NCT06516705

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 24, 2024

Completed
6 months until next milestone

Results Posted

Study results publicly available

January 30, 2025

Completed
Last Updated

January 30, 2025

Status Verified

July 1, 2024

Enrollment Period

2.1 years

First QC Date

July 9, 2024

Results QC Date

August 4, 2024

Last Update Submit

December 18, 2024

Conditions

Keywords

multimedia educationhypoglycemiaknowledgeself-care behaviorthe recurrence rate of hypoglycemic events

Outcome Measures

Primary Outcomes (5)

  • The Score of Hypoglycemia Knowledge

    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

    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

    Form Recorded for Health Education Time

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

  • The Score of Education Satisfaction

    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

    Questionnaire to assess the rate of hypoglycemic events.

    Through study completion, an average of 6 months.

Secondary Outcomes (3)

  • The Score of Fear of Hypoglycemia

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

  • The Score of Social Support

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

  • The Score of Quality of Life

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

Study Arms (2)

Multimedia hypoglycemia health education

EXPERIMENTAL

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

Conventional hypoglycemia education

ACTIVE COMPARATOR

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

Interventions

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

Conventional hypoglycemia educationMultimedia hypoglycemia health education

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Mei-Chuan Huang
Organization
National Tainan Junior College of Nursing

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participants in the experimental group receiving multimedia hypoglycemia education and participants in the contrast group receiving conventional hypoglycemia education.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2024

First Posted

July 24, 2024

Study Start

November 9, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

January 30, 2025

Results First Posted

January 30, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations