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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04509856
Other study ID # YaseminC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date July 31, 2019

Study information

Verified date August 2020
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date July 31, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Teach-back educational method
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.

Locations

Country Name City State
Turkey Ataturk University Hospital Erzurum

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diabetes knowledge level (DKL) 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 Fasting blood glucose Fasting blood glucose in mg/dl 3 months
Secondary HbA1c HbA1c in % 3 months
Secondary Blood pressure Blood pressure in mmHG 3 months
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