- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05658744
Video Training to Reduce Insulin Administration Errors
December 13, 2022 updated by: Gunes Feyizoglu, Goztepe Prof Dr Suleyman Yalcın City Hospital
Effect Of Reducing Insulin Implementation Errors In Education Compared To Routine Approach In Type 2 Diabetes Patients Using Insulin: A Randomized Controlled Study
Efficiency of training with video to reduce injection errors in patients using insulin
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to examine the effects of using insulin administration video and insulin administration brochure as teaching materials in insulin administration training given to type 2 diabetes patients on correcting insulin administration errors.
This randomized controlled experimental study was carried out with 94 people who applied to the diabetes outpatient clinic of Istanbul Medeniyet University Goztepe Training and Research Hospital between December 2019 and January 2021.
Using a computer-based randomization method, 52 and 42 people were assigned to the groups that received training with video and brochures, respectively.
In the first interview, patients' insulin administration characteristics were evaluated, and the training was repeated using the video or brochure, after which the training material corresponding to the group according to the randomization list was given.
Insulin administration characteristics of the patients were re-evaluated one week and three months later.
Patient information form developed by the researcher based on the literature was used to collect the data.
Data were analysed using descriptive statistics, independent sample t-test and Mann Whitney U test.
The error rates in the interviews were analysed with the Cochrane Q test, and the relationship between independent categorical variables was examined with the Chi-square test.
Study Type
Interventional
Enrollment (Actual)
94
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
İstanbul
-
Kadıköy, İstanbul, Turkey, 34722
- Goztepe Prof Dr Suleyman Yalcın City Hospital
-
-
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
Ages Eligible for Study
14 years to 96 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- mobile phone can download video
- video watching skills
Exclusion Criteria:
- illiterate patient
- new to insulin therapy
- who can't watch video on mobile phone
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Video group
Insulin administration video was shown to 52 patients with diabetes using insulin.
The video was sent to the patients' mobile phones
|
Insulin administration video was sent to the mobile phones of the patients assigned to the video group
|
|
Experimental: Brochure group
Insulin administration leaflet was given to 42 patients with diabetes using insulin.
Patients read the brochure aloud
|
Insulin administration video was sent to the mobile phones of the patients assigned to the video group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behavior change
Time Frame: 3 months later
|
Video training is effective in reducing insulin administration errors.
There was no statistically significant difference between the groups in terms of sociodemographic characteristics of the individuals in the video and brochure group (p>0.05).
The mean number of corrects in insulin administration increased from 12.94 to 20.15 in the group given the training video and from 14.33 to 18.67 in the group given the training brochure, with the patients who received video training having a higher mean number of corrects than the patients who received training with a brochure (t=2.69,
p=0.009).
In conclusion, retraining patients using insulin therapy with a video was found to be an effective approach to reduce insulin administration errors.
|
3 months later
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
December 25, 2019
Primary Completion (Actual)
June 25, 2020
Study Completion (Actual)
January 25, 2021
Study Registration Dates
First Submitted
December 3, 2022
First Submitted That Met QC Criteria
December 13, 2022
First Posted (Actual)
December 21, 2022
Study Record Updates
Last Update Posted (Actual)
December 21, 2022
Last Update Submitted That Met QC Criteria
December 13, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SuleymanYalcın
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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