An interventional study of Hypoglycemia education in Type2diabetes and Hypoglycemia, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Completed at 1 site in Taiwan. Per ClinicalTrials.gov, last updated 2025-01-30.
Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Not applicable, Interventional, and Health services research
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.
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 83 is close to the median of 80 across 7,523 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 281 studies on the registry; 57 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
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.
Time frame: 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.
Time frame: Through study completion, an average of 6 months after education.
Nursing Time
Form Recorded for Health Education Time
Time frame: 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.
Time frame: Through study completion, an average of 6 months after education.
The Recurrence Rate of Hypoglycemic Events
Questionnaire to assess the rate of hypoglycemic events.
Time frame: Through study completion, an average of 6 months.
The Score of Fear of Hypoglycemia
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.
Time frame: Through study completion, an average of 6 months after education.
The Score of Social Support
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.
Time frame: Through study completion, an average of 6 months after education.
The Score of Quality of Life
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.
Time frame: Through study completion, an average of 6 months after education.
| Milestone | Multimedia Hypoglycemia Health Education | Conventional Hypoglycemia Education |
|---|---|---|
| Started | 42 | 41 |
| Completed | 41 | 41 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Milestone | Multimedia Hypoglycemia Health Education | Conventional Hypoglycemia Education |
|---|---|---|
| Started | 41 | 41 |
| Completed | 41 | 41 |
| Not completed | 0 | 0 |
| Milestone | Multimedia Hypoglycemia Health Education | Conventional Hypoglycemia Education |
|---|---|---|
| Started | 41 | 41 |
| Completed | 37 | 35 |
| Not completed | 4 | 6 |
| Withdrew: No follow-up clinic visits | 3 | 3 |
| Withdrew: Covid-19 | 1 | 2 |
| Withdrew: Refused to respond | 0 | 1 |
| Milestone | Multimedia Hypoglycemia Health Education | Conventional Hypoglycemia Education |
|---|---|---|
| Started | 41 | 41 |
| Completed | 35 | 35 |
| Not completed | 6 | 6 |
| Withdrew: No follow-up clinic visits | 3 | 3 |
| Withdrew: Covid-19 | 3 | 2 |
| Withdrew: Refused to respond | 0 | 1 |
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.
| score on a scale | Multimedia Hypoglycemia Health Education | Conventional Hypoglycemia Education |
|---|---|---|
| The Score of Hypoglycemia Knowledge | 5.8 ± 0.2 | 4.8 ± 0.2 |
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.
| score on a scale | Multimedia Hypoglycemia Health Education | Conventional Hypoglycemia Education |
|---|---|---|
| The Score of Hypoglycemia Self-care Behavior | 31.2 ± 0.8 | 28.6 ± 0.9 |
Form Recorded for Health Education Time
| minute | Multimedia Hypoglycemia Health Education | Conventional Hypoglycemia Education |
|---|---|---|
| Nursing Time | 9.4 ± 2.4 | 14.8 ± 7.0 |
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.
| score on a scale | Multimedia Hypoglycemia Health Education | Conventional Hypoglycemia Education |
|---|---|---|
| The Score of Education Satisfaction | 22.6 ± 4.5 | 17.1 ± 4.3 |
Questionnaire to assess the rate of hypoglycemic events.
| Participants | Multimedia Hypoglycemia Health Education | Conventional Hypoglycemia Education |
|---|---|---|
| The Recurrence Rate of Hypoglycemic Events | 16 | 19 |
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.
| score on a scale | Multimedia Hypoglycemia Health Education | Conventional Hypoglycemia Education |
|---|---|---|
| The Score of Fear of Hypoglycemia | 7.0 ± 0.8 | 5.1 ± 0.7 |
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.
| score on a scale | Multimedia Hypoglycemia Health Education | Conventional Hypoglycemia Education |
|---|---|---|
| The Score of Social Support | 23.0 ± 1.6 | 21.8 ± 1.4 |
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.
| score on a scale | Multimedia Hypoglycemia Health Education | Conventional Hypoglycemia Education |
|---|---|---|
| The Score of Quality of Life | 52.3 ± 0.8 | 51.5 ± 0.8 |
Collected over The time before education, the time after education, 3 month after education and 6 month after education.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Multimedia Hypoglycemia Health Education | 0/41 (0%) | 0/41 (0%) | 0/41 (0%) |
| Conventional Hypoglycemia Education | 0/41 (0%) | 0/41 (0%) | 0/41 (0%) |
| Age, Categorical(Participants) | Multimedia Hypoglycemia Health Education | Conventional Hypoglycemia Education | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 11 | 9 | 20 |
| >=65 years | 30 | 32 | 62 |
| Age, Continuous(years) | Multimedia Hypoglycemia Health Education | Conventional Hypoglycemia Education | Total |
|---|---|---|---|
| Mean | 70.0 ± 7.2 | 69.7 ± 5.6 | 69.9 ± 6.4 |
| Sex: Female, Male(Participants) | Multimedia Hypoglycemia Health Education | Conventional Hypoglycemia Education | Total |
|---|---|---|---|
| Female | 16 | 21 | 37 |
| Male | 25 | 20 | 45 |
| Race (NIH/OMB)(Participants) | Multimedia Hypoglycemia Health Education | Conventional Hypoglycemia Education | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 41 | 41 | 82 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Multimedia Hypoglycemia Health Education | Conventional Hypoglycemia Education | Total |
|---|---|---|---|
| Taiwan | 41 | 41 | 82 |
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Kaohsiung Medical University Chung-Ho Memorial Hospital