Diabetes MellitusINDIS-DMNCT07808255
Effect of Individualized Nursing Care on Diabetes Self-Management
A study testing Individualized Nursing Care in people with Diabetes Mellitus and Nursing Care, run by University of Yalova at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effects of individualized nursing care interventions on self-efficacy, empowerment, and self-management behaviors in individuals diagnosed with diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Nursing Care, Self-care
- What is being tested?
- Individualized Nursing Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 1 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with diabetes (Type 1 or Type 2)
- Age 18 years or older
- Able to communicate in Turkish and cooperate with the study requirements
- Voluntarily willing to participate and sign the informed consent form
Who cannot join
- Having severe cognitive impairment, psychiatric disorders, or communication barriers that prevent participation
- Having severe terminal illnesses or acute medical complications that interfere with follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Yalova Training and Research Hospital
Yalova
Şeyda Assoc. Prof. Dr. Şeyda Can, Assoc. Prof., seyda.can@yalova.edu.tr
About this study
Official title: The Effect of Individualized Nursing Care Interventions on Self-Efficacy and Empowerment in Individuals With Diabetes: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effects of individualized nursing care interventions on self-efficacy, empowerment, and self-management behaviors in individuals diagnosed with diabetes. Diabetes requires lifelong management, and standard care approaches often fall short of meeting individual psychosocial and clinical needs. By implementing structured, patient-centered nursing care protocols, this study assesses how personalized education, follow-up, and support mechanisms influence patients' capacity to manage their condition, improve glycemic control, and enhance their overall quality of life.
Read the detailed description
Diabetes mellitus is a chronic metabolic condition that demands continuous daily self-care, dietary adherence, medication management, and regular monitoring to prevent long-term complications. Traditional clinical approaches are frequently standardized, which can limit their effectiveness in addressing the unique psychosocial, behavioral, and cultural needs of individual patients.
- Conditions
- Diabetes Mellitus, Nursing Care, Self-care
- Being tested
- Individualized Nursing Care
- Keywords
- Individualized Nursing Care, Diabetes Mellitus, Randomized Controlled Trial, Empowerment, Self-Efficacy
- Medical subject headings
- Diabetes Mellitus, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Nursing CareBehavioural
Participants in this group receive structured, personalized nursing care sessions, including targeted education, individual goal-setting, self-monitoring guidance, and ongoing follow-up to enhance diabetes self-management.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Arm 1) | Experimental | Participants receiving structured, individualized nursing care interventions and support protocols. Receives: Behavioral: Individualized Nursing Care |
| Control Group (Arm 2) | No intervention | Participants receiving standard routine clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adult Diabetes Knowledge Score
Change in adult diabetes knowledge score as measured by the Adult Diabetes Knowledge Scale (ADKS) from baseline to 3 months. (Total score ranging from 0 to 28 points).
Measured: Baseline and 3 months
Diabetes Self-Management Behaviors Score
Change in diabetes self-management score as measured by the Diabetes Self-Management Questionnaire (DSMQ) from baseline to 3 months. (Total and subscale points).
Measured: Baseline and 3 months
Diabetes Empowerment and Psychosocial Self-Efficacy Score
Change in diabetes empowerment score as measured by the Diabetes Empowerment Scale (DES) from baseline to 3 months. (Likert scale points ranging from 0 to 5).
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are allocated into two parallel groups (intervention group receiving individualized nursing care and control group receiving routine standard care) with a 1:1 allocation ratio.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Yalova
- Sponsor type
- University, hospital or other
- Collaborators
- Yalova Training and Research Hospital
- Responsible party
- Principal investigator, Seyda Can, University of Yalova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808255
- Sponsor's protocol ID
- 2024/172
- Acronym
- INDIS-DM
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes, de-identified participant data will be shared upon reasonable request to the corresponding author.
Publications
Yavuz Erener, K. (2019). Yetişkin diyabet bilgi ölçeği'nin (YDBÖ) geliştirilmesi; geçerlik ve güvenirlik çalışması. Yüksek Lisans Tezi, Marmara Üniversitesi Sağlık Bilimleri Enstitüsü.
Özcan, H. (2012). Diyabet güçlendirme ölçeğinin Türk toplumu için geçerlik güvenirliğinin incelenmesi (Master's thesis, Sağlık Bilimleri Enstitüsü).
Kılınç, E., & Kartal, A. (2021). Tip 2 Diyabet Yönetiminde Bilgi-Motivasyon ve Davranış Becerileri (IMB) Modelinin Kullanımı. Ordu Üniversitesi Hemşirelik Çalışmaları Dergisi, 4(3), 408-417.
Eroğlu, N., & Sabuncu, N. (2019). Diyabet Öz Yönetim Skalası'nın (DÖYS) Türk Toplumuna Uyarlanması: Geçerlik ve Güvenirlik Çalışması. Hemşirelik Bilimi Dergisi, 1(3), 1-6.
Canbolat, Ö., Ekenler, Ş., & Polat, Ü. (2022). Diyabet Özyönetiminde Engeller Ve Kolaylaştırıcılar. SDÜ Tıp Fakültesi Dergisi, 29(1), 143-148.
Anderson RM, Funnell MM, Fitzgerald JT, Marrero DG. The Diabetes Empowerment Scale: a measure of psychosocial self-efficacy. Diabetes Care. 2000 Jun;23(6):739-43. doi: 10.2337/diacare.23.6.739.
PubMed 10840988Ameri M, Movahed E, Farokhzadian J. Effect of information, motivation, and behavioral skills model on adherence to medication, diet, and physical activity in HIV/ADIS patients: A health promotion strategy. J Educ Health Promot. 2020 Nov 26;9:317. doi: 10.4103/jehp.jehp_188_20. eCollection 2020.
PubMed 33426121
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Individualized Nursing Care Interventions on Self-Efficacy and Empowerment in Individuals With Diabetes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07808255
- Acronym / sponsor ID
- INDIS-DM / 2024/172
- Conditions
- Diabetes Mellitus, Nursing Care, Self-care
- Keywords
- Individualized Nursing Care, Diabetes Mellitus, Randomized Controlled Trial, Empowerment, Self-Efficacy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of YalovaUniversity, hospital or other
- Collaborators
- Yalova Training and Research Hospital
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 8 Sep 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.
This randomized controlled trial aims to evaluate the effects of individualized nursing care interventions on self-efficacy, empowerment, and self-management behaviors in individuals diagnosed with diabetes. Diabetes requires lifelong management, and standard care approaches often fall short of meeting individual psychosocial and clinical needs. By implementing structured, patient-centered nursing care protocols, this study assesses how personalized education, follow-up, and support mechanisms influence patients' capacity to manage their condition, improve glycemic control, and enhance their overall quality of life.
Detailed description
Diabetes mellitus is a chronic metabolic condition that demands continuous daily self-care, dietary adherence, medication management, and regular monitoring to prevent long-term complications. Traditional clinical approaches are frequently standardized, which can limit their effectiveness in addressing the unique psychosocial, behavioral, and cultural needs of individual patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are allocated into two parallel groups (intervention group receiving individualized nursing care and control group receiving routine standard care) with a 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Arm 1) | Experimental | Behavioral: Individualized Nursing CareParticipants receiving structured, individualized nursing care interventions and support protocols. |
| Control Group (Arm 2) | No intervention | –Participants receiving standard routine clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with diabetes (Type 1 or Type 2)
- Age 18 years or older
- Able to communicate in Turkish and cooperate with the study requirements
- Voluntarily willing to participate and sign the informed consent form
Key exclusion criteria (2 listed)
- Having severe cognitive impairment, psychiatric disorders, or communication barriers that prevent participation
- Having severe terminal illnesses or acute medical complications that interfere with follow-up
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 |
|---|---|---|
| Individualized Nursing CareParticipants in this group receive structured, personalized nursing care sessions, including targeted education, individual goal-setting, self-monitoring guidance, and ongoing follow-up to enhance diabetes self-management. | Behavioural | Intervention Group (Arm 1) |
Primary outcome
Adult Diabetes Knowledge Score
Time frame: Baseline and 3 months
Change in adult diabetes knowledge score as measured by the Adult Diabetes Knowledge Scale (ADKS) from baseline to 3 months. (Total score ranging from 0 to 28 points).
Diabetes Self-Management Behaviors Score
Time frame: Baseline and 3 months
Change in diabetes self-management score as measured by the Diabetes Self-Management Questionnaire (DSMQ) from baseline to 3 months. (Total and subscale points).
Diabetes Empowerment and Psychosocial Self-Efficacy Score
Time frame: Baseline and 3 months
Change in diabetes empowerment score as measured by the Diabetes Empowerment Scale (DES) from baseline to 3 months. (Likert scale points ranging from 0 to 5).
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 8 Sep 2026.
- BackgroundYavuz Erener, K. (2019). Yetişkin diyabet bilgi ölçeği'nin (YDBÖ) geliştirilmesi; geçerlik ve güvenirlik çalışması. Yüksek Lisans Tezi, Marmara Üniversitesi Sağlık Bilimleri Enstitüsü.
- BackgroundÖzcan, H. (2012). Diyabet güçlendirme ölçeğinin Türk toplumu için geçerlik güvenirliğinin incelenmesi (Master's thesis, Sağlık Bilimleri Enstitüsü).
- BackgroundKılınç, E., & Kartal, A. (2021). Tip 2 Diyabet Yönetiminde Bilgi-Motivasyon ve Davranış Becerileri (IMB) Modelinin Kullanımı. Ordu Üniversitesi Hemşirelik Çalışmaları Dergisi, 4(3), 408-417.
- BackgroundEroğlu, N., & Sabuncu, N. (2019). Diyabet Öz Yönetim Skalası'nın (DÖYS) Türk Toplumuna Uyarlanması: Geçerlik ve Güvenirlik Çalışması. Hemşirelik Bilimi Dergisi, 1(3), 1-6.
- BackgroundCanbolat, Ö., Ekenler, Ş., & Polat, Ü. (2022). Diyabet Özyönetiminde Engeller Ve Kolaylaştırıcılar. SDÜ Tıp Fakültesi Dergisi, 29(1), 143-148.
- Background: PubMed 10840988Anderson RM, Funnell MM, Fitzgerald JT, Marrero DG. The Diabetes Empowerment Scale: a measure of psychosocial self-efficacy. Diabetes Care. 2000 Jun;23(6):739-43. doi: 10.2337/diacare.23.6.739.
- Background: PubMed 33426121Ameri M, Movahed E, Farokhzadian J. Effect of information, motivation, and behavioral skills model on adherence to medication, diet, and physical activity in HIV/ADIS patients: A health promotion strategy. J Educ Health Promot. 2020 Nov 26;9:317. doi: 10.4103/jehp.jehp_188_20. eCollection 2020.
- Individual participant dataSharing planned: Yes. Yes, de-identified participant data will be shared upon reasonable request to the corresponding author.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Nursing Care in people with Diabetes Mellitus and Nursing Care, run by University of Yalova 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: opening soon, as of the sponsor's last update on 8 Sep 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?
Contact Şeyda Can, associate professor (+905366850312, seyda.can@yalova.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adult Diabetes Knowledge Score (time frame: Baseline and 3 months). 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?
On the ClinicalTrials.gov record for NCT07808255, which also lists 7 linked publications.
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 8 Sep 2026.