Patient EmpowermentNCT04509856
Teach-Back Educational Method On Diabetes Knowledge Level
A study testing Teach-back educational method in people with Patient Empowerment, run by Ataturk University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Empowerment
- What is being tested?
- Teach-back educational method
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with a diagnosis of dementia
- To have vision or hearing loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Patient Empowerment
- Being tested
- Teach-back educational method
- Keywords
- diabetes, education, teach-back
- Medical subject headings
- Patient Participation, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teach-back educational methodBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Teach-back educational method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
Fasting blood glucose
Fasting blood glucose in mg/dl
Measured: 3 months
HbA1c
HbA1c in %
Measured: 3 months
Blood pressure
Blood pressure in mmHG
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start1 Apr 2019
- Primary completion30 Jun 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient EmpowermentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Cayir, Ataturk University
- Investigators
- Yasemin Cayir, 1, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509856
- Sponsor's protocol ID
- YaseminC
- Status last verified
- Aug 2020
- First submitted
- 7 Aug 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The clinical outcomes will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact Of Teach-Back Educational Method On Diabetes Knowledge Level And Clinical Parameters In Type 2 Diabetes Patients Undergoing Insulin Therapy
- ClinicalTrials.gov ID
- NCT04509856
- Acronym / sponsor ID
- YaseminC
- Conditions
- Patient Empowerment
- Keywords
- diabetes, education, teach-back
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Teach-back educational methodIntervention Group will take their diabetes education by teach-back educational strategy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with a diagnosis of dementia
- To have vision or hearing loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teach-back educational methodIn 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. | Behavioural | Intervention Group |
Primary outcome
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 secondary outcomes
Fasting blood glucose
Time frame: 3 months
HbA1c
Time frame: 3 months
Blood pressure
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Individual participant dataSharing planned: No. The clinical outcomes will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasemin Cayir, 1 principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teach-back educational method in people with Patient Empowerment, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes knowledge level (DKL) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.