Hypoglycemia, Type2diabetes
Conditions
Keywords
multimedia education, hypoglycemia, knowledge, self-care behavior, the recurrence rate of hypoglycemic events
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.
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.
Interventions
BEHAVIORALHypoglycemia education
Hypoglycemia education : incleded introduction to blood glucose, hypoglycemia symptoms and treatment (15-15 rule), prevention of hypoglycemia (diet and exercise), and medication treatment.
Sponsors
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Intervention model description
Participants in the experimental group receiving multimedia hypoglycemia education and participants in the contrast group receiving conventional hypoglycemia education.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Recurrence Rate of Hypoglycemic Events | Through study completion, an average of 6 months. | Questionnaire to assess the rate of hypoglycemic events. |
| The Score of Hypoglycemia Self-care Behavior | 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. |
| Nursing Time | Through study completion, an average of 6 months after education. | Form Recorded for Health Education Time |
| The Score of Education Satisfaction | 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. |
| The Score of Hypoglycemia Knowledge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Score of Social Support | 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. |
| The Score of Quality of Life | 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. |
| The Score of Fear of Hypoglycemia | 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. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 41 |
| 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.
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. | 41 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| T1( Before Hypoglycemia Education) | Withdrawal by Subject | 1 | 0 |
| T3 ( 3 Month After Education) | covid-19 | 1 | 2 |
| T3 ( 3 Month After Education) | No follow-up clinic visits | 3 | 3 |
| T3 ( 3 Month After Education) | Refused to respond | 0 | 1 |
| T4 ( 6 Month After Education) | covid-19 | 3 | 2 |
| T4 ( 6 Month After Education) | No follow-up clinic visits | 3 | 3 |
| T4 ( 6 Month After Education) | Refused to respond | 0 | 1 |
Baseline characteristics
| Characteristic | Conventional Hypoglycemia Education | Total | Multimedia Hypoglycemia Health Education |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 32 Participants | 62 Participants | 30 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 20 Participants | 11 Participants |
| Age, Continuous | 69.7 years STANDARD_DEVIATION 5.6 | 69.9 years STANDARD_DEVIATION 6.4 | 70.0 years STANDARD_DEVIATION 7.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 41 Participants | 82 Participants | 41 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Taiwan | 41 Participants | 82 Participants | 41 Participants |
| Sex: Female, Male Female | 21 Participants | 37 Participants | 16 Participants |
| Sex: Female, Male Male | 20 Participants | 45 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 41 |
| other Total, other adverse events | 0 / 41 | 0 / 41 |
| serious Total, serious adverse events | 0 / 41 | 0 / 41 |
Outcome results
Primary
Nursing Time
Form Recorded for Health Education Time
Time frame: Through study completion, an average of 6 months after education.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Multimedia Hypoglycemia Health Education | Nursing Time | 9.4 minute | Standard Deviation 2.4 |
| Conventional Hypoglycemia Education | Nursing Time | 14.8 minute | Standard Deviation 7 |
Primary
The Recurrence Rate of Hypoglycemic Events
Questionnaire to assess the rate of hypoglycemic events.
Time frame: Through study completion, an average of 6 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Multimedia Hypoglycemia Health Education | The Recurrence Rate of Hypoglycemic Events | 16 Participants |
| Conventional Hypoglycemia Education | The Recurrence Rate of Hypoglycemic Events | 19 Participants |
Primary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Multimedia Hypoglycemia Health Education | The Score of Education Satisfaction | 22.6 score on a scale | Standard Deviation 4.5 |
| Conventional Hypoglycemia Education | The Score of Education Satisfaction | 17.1 score on a scale | Standard Deviation 4.3 |
Primary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Multimedia Hypoglycemia Health Education | The Score of Hypoglycemia Knowledge | 5.8 score on a scale | Standard Error 0.2 |
| Conventional Hypoglycemia Education | The Score of Hypoglycemia Knowledge | 4.8 score on a scale | Standard Error 0.2 |
Primary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Multimedia Hypoglycemia Health Education | The Score of Hypoglycemia Self-care Behavior | 31.2 score on a scale | Standard Error 0.8 |
| Conventional Hypoglycemia Education | The Score of Hypoglycemia Self-care Behavior | 28.6 score on a scale | Standard Error 0.9 |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Multimedia Hypoglycemia Health Education | The Score of Fear of Hypoglycemia | 7.0 score on a scale | Standard Error 0.8 |
| Conventional Hypoglycemia Education | The Score of Fear of Hypoglycemia | 5.1 score on a scale | Standard Error 0.7 |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Multimedia Hypoglycemia Health Education | The Score of Quality of Life | 52.3 score on a scale | Standard Error 0.8 |
| Conventional Hypoglycemia Education | The Score of Quality of Life | 51.5 score on a scale | Standard Error 0.8 |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Multimedia Hypoglycemia Health Education | The Score of Social Support | 23.0 score on a scale | Standard Error 1.6 |
| Conventional Hypoglycemia Education | The Score of Social Support | 21.8 score on a scale | Standard Error 1.4 |