Diabetes Mellitus, Diabetic Foot Diabetic Foot CareNCT07452887
Education and Mobile Reminder Program for Foot Self-Care in Type 2 Diabetes
A study testing Diabetes Education and Mobile Reminder Program in people with Diabetes Mellitus, Diabetic Foot Diabetic Foot Care, run by Selma Sahin at 1 site in Turkey (Türkiye).
Trial summary
Diabetes mellitus is a metabolic disease with systemic, acute and chronic complications whose prevalence is increasing all over the world and in our country (Satman et al. 2013). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Diabetic Foot Diabetic Foot Care
- What is being tested?
- Diabetes Education and Mobile Reminder Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2026to 10 Jul 2027
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years
- Diagnosed with Type 2 Diabetes Mellitus
- Able to read and understand Turkish
- Owns a smartphone and uses WhatsApp
- Provides written informed consent
Who cannot join
- Type 1 diabetes or gestational diabetes
- Severe cognitive impairment or psychiatric disorder
- Active diabetic foot ulcer requiring hospitalization
- Participation in another structured diabetes education program within the last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University Meram Medical Faculty Hospital
Konya
About this study
Official title: The Effect of Educatıonal Program and Remınder Mobıle Applıcatıons on Foot Self-Care Behavıors, Dıabetes Management Self-Effectıveness and Qualıty of Lıfe in Type 2 Dıabetes: A Randomızed Controlled Study
Diabetes mellitus is a metabolic disease with systemic, acute and chronic complications whose prevalence is increasing all over the world and in our country (Satman et al. 2013). The prevalence of diabetes all over the world and in Turkey is increasing day by day and this situation is becoming an important public health problem (Aytemur and Vardar İnkaya 2022). Diabetic foot is an important complication that causes organ loss, affects individuals mentally, physically, socially and economically, and requires frequent hospitalization and surgical intervention (Danmusa et al. 2016, Kalaycı et al. 2020). In the prevention of diabetes, it is necessary to raise awareness and gain healthy lifestyle behaviors. This study aims to increase foot self-care behaviors, diabetes management self-efficacy and quality of life of individuals with type 2 diabetes with the education program and reminder mobile applications.
Read the detailed description
Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic disorder associated with significant morbidity and mortality, including diabetic foot complications that may lead to infection, ulceration, and amputation. Effective foot self-care behaviors are essential to prevent these complications. However, many individuals with T2DM demonstrate insufficient knowledge and adherence to recommended self-care practices.
This randomized controlled trial was designed to evaluate the effectiveness of a structured education program combined with mobile reminder messages on foot self-care behaviors, diabetes management self-efficacy, and quality of life in individuals with T2DM.
Participants were randomly assigned to either an intervention group or a control group. The intervention group received a structured diabetes foot care education program and regular reminder messages delivered through mobile communication. The control group received standard care according to routine clinical practice.
Data were collected at baseline and during follow-up assessments. The primary outcome measure was foot self-care behavior. Secondary outcomes included diabetes management self-efficacy and quality of life. Validated measurement tools were used for all assessments.
The results of this study are expected to provide evidence regarding the effectiveness of education and mobile reminder interventions in improving self-care behaviors and preventing diabetes-related foot complications.
- Being tested
- Diabetes Education and Mobile Reminder Program, Usual Care
- Keywords
- Foot Self-Care, Type 2 Diabetes Mellitus, Diabetes Education
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Education and Mobile Reminder ProgramBehavioural
Participants in the intervention group receive a structured diabetes education program focusing on foot self-care behaviors, diabetes self-management, and prevention of foot complications. The education is delivered through scheduled face-to-face training sessions supported by educational materials. In addition, participants receive regular mobile reminder messages via a mobile application designed to reinforce self-care practices, medication adherence, daily foot inspection, and lifestyle modification. The mobile reminders are delivered multiple times per week throughout the study period to enhance behavioral adherence and self-efficacy.
Usual CareBehavioural
Four-session education on diabetes and diabetic foot care, plus WhatsApp group reminders (texts/brochures/videos) and periodic private reminder messages; includes a home visit and provision of a foot-care kit; follow-up for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Education + Mobile Reminder Program | Experimental | Participants receive a structured diabetes foot self-care education program combined with scheduled mobile reminder messages or app notifications to reinforce daily foot self-care behaviors and diabetes self-management. Assessments are performed at baseline and at follow-up according to the study protocol. Receives: Behavioral: Diabetes Education and Mobile Reminder Program |
| Usual Care (Control) | Active comparator | Participants in the control group receive routine standard diabetes care provided in usual clinical practice. This includes regular medical follow-up visits, standard diabetes education delivered by healthcare professionals, and general advice on diabetes self-management and foot care as typically offered by the clinic. No additional structured education sessions, mobile reminder messages, or digital support interventions are provided during the study period. Outcome assessments are conducted at baseline, 3 months, and 6 months according to the study protocol. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Diabetes Foot Self-Care Behavior Score
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start10 Feb 2026
- Primary completion10 Apr 2027 (estimated)
- Study completion10 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Diabetic Foot Diabetic Foot CareStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selma Sahin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Selma Sahin, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452887
- Sponsor's protocol ID
- 2023/395
- Status last verified
- Feb 2026
- First submitted
- 1 Mar 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Educatıonal Program and Remınder Mobıle Applıcatıons on Foot Self-Care Behavıors, Dıabetes Management Self-Effectıveness and Qualıty of Lıfe in Type 2 Dıabetes: A Randomızed Controlled Study
- ClinicalTrials.gov ID
- NCT07452887
- Acronym / sponsor ID
- 2023/395
- Keywords
- Foot Self-Care, Type 2 Diabetes Mellitus, Diabetes Education
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Selma SahinUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 10 Apr 2027 (estimated)
- Study completion
- 10 Jul 2027 (estimated)
- First posted
- 5 Mar 2026 (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.
Diabetes mellitus is a metabolic disease with systemic, acute and chronic complications whose prevalence is increasing all over the world and in our country (Satman et al. 2013). The prevalence of diabetes all over the world and in Turkey is increasing day by day and this situation is becoming an important public health problem (Aytemur and Vardar İnkaya 2022). Diabetic foot is an important complication that causes organ loss, affects individuals mentally, physically, socially and economically, and requires frequent hospitalization and surgical intervention (Danmusa et al. 2016, Kalaycı et al. 2020). In the prevention of diabetes, it is necessary to raise awareness and gain healthy lifestyle behaviors. This study aims to increase foot self-care behaviors, diabetes management self-efficacy and quality of life of individuals with type 2 diabetes with the education program and reminder mobile applications.
Detailed description
Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic disorder associated with significant morbidity and mortality, including diabetic foot complications that may lead to infection, ulceration, and amputation. Effective foot self-care behaviors are essential to prevent these complications. However, many individuals with T2DM demonstrate insufficient knowledge and adherence to recommended self-care practices.
This randomized controlled trial was designed to evaluate the effectiveness of a structured education program combined with mobile reminder messages on foot self-care behaviors, diabetes management self-efficacy, and quality of life in individuals with T2DM.
Participants were randomly assigned to either an intervention group or a control group. The intervention group received a structured diabetes foot care education program and regular reminder messages delivered through mobile communication. The control group received standard care according to routine clinical practice.
Data were collected at baseline and during follow-up assessments. The primary outcome measure was foot self-care behavior. Secondary outcomes included diabetes management self-efficacy and quality of life. Validated measurement tools were used for all assessments.
The results of this study are expected to provide evidence regarding the effectiveness of education and mobile reminder interventions in improving self-care behaviors and preventing diabetes-related foot complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education + Mobile Reminder Program | Experimental | Behavioral: Diabetes Education and Mobile Reminder ProgramParticipants receive a structured diabetes foot self-care education program combined with scheduled mobile reminder messages or app notifications to reinforce daily foot self-care behaviors and diabetes self-management. Assessments are performed at baseline and at follow-up according to the study protocol. |
| Usual Care (Control) | Active comparator | Behavioral: Usual CareParticipants in the control group receive routine standard diabetes care provided in usual clinical practice. This includes regular medical follow-up visits, standard diabetes education delivered by healthcare professionals, and general advice on diabetes self-management and foot care as typically offered by the clinic. No additional structured education sessions, mobile reminder messages, or digital support interventions are provided during the study period. Outcome assessments are conducted at baseline, 3 months, and 6 months according to the study protocol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18-65 years
- Diagnosed with Type 2 Diabetes Mellitus
- Able to read and understand Turkish
- Owns a smartphone and uses WhatsApp
- Provides written informed consent
Key exclusion criteria (4 listed)
- Type 1 diabetes or gestational diabetes
- Severe cognitive impairment or psychiatric disorder
- Active diabetic foot ulcer requiring hospitalization
- Participation in another structured diabetes education program within the last 6 months
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 |
|---|---|---|
| Diabetes Education and Mobile Reminder ProgramParticipants in the intervention group receive a structured diabetes education program focusing on foot self-care behaviors, diabetes self-management, and prevention of foot complications. The education is delivered through scheduled face-to-face training sessions supported by educational materials. In addition, participants receive regular mobile reminder messages via a mobile application designed to reinforce self-care practices, medication adherence, daily foot inspection, and lifestyle modification. The mobile reminders are delivered multiple times per week throughout the study period to enhance behavioral adherence and self-efficacy. | Behavioural | Education + Mobile Reminder Program |
| Usual CareFour-session education on diabetes and diabetic foot care, plus WhatsApp group reminders (texts/brochures/videos) and periodic private reminder messages; includes a home visit and provision of a foot-care kit; follow-up for 6 months. | Behavioural | Usual Care (Control) |
Primary outcome
Change in Diabetes Foot Self-Care Behavior Score
Time frame: Baseline to 6 months
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 5 Mar 2026.
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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 Diabetes Education and Mobile Reminder Program in people with Diabetes Mellitus, Diabetic Foot Diabetic Foot Care, run by Selma Sahin 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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. 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?
Change in Diabetes Foot Self-Care Behavior Score (time frame: Baseline to 6 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 5 Mar 2026.