Back to resultsThe Effectiveness of Multimedia Education for Patients With Type 2 Diabe Mellitus
Primary Purpose
Type 2 Diabetes Mellitus, Insulin, Education
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
multimedia health education
regular health education
Sponsored by
About this trial
This is an interventional supportive care trial for Type 2 Diabetes Mellitus
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
multimedia health education
regular health education
Arm Description
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 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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
glycated hemoglobin(HbA1C)
Record the concentration of HbA1C (%) from the lab data in medical record
blood creatinine
Record the concentration of blood creatinine (mg/dl) from the lab data in medical record
insulin performance rate
The rate of insulin injection at home
Full Information
NCT ID
NCT03728647
First Posted
October 28, 2018
Last Updated
November 1, 2018
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03728647
Brief Title
The Effectiveness of Multimedia Education for Patients With Type 2 Diabe Mellitus
Official Title
Multimedia Education on Knowledge, Injection Skill, Insulin Injection Self-efficacy, Injection Performance Rate, Educational Satisfaction, Nursing Hours, and Biophysical Indicators
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
August 16, 2013 (Actual)
Primary Completion Date
August 31, 2014 (Actual)
Study Completion Date
August 31, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Insulin, Education
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study used a randomized repeated-measures experimental design. The experimental group received a multimedia health education program and the control group received a regular health education program.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
multimedia health education
Arm Type
Experimental
Arm Description
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.
Arm Title
regular health education
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
multimedia health education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
regular health education
Intervention Description
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.
Primary Outcome Measure Information:
Title
diabetes and insulin injection related knowledge scale
Description
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.
Time Frame
Change from Baseline diabetes and insulin injection related knowledge to the thirteenth week after discharge from hospital
Title
insulin injection skills scale
Description
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.
Time Frame
Change from Baseline insulin injection skills to the thirteenth week after discharge from hospital
Title
self-efficacy in insulin injection scale
Description
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.
Time Frame
Change from Baseline self-efficacy in insulin injection to the thirteenth week after discharge from hospital
Title
The health education satisfaction scale
Description
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.
Time Frame
Change from the day prior to discharge satisfaction with health education to the thirteenth week after discharge from hospital
Title
nursing hours
Description
The nursing hours were calculated by adding up the total time spent by the diabetes educator instructing each participant to perform insulin injection.
Time Frame
Through intervention to the day prior to discharge from hospital, an average of 1 week
Secondary Outcome Measure Information:
Title
glycated hemoglobin(HbA1C)
Description
Record the concentration of HbA1C (%) from the lab data in medical record
Time Frame
Change from Baseline HbA1C to the thirteenth week after discharge from hospital
Title
blood creatinine
Description
Record the concentration of blood creatinine (mg/dl) from the lab data in medical record
Time Frame
Change from Baseline blood creatinine to the thirteenth week after discharge from hospital
Title
insulin performance rate
Description
The rate of insulin injection at home
Time Frame
Change from the first week after discharge insulin performance rate from hospital to the thirteenth week after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei-Chuan Huang, PHD
Organizational Affiliation
National Tainan Junior College of Nursing
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effectiveness of Multimedia Education for Patients With Type 2 Diabe Mellitus
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