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Completed

NCT Number: NCT06516705

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.

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Key information

Conditions

Type2diabetes Glucose Metabolism Disorders Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hypoglycemia education

Behavioral

Hypoglycemia education : incleded introduction to blood glucose, hypoglycemia symptoms and treatment (15-15 rule), prevention of hypoglycemia (diet and exercise), and medication treatment.

Primary outcomes

  1. 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.

  2. 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.

  3. Nursing Time

    Time frame: Through study completion, an average of 6 months after education.

    Form Recorded for Health Education Time

  4. 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.

  5. The Recurrence Rate of Hypoglycemic Events

    Time frame: Through study completion, an average of 6 months.

    Questionnaire to assess the rate of hypoglycemic events.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

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.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 24, 2024
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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