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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03728647
Other study ID # KMUH-IRB-20130146
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 16, 2013
Est. completion date August 31, 2014

Study information

Verified date August 2013
Source Kaohsiung Medical University Chung-Ho Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date August 31, 2014
Est. primary completion date August 31, 2014
Accepts healthy volunteers No
Gender All
Age group 30 Years to 85 Years
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from Baseline diabetes and insulin injection related knowledge to the thirteenth week after discharge from hospital
Primary 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. Change from Baseline insulin injection skills to the thirteenth week after discharge from hospital
Primary 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. Change from Baseline self-efficacy in insulin injection to the thirteenth week after discharge from hospital
Primary 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. Change from the day prior to discharge satisfaction with health education to the thirteenth week after discharge from hospital
Primary 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. Through intervention to the day prior to discharge from hospital, an average of 1 week
Secondary glycated hemoglobin(HbA1C) Record the concentration of HbA1C (%) from the lab data in medical record Change from Baseline HbA1C to the thirteenth week after discharge from hospital
Secondary blood creatinine 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
Secondary insulin performance rate 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
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