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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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.
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.
Behavioral: regular health education
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 16, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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