Type 2 Diabetes MellitusNCT03728647
The Effectiveness of Multimedia Education for Patients With Type 2 Diabe Mellitus
A study testing multimedia health education and regular health education in people with Type 2 Diabetes Mellitus and Insulin, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Insulin, Education
- What is being tested?
- multimedia health education and regular health education
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 16 Aug 2013to 31 Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Cognitive impairment or dementia, inability to manage self-care.
- Severe or unstable medical conditions.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus, Insulin, Education
- Being tested
- multimedia health education, regular health education
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimedia health educationBehavioural
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.
regular health educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| multimedia health education | Experimental | 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. Receives: Behavioral: multimedia health education |
| regular health education | Active comparator | 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. Receives: Behavioral: regular health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline diabetes and insulin injection related knowledge to the thirteenth week after discharge from hospital
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.
Measured: Change from Baseline insulin injection skills to the thirteenth week after discharge from hospital
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.
Measured: Change from Baseline self-efficacy in insulin injection to the thirteenth week after discharge from hospital
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.
Measured: Change from the day prior to discharge satisfaction with health education to the thirteenth week after discharge from hospital
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.
Measured: Through intervention to the day prior to discharge from hospital, an average of 1 week
Secondary outcomes (3)
glycated hemoglobin(HbA1C)
Record the concentration of HbA1C (%) from the lab data in medical record
Measured: Change from Baseline HbA1C to the thirteenth week after discharge from hospital
blood creatinine
Record the concentration of blood creatinine (mg/dl) from the lab data in medical record
Measured: Change from Baseline blood creatinine to the thirteenth week after discharge from hospital
insulin performance rate
The rate of insulin injection at home
Measured: Change from the first week after discharge insulin performance rate from hospital to the thirteenth week after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start16 Aug 2013
- Primary completion31 Aug 2014
- Study completion31 Aug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mei-Chuan Huang, PHD, Study director, National Tainan Junior College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728647
- Sponsor's protocol ID
- KMUH-IRB-20130146
- Status last verified
- Aug 2013
- First submitted
- 28 Oct 2018
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimedia Education on Knowledge, Injection Skill, Insulin Injection Self-efficacy, Injection Performance Rate, Educational Satisfaction, Nursing Hours, and Biophysical Indicators
- ClinicalTrials.gov ID
- NCT03728647
- Acronym / sponsor ID
- KMUH-IRB-20130146
- Conditions
- Type 2 Diabetes Mellitus, Insulin, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 16 Aug 2013 (actual)
- Primary completion
- 31 Aug 2014 (actual)
- Study completion
- 31 Aug 2014 (actual)
- First posted
- 2 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| multimedia health education | Experimental | Behavioral: multimedia health educationThe 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. |
| regular health education | Active comparator | Behavioral: regular health educationThe 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. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Cognitive impairment or dementia, inability to manage self-care.
- Severe or unstable medical conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multimedia health educationThe 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. | Behavioural | multimedia health education |
| regular health educationThe 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. | Behavioural | regular health education |
Primary outcome
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.
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.
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.
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.
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.
3 secondary outcomes
glycated hemoglobin(HbA1C)
Time frame: 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
insulin performance rate
Time frame: Change from the first week after discharge insulin performance rate from hospital to the thirteenth week after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei-Chuan Huang, PHD study director
National Tainan Junior College of Nursing
Questions about this trial
What is this clinical trial studying?
A study testing multimedia health education and regular health education in people with Type 2 Diabetes Mellitus and Insulin, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2018.