NCT04509856

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 7, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

August 7, 2020

Last Update Submit

August 10, 2020

Conditions

Keywords

diabeteseducationteach-back

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Fasting blood glucose

    3 months

  • HbA1c

    3 months

  • Blood pressure

    3 months

Study Arms (2)

Control Group

NO INTERVENTION

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.

Intervention Group

EXPERIMENTAL

Intervention Group will take their diabetes education by teach-back educational strategy.

Behavioral: Teach-back educational method

Interventions

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.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with a diagnosis of dementia
  • To have vision or hearing loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University Hospital

Erzurum, 25040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patient ParticipationDiabetes Mellitus

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Yasemin Cayir, 1

    Ataturk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 7, 2020

First Posted

August 12, 2020

Study Start

April 1, 2019

Primary Completion

June 30, 2019

Study Completion

July 31, 2019

Last Updated

August 12, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

The clinical outcomes will be shared.

Locations