiveness of Multimedia Education on Hypoglycemic Management.

The first phase of the research was to develop tools, including scales and multimedia, and the second phase was to carry out multimedia hypoglycemia education intervention measures. An experimental randomized controlled trial with a repeated measures design was conducted in second phase. Participants in the experimental group receiving multimedia hypoglycemia education and participants in the contrast group receiving conventional hypoglycemia education. Structural questionnaires were used for data collection. The study was to investigate the effectiveness of multimedia hypoglycemia education compared to conventional hypoglycemia education on knowledge, self-care behavior, fear of hypoglycemia, social support, quality of life, nursing hours, education satisfaction, and the recurrence rate of hypoglycemic events among patients with type 2 diabetes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In the first phase, we created multimedia educational content on hypoglycemia and recruited 300 type 2 diabetes patients who had experienced hypoglycemic events from a medical center and a primary care clinic in southern Taiwan. The participants completed consent forms and questionnaires, and we conducted statistical analyses to develop and evaluate knowledge and behavior assessment tools. We obtained consent from 83 participants to enter the second phase, where they received hypoglycemia education and were then randomly assigned by computer to either the experimental group or the contrast group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
83

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • type 2 diabetes and blood glucose levels below 70 mg/dL

Exclusion Criteria:

  • patients with cognitive impairment, those who are unable to perform activities of daily living and those with severe or unstable medical conditions.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Multimedia hypoglycemia health education
The multimedia educational content included an introduction to blood glucose, symptoms and management of hypoglycemia (the 15-rule), prevention of hypoglycemia (diet and exercise), and medication therapy.
Behavioral: Hypoglycemia education
Hypoglycemia education : incleded introduction to blood glucose, hypoglycemia symptoms and treatment (15-15 rule), prevention of hypoglycemia (diet and exercise), and medication treatment.
Active Comparator: Conventional hypoglycemia education
The verbal educational content provided by the health educators included an introduction to blood glucose, symptoms and management of hypoglycemia (the 15-rule), prevention of hypoglycemia (diet and exercise), and medication therapy.
Behavioral: Hypoglycemia education
Hypoglycemia education : incleded introduction to blood glucose, hypoglycemia symptoms and treatment (15-15 rule), prevention of hypoglycemia (diet and exercise), and medication treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Score of Hypoglycemia Knowledge
Time Frame: Through study completion, an average of 6 months after education.
Hypoglycemia management knowledge scale to collect the score in Knowledge. The scale consists of eight true/false questions, with scores ranging from 0 to 8 points. Higher scores indicate a higher level of knowledge about hypoglycemia in patients.
Through study completion, an average of 6 months after education.
The Score of Hypoglycemia Self-care Behavior
Time Frame: Through study completion, an average of 6 months after education.
Hypoglycemia self-care behavior scale to collect the score in Behavior. The scale comprises 10 items, each rated on a 5-point Likert scale, with total scores ranging from 10 to 50. Higher scores indicate better self-care behaviors in managing hypoglycemia.
Through study completion, an average of 6 months after education.
Nursing Time
Time Frame: Through study completion, an average of 6 months after education.
Form Recorded for Health Education Time
Through study completion, an average of 6 months after education.
The Score of Education Satisfaction
Time Frame: Through study completion, an average of 6 months after education.
Education satisfaction scale to collect the score in education satisfaction. Items were rated on a 5-point Likert scale, with a score range of 1 to 5 points, for a total score range of 5 to 25 points.
Through study completion, an average of 6 months after education.
The Recurrence Rate of Hypoglycemic Events
Time Frame: Through study completion, an average of 6 months.
Questionnaire to assess the rate of hypoglycemic events.
Through study completion, an average of 6 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Score of Fear of Hypoglycemia
Time Frame: Through study completion, an average of 6 months after education.
Hypoglycemia fear scale to collect the score in fear of hypoglycemia. This scale consists of 13 items, rated on a 5-point Likert scale with a score range of 0 to 52 points. Higher scores indicate a greater degree of fear of hypoglycemia among patients.
Through study completion, an average of 6 months after education.
The Score of Social Support
Time Frame: Through study completion, an average of 6 months after education.
Social support scale to collect the score in social support. The scale consists of 13 items, rated on a 5-point Likert scale with a score range of 0 to 52 points. Higher scores indicate higher levels of social support.
Through study completion, an average of 6 months after education.
The Score of Quality of Life
Time Frame: Through study completion, an average of 6 months after education.
Quality of life scale to collect the score in quality of life. The scale consists of 28 items, each rated on a 5-point Likert scale, with scores for each domain converted to a total range of 16 to 80 points.
Through study completion, an average of 6 months after education.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaohsiung Medical University Chung-Ho Memorial Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KMUHIRB-E(II)-20180100

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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