- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04509856
Teach-Back Educational Method On Diabetes Knowledge Level
August 10, 2020 updated by: Yasemin Cayir, Ataturk University
The Impact Of Teach-Back Educational Method On Diabetes Knowledge Level And Clinical Parameters In Type 2 Diabetes Patients Undergoing Insulin Therapy
It was aimed to research the effect of teach-back educational method on diabetes knowledge level and clinical parameters in type 2 diabetes patients undergoing insulin therapy.
This is a randomized-controlled trial.
Teach-back method will used for intervention group, routin diabetes education will used for control group.
The primary outcome is diabetes knowledge levels (DKL), and secondary outcome is clinical patameters (fasting blood glucose, HbA1c, blood pressure).
DKL and clinical parameters will measured and compared between two groups before and three months after the interventions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
130
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
-
-
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Erzurum, Turkey, 25040
- Ataturk University Hospital
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- To have Type 2 Diabetes
- To be over 18 years old
- Not have any barriers in understanding and speaking Turkish
- Who started insulin treatment for the first time
Exclusion Criteria:
- Patients with a diagnosis of dementia
- To have vision or hearing loss
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
Routine diabetes education will given to the patients included in the Control Group by a diabetes education nurse.
The diabetes education nurse has been working for 10 years in the same center.
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|
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Experimental: Intervention Group
Intervention Group will take their diabetes education by teach-back educational strategy.
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In the teach-back method, after teaching new information to the patient, the patients were asked to explain that new information in their own words.
Then the patients' knowledge and the adequateness of their explanations were determined.
The patient should repeat the instructions in their own words.
In this way, the healthcare professional can evaluate how the patient understands the information.
If the patient repeated the information correctly, the teach-back phase for that information was completed, and progression for new information was resumed.
However, if there was a deficiency or error in the information, it was corrected and repeated by the healthcare professional.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diabetes knowledge level (DKL)
Time Frame: 3 months
|
The DKL will be measured through a self-structured questionnaire containing 11 items.
The questionnaire contains three answers: "yes," "no," or "I do not know."
The right answer will be accepted as two points, the wrong answer as zero points, and the "I do not know" answer will be accepted as one point.
The total scores ranges from 0-22.
Higher scores of the questionnaire indicates that the higher DKL.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fasting blood glucose
Time Frame: 3 months
|
Fasting blood glucose in mg/dl
|
3 months
|
|
HbA1c
Time Frame: 3 months
|
HbA1c in %
|
3 months
|
|
Blood pressure
Time Frame: 3 months
|
Blood pressure in mmHG
|
3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yasemin Cayir, 1, Ataturk University
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)
April 1, 2019
Primary Completion (Actual)
June 30, 2019
Study Completion (Actual)
July 31, 2019
Study Registration Dates
First Submitted
August 7, 2020
First Submitted That Met QC Criteria
August 10, 2020
First Posted (Actual)
August 12, 2020
Study Record Updates
Last Update Posted (Actual)
August 12, 2020
Last Update Submitted That Met QC Criteria
August 10, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- YaseminC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
The clinical outcomes will be shared.
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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