Diabete Type 2NCT05904847
The Effect of Theory-Based Education on Patient Empowerment and Self-Efficacy in Patients With Type 2 Diabetes
A study testing Application of The Theory of Planned Behaviour for Diabetes in people with Diabete Type 2, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
It is essential to manage the disease to prevent and reduce complications and mortality in patients with diabetes. Adequate information and options should be provided to patients by healthcare providers so that patients can make informed choices. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabete Type 2
- What is being tested?
- Application of The Theory of Planned Behaviour for Diabetes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Apr 2023to 26 Oct 2023
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteering to participate in the study
- 40 years and older
- Diagnosed with type 2 DM at least 1 year ago
- Treated at the hospital where the study will be conducted
- Using antidiabetic agents
- No communication problem
- Contactable by phone
Who cannot join
- Those who do not meet the inclusion criteria for the study
- Participants who did not give consent at any stage of the study and left
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Education Given to Diabetes Patients According to the Planned Behavior Theory on Patient Empowerment and Self-Efficacy: A Single-Blind Randomized Controlled Trial
It is essential to manage the disease to prevent and reduce complications and mortality in patients with diabetes. Adequate information and options should be provided to patients by healthcare providers so that patients can make informed choices. Patient education is a patient empowerment process designed to enable patients to be responsible for their health. With this study, it is considered essential to educate diabetic patients according to the theory of planned behavior and to develop self-efficacy by contributing to patient empowerment in this way.
- Conditions
- Diabete Type 2
- Being tested
- Application of The Theory of Planned Behaviour for Diabetes
- Keywords
- Diabetes, Theory Of Planned Behavior, Patient Empowerment, Self-Efficacy
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of The Theory of Planned Behaviour for DiabetesBehavioural
In the study, diabetes education consisting of a total of 4 sessions structured according to the Planned Behavior Theory will be applied to the intervention group, and a standard diabetes education consisting of a single session containing information about diabetes on the website of the Ministry of Health will be applied to the control group. The training will be given face-to-face in groups of 10-15 people. After the training, the participants will be monitored for 3 months. To increase patient empowerment and self-efficacy, the intervention group will be followed up by phone calls every 15 days to increase motivation and answer questions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Application of The Theory of Planned Behaviour for Diabetes |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Empowerment Scale
The scale consists of 37 items in total. Scale is graded in a 5-point Likert type, and in total, the lowest 37 and the highest 185 points are taken. There is an opposite item in the scale. This applied to individuals over the age of 18 who receive long-term care services.
Measured: 2 weeks
Diabetes Management Self-Efficacy Scale for Patients with Type 2 Diabetes
The scale consists of 20 items in total. The scale is scored as a Likert type (1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always), and the lowest score from the scale is 20 and the highest score is 100.
Measured: 2 weeks
Secondary outcomes (1)
Blood Glucose Level
A condition in which the blood glucose level is above normal. Hyperglycemia is mentioned when fasting blood glucose exceeds 100 mg/dl and postprandial blood glucose exceeds 140 mg/dl.
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 posted15 Jun 2023
- Study start16 Apr 2023
- Primary completion17 Jun 2023
- Study completion26 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904847
- Sponsor's protocol ID
- 13353
- Status last verified
- May 2024
- First submitted
- 6 Jun 2023
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Goger S, Sener S, Ci Ngi L D. The effect of training to diabetes patients according to planned behavior theory on self-efficacy and patient empowerment: A randomized study. Prim Care Diabetes. 2024 Oct;18(5):486-492. doi: 10.1016/j.pcd.2024.08.002. Epub 2024 Aug 24.
PubMed 39183095
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Given to Diabetes Patients According to the Planned Behavior Theory on Patient Empowerment and Self-Efficacy: A Single-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05904847
- Acronym / sponsor ID
- 13353
- Conditions
- Diabete Type 2
- Keywords
- Diabetes, Theory Of Planned Behavior, Patient Empowerment, Self-Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 16 Apr 2023 (actual)
- Primary completion
- 17 Jun 2023 (actual)
- Study completion
- 26 Oct 2023 (actual)
- First posted
- 15 Jun 2023 (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 is essential to manage the disease to prevent and reduce complications and mortality in patients with diabetes. Adequate information and options should be provided to patients by healthcare providers so that patients can make informed choices. Patient education is a patient empowerment process designed to enable patients to be responsible for their health. With this study, it is considered essential to educate diabetic patients according to the theory of planned behavior and to develop self-efficacy by contributing to patient empowerment in this way.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Application of The Theory of Planned Behaviour for Diabetes |
| Control | No intervention | – |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Volunteering to participate in the study
- 40 years and older
- Diagnosed with type 2 DM at least 1 year ago
- Treated at the hospital where the study will be conducted
- Using antidiabetic agents
Key exclusion criteria (2 listed)
- Those who do not meet the inclusion criteria for the study
- Participants who did not give consent at any stage of the study and left
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 |
|---|---|---|
| Application of The Theory of Planned Behaviour for DiabetesIn the study, diabetes education consisting of a total of 4 sessions structured according to the Planned Behavior Theory will be applied to the intervention group, and a standard diabetes education consisting of a single session containing information about diabetes on the website of the Ministry of Health will be applied to the control group. The training will be given face-to-face in groups of 10-15 people. After the training, the participants will be monitored for 3 months. To increase patient empowerment and self-efficacy, the intervention group will be followed up by phone calls every 15 days to increase motivation and answer questions. | Behavioural | Intervention |
Primary outcome
Patient Empowerment Scale
Time frame: 2 weeks
The scale consists of 37 items in total. Scale is graded in a 5-point Likert type, and in total, the lowest 37 and the highest 185 points are taken. There is an opposite item in the scale. This applied to individuals over the age of 18 who receive long-term care services.
Diabetes Management Self-Efficacy Scale for Patients with Type 2 Diabetes
Time frame: 2 weeks
The scale consists of 20 items in total. The scale is scored as a Likert type (1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always), and the lowest score from the scale is 20 and the highest score is 100.
1 secondary outcome
Blood Glucose Level
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 7 May 2024.
- Derived from this study: PubMed 39183095Goger S, Sener S, Ci Ngi L D. The effect of training to diabetes patients according to planned behavior theory on self-efficacy and patient empowerment: A randomized study. Prim Care Diabetes. 2024 Oct;18(5):486-492. doi: 10.1016/j.pcd.2024.08.002. Epub 2024 Aug 24.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of The Theory of Planned Behaviour for Diabetes in people with Diabete Type 2, run by Sakarya 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 7 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 7 May 2024. 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?
Patient Empowerment Scale (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05904847, which also lists 1 linked publication.
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 7 May 2024.