Type 2 Diabetes Mellitus Clinical Trial
Official title:
Multimedia Education on Knowledge, Injection Skill, Insulin Injection Self-efficacy, Injection Performance Rate, Educational Satisfaction, Nursing Hours, and Biophysical Indicators
Verified date | August 2013 |
Source | Kaohsiung Medical University Chung-Ho Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A total of 72 type 2 diabetes who began insulin therapy using a pen injector participated in this study. The experimental (n = 36) and control (n = 36) groups received multimedia and regular health education program. Four structured questionnaires were used, and videotapes were applied to demonstrate injection skills.
Status | Completed |
Enrollment | 72 |
Est. completion date | August 31, 2014 |
Est. primary completion date | August 31, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 85 Years |
Eligibility |
Inclusion Criteria: 1. Diagnosis of type 2 diabetes. 2. First received insulin injection with Lantus, Levemir or Novomix. 3. Ability to communicate in Mandarin or Taiwanese. 4. Ability to self-inject insulin. Exclusion Criteria: 1. Cognitive impairment or dementia, inability to manage self-care. 2. Severe or unstable medical conditions. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Kaohsiung Medical University Chung-Ho Memorial Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | diabetes and insulin injection related knowledge scale | The 20-item diabetes and insulin injection related knowledge scale consists of 4 domains: brief introduction to diabetes, precautions for diabetes medications and insulin injection, management of hyper- and hypoglycemia, and complications of diabetes. Total scores ranged from 0 to 20. Higher scores represent a better outcome. | Change from Baseline diabetes and insulin injection related knowledge to the thirteenth week after discharge from hospital | |
Primary | insulin injection skills scale | The insulin injection skills scale was rated by a certified diabetes educator according to each participant's performance on the 12 steps of operating a prefilled pen injector (12 items; scores ranged from 0 to 12) and the 10 steps of operating a disposable pen injector (10 items; scores ranged from 0 to 10 ). Participants scored 1 point for each correct operation and 0 points for each incorrect operation. Higher scores represent a better outcome. | Change from Baseline insulin injection skills to the thirteenth week after discharge from hospital | |
Primary | self-efficacy in insulin injection scale | The 10-item self-efficacy in insulin injection scale was modified based on the General Self-Efficacy Scale. Total scores ranged from 10 to 50. Higher scores represent a better outcome. | Change from Baseline self-efficacy in insulin injection to the thirteenth week after discharge from hospital | |
Primary | The health education satisfaction scale | The 10 items health education satisfaction scale consisted of 10 items, with total scores ranging from 10 to 50. Higher scores represent a better outcome. | Change from the day prior to discharge satisfaction with health education to the thirteenth week after discharge from hospital | |
Primary | nursing hours | The nursing hours were calculated by adding up the total time spent by the diabetes educator instructing each participant to perform insulin injection. | Through intervention to the day prior to discharge from hospital, an average of 1 week | |
Secondary | glycated hemoglobin(HbA1C) | Record the concentration of HbA1C (%) from the lab data in medical record | Change from Baseline HbA1C to the thirteenth week after discharge from hospital | |
Secondary | blood creatinine | Record the concentration of blood creatinine (mg/dl) from the lab data in medical record | Change from Baseline blood creatinine to the thirteenth week after discharge from hospital | |
Secondary | insulin performance rate | The rate of insulin injection at home | Change from the first week after discharge insulin performance rate from hospital to the thirteenth week after discharge |
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