- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03728647
The Effectiveness of Multimedia Education for Patients With Type 2 Diabe Mellitus
November 1, 2018 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital
Multimedia Education on Knowledge, Injection Skill, Insulin Injection Self-efficacy, Injection Performance Rate, Educational Satisfaction, Nursing Hours, and Biophysical Indicators
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To explore the effectiveness of two types health education on knowledge in diabetes and insulin injection, skills in insulin injection, self-efficacy in insulin injection, injection performance rate, satisfaction with health education,nursing hours, and biophysical indicators among the type 2 diabetes who began insulin therapy using a pen injector.With a repeated measures experimental study design, 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.
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of type 2 diabetes.
- First received insulin injection with Lantus, Levemir or Novomix.
- Ability to communicate in Mandarin or Taiwanese.
- Ability to self-inject insulin.
Exclusion Criteria:
- Cognitive impairment or dementia, inability to manage self-care.
- Severe or unstable medical conditions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: multimedia health education
The program (flat touch computer) consisted of knowledge and technology levels.
Knowledge: diabetic introduction, treatment, management of hyper- and hypoglycemia, complications, and experience sharing of insulin injection by a patient group.
Technology: steps of insulin injection skills and complete technology demonstration .
The program contents were organized using a unit-based piecemeal teaching approach.
Participants could adjust their learning pace according to individual situations and could practice injection skills using an injection mold during hospitalization.
A diabetes educator has assessed the learning outcome of each participant after intervention.
At the day of discharge from hospital, each participant would acquire a copy of the multimedia health education compact disc.
|
The program (flat touch computer) consisted of knowledge and technology levels.
Knowledge: diabetic introduction, treatment, management of hyper- and hypoglycemia, complications, and experience sharing of insulin injection by a patient group.
Technology: steps of insulin injection skills and complete technology demonstration .
The program contents were organized using a unit-based piecemeal teaching approach.
Participants could adjust their learning pace according to individual situations and could practice injection skills using an injection mold during hospitalization.
A diabetes educator has assessed the learning outcome of each participant after intervention.
At the day of discharge from hospital, each participant would acquire a copy of the multimedia health education compact disc.
|
Active Comparator: regular health education
The regular (traditional) education program (a diabetes educator) consisted of knowledge and technology levels.
Knowledge: diabetic introduction, treatment, management of hyper- and hypoglycemia, and complications.
Technology: steps of insulin injection skills and complete technology demonstration.
|
The traditional education program (a diabetes educator) consisted of knowledge and technology levels.
Knowledge: diabetic introduction, treatment, management of hyper- and hypoglycemia, and complications.
Technology: steps of insulin injection skills and complete technology demonstration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
diabetes and insulin injection related knowledge scale
Time Frame: Change from Baseline diabetes and insulin injection related knowledge to the thirteenth week after discharge from hospital
|
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
|
insulin injection skills scale
Time Frame: Change from Baseline insulin injection skills to the thirteenth week after discharge from hospital
|
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
|
self-efficacy in insulin injection scale
Time Frame: Change from Baseline self-efficacy in insulin injection to the thirteenth week after discharge from hospital
|
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
|
The health education satisfaction scale
Time Frame: Change from the day prior to discharge satisfaction with health education to the thirteenth week after discharge from hospital
|
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
|
nursing hours
Time Frame: Through intervention to the day prior to discharge from hospital, an average of 1 week
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
glycated hemoglobin(HbA1C)
Time Frame: Change from Baseline HbA1C to the thirteenth week after discharge from hospital
|
Record the concentration of HbA1C (%) from the lab data in medical record
|
Change from Baseline HbA1C to the thirteenth week after discharge from hospital
|
blood creatinine
Time Frame: Change from Baseline blood creatinine to the thirteenth week after discharge from hospital
|
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
|
insulin performance rate
Time Frame: Change from the first week after discharge insulin performance rate from hospital to the thirteenth week after discharge
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Mei-Chuan Huang, PHD, National Tainan Junior College of Nursing
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 16, 2013
Primary Completion (Actual)
August 31, 2014
Study Completion (Actual)
August 31, 2014
Study Registration Dates
First Submitted
October 28, 2018
First Submitted That Met QC Criteria
November 1, 2018
First Posted (Actual)
November 2, 2018
Study Record Updates
Last Update Posted (Actual)
November 2, 2018
Last Update Submitted That Met QC Criteria
November 1, 2018
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMUH-IRB-20130146
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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