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

Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03728647
Collaborator
(none)
72
2
12.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: multimedia health education
  • Behavioral: regular health education
N/A

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

Study Type:
Interventional
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.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 :
Aug 16, 2013
Actual Primary Completion Date :
Aug 31, 2014
Actual Study Completion Date :
Aug 31, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. diabetes and insulin injection related knowledge scale [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 [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 [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 [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 [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) [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

  • Study Director: Mei-Chuan Huang, PHD, National Tainan Junior College of Nursing

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT03728647
Other Study ID Numbers:
  • KMUH-IRB-20130146
First Posted:
Nov 2, 2018
Last Update Posted:
Nov 2, 2018
Last Verified:
Aug 1, 2013
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 2, 2018