Diabetes MellitusNCT06655116
Diabetic Foot Education
An observational study of Diabetes Mellitus and Diabetic Foot Disease, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
To determine the effect of foot care training given according to Interpersonal Relationship Theory on foot care behaviour and diabetic foot self-efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Diabetic Foot Disease
- What is being tested?
- Diabetic Foot Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Oct 2024to 26 Dec 2024
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Erciyes University Health Application and Research Centre
Who may be able to join
- Over 18 years of age,
- Diagnosis of Type 2 DM for at least 6 months,
- Not having received planned diabetic foot training before,
- Volunteering to participate in the study,
Who cannot join
- Neuropsychiatric drug use and disease that may affect education (Dementia- Alzheimer's and Mental Retardation etc.)
- Being visually impaired,
- Hearing impairment,
- Inability to speak Turkish,
- Presence of active diabetic foot ulcer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Patient Education on Foot Care Behaviour and Diabetic Foot Self-Efficacy in Individuals With Type II Diabetes: A Randomised Controlled Study
To determine the effect of foot care training given according to Interpersonal Relationship Theory on foot care behaviour and diabetic foot self-efficacy.
- Conditions
- Diabetes Mellitus, Diabetic Foot Disease
- Being tested
- Diabetic Foot Education
- Keywords
- Diabetic Foot, Diabetes Mellitus, Patient Education
- Medical subject headings
- Diabetes Mellitus, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetic Foot EducationBehavioural
Patients in the intervention group will be interviewed and their diabetic foot knowledge will be evaluated. During the interview, the individual's knowledge about the definition of diabetic foot, risk factors, symptoms, treatment, complications, care and prevention will be evaluated.
In order to systematically plan, implement and evaluate the training to be used in the intervention, it is aimed to implement androgogical training based on the 'Interpersonal Relations Theory'. In this context, the stages in the theory will be followed as follows.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Not described | |
| Study Grup | Not described Receives: Behavioral: Diabetic Foot Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive Information Form:
The descriptive information form, which was created by the researchers by reviewing the literature, consists of 16 items in total, including seven questions about individual characteristics (age, gender, height, weight, education level, family structure, smoking) and nine questions about the disease and diabetic foot (HbA1c value, number of years of living with diabetes, treatment(s) received, history of diabetic foot).
Measured: 2 Minutes
Diabetic Foot Self-Care Behaviour Scale
The Diabetic Outpatient Self-Care Behaviour Scale was developed by Yen-Fan Chin and Tzu-Ting Huang in 2013 (Chin \& Huang, 2013). The Turkish validity and reliability study conducted by Bakır and Samancıoğlu Bağlama was published in 2021. The scale is a five-point Likert-type scale consisting of 7 items and two sections. The first part consists of four items including practices related to examining, washing and drying the soles of the feet and toes during the week. The three items in the second section are related to the use of shoes and lotion. The lowest score that can be obtained from the first section is 4 and the highest score is 20. The lowest score that can be obtained from the second section is 3 and the highest score is 15. The questionnaire is evaluated over the total score and the score that can be obtained varies between 7-35. As the score obtained from the scale increases, self-care behaviour increases.
Measured: 5 minutes
Diabetic Foot Care Self-Efficacy Scale
The scale consisting of nine items is answered with an 11-digit visual scale ranging from 0-10. In the answers, the lowest value is expressed as 'I do not consider it sufficient at all' and the highest value is expressed as 'I consider it very sufficient'. The scale has no sub-dimensions and is evaluated on the total scale score. The lowest score that can be obtained from the scale is 0 and the highest score is 90. As the score obtained from the scale increases, the level of diabetic foot self-efficacy increases.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start26 Oct 2024 (estimated)
- Primary completion26 Nov 2024 (estimated)
- Study completion26 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal KAHRAMAN, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655116
- Sponsor's protocol ID
- 16.10.2024
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Patient Education on Foot Care Behaviour and Diabetic Foot Self-Efficacy in Individuals With Type II Diabetes: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06655116
- Acronym / sponsor ID
- 16.10.2024
- Conditions
- Diabetes Mellitus, Diabetic Foot Disease
- Keywords
- Diabetic Foot, Diabetes Mellitus, Patient Education
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 26 Oct 2024 (estimated)
- Primary completion
- 26 Nov 2024 (estimated)
- Study completion
- 26 Dec 2024 (estimated)
- First posted
- 23 Oct 2024 (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.
To determine the effect of foot care training given according to Interpersonal Relationship Theory on foot care behaviour and diabetic foot self-efficacy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | – |
| Study Grup | – | Behavioral: Diabetic Foot Education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Erciyes University Health Application and Research Centre
Key inclusion criteria (4 listed)
- Over 18 years of age,
- Diagnosis of Type 2 DM for at least 6 months,
- Not having received planned diabetic foot training before,
- Volunteering to participate in the study,
Key exclusion criteria (5 listed)
- Neuropsychiatric drug use and disease that may affect education (Dementia- Alzheimer's and Mental Retardation etc.)
- Being visually impaired,
- Hearing impairment,
- Inability to speak Turkish,
- Presence of active diabetic foot ulcer.
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 |
|---|---|---|
| Diabetic Foot EducationPatients in the intervention group will be interviewed and their diabetic foot knowledge will be evaluated. During the interview, the individual's knowledge about the definition of diabetic foot, risk factors, symptoms, treatment, complications, care and prevention will be evaluated. In order to systematically plan, implement and evaluate the training to be used in the intervention, it is aimed to implement androgogical training based on the 'Interpersonal Relations Theory'. In this context, the stages in the theory will be followed as follows. | Behavioural | Study Grup |
Primary outcome
Descriptive Information Form:
Time frame: 2 Minutes
The descriptive information form, which was created by the researchers by reviewing the literature, consists of 16 items in total, including seven questions about individual characteristics (age, gender, height, weight, education level, family structure, smoking) and nine questions about the disease and diabetic foot (HbA1c value, number of years of living with diabetes, treatment(s) received, history of diabetic foot).
Diabetic Foot Self-Care Behaviour Scale
Time frame: 5 minutes
The Diabetic Outpatient Self-Care Behaviour Scale was developed by Yen-Fan Chin and Tzu-Ting Huang in 2013 (Chin \& Huang, 2013). The Turkish validity and reliability study conducted by Bakır and Samancıoğlu Bağlama was published in 2021. The scale is a five-point Likert-type scale consisting of 7 items and two sections. The first part consists of four items including practices related to examining, washing and drying the soles of the feet and toes during the week. The three items in the second section are related to the use of shoes and lotion. The lowest score that can be obtained from the first section is 4 and the highest score is 20. The lowest score that can be obtained from the second section is 3 and the highest score is 15. The questionnaire is evaluated over the total score and the score that can be obtained varies between 7-35. As the score obtained from the scale increases, self-care behaviour increases.
Diabetic Foot Care Self-Efficacy Scale
Time frame: 5 minutes
The scale consisting of nine items is answered with an 11-digit visual scale ranging from 0-10. In the answers, the lowest value is expressed as 'I do not consider it sufficient at all' and the highest value is expressed as 'I consider it very sufficient'. The scale has no sub-dimensions and is evaluated on the total scale score. The lowest score that can be obtained from the scale is 0 and the highest score is 90. As the score obtained from the scale increases, the level of diabetic foot self-efficacy increases.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Individual participant dataSharing planned: No
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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.
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?
An observational study of Diabetes Mellitus and Diabetic Foot Disease, run by TC Erciyes 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 5 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: enrolling by invitation, as of the sponsor's last update on 23 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
Descriptive Information Form: (time frame: 2 Minutes). The study lists 3 primary outcomes in all. 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 23 Oct 2024.