Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effectiveness of Multimedia Education for Patients With Type 2 Diabe Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03728647
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Insulin Education Behavioral: multimedia health education Behavioral: regular health education Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Multimedia Education on Knowledge, Injection Skill, Insulin Injection Self-efficacy, Injection Performance Rate, Educational Satisfaction, Nursing Hours, and Biophysical Indicators
Actual Study Start Date : August 16, 2013
Actual Primary Completion Date : August 31, 2014
Actual Study Completion Date : August 31, 2014

Resource links provided by the National Library of Medicine


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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728647


Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
Layout table for investigator information
Study Director: Mei-Chuan Huang, PHD National Tainan Junior College of Nursing
Layout table for additonal information
Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT03728647    
Other Study ID Numbers: KMUH-IRB-20130146
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: August 2013
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases