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Not yet recruitingNCT07808255INDIS-DMUpdated Sep 8, 2026

Effect of Individualized Nursing Care on Diabetes Self-Management

An interventional study of Individualized Nursing Care in Diabetes Mellitus, Nursing Care and Self-care, sponsored by University of Yalova. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by University of Yalova · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Diabetes Mellitus
  • Nursing Care
  • Self-care

Keywords

  • Individualized Nursing Care
  • Diabetes Mellitus
  • Randomized Controlled Trial
  • Empowerment
  • Self-Efficacy
03

In context

Diabetes Mellitus

8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.

This study's planned enrollment of 68 is below the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

University of Yalova is the lead sponsor of 61 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 form

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
68 participants (estimated)

Study arms

  • Experimental
    Intervention Group (Arm 1)

    Participants receiving structured, individualized nursing care interventions and support protocols.

    Behavioral: Individualized Nursing Care

  • No intervention
    Control Group (Arm 2)

    Participants receiving standard routine clinical care.

Interventions

  • BehavioralIndividualized Nursing Care

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline and 3 months

  2. 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).

    Time frame: Baseline and 3 months

  3. 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).

    Time frame: Baseline and 3 months

07

Study locations

1 site
08

References and documents

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 10840988 ↗
  • Ameri 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 ↗

Individual participant data

Plan to share: Yes — Yes, de-identified participant data will be shared upon reasonable request to the corresponding author.

Supporting information: Study protocol, Informed consent form

Time frame: Available beginning 3 months following article publication and ending 5 years after publication.

Access criteria: Requests should be directed to the corresponding author via email. Access will be granted to researchers whose proposed use of the data has been approved by an independent review committee for individual participant meta-analyses.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07808255
Lead sponsor
University of Yalova
Collaborators
Yalova training and research hospital
Responsible party
Seyda Can (Associate Professor, University of Yalova) — Principal investigator
First posted
Sep 8, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Nov 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Sep 8, 2026

Study contacts

Şeyda Can, associate professor
Contact
seyda.can@yalova.edu.tr
+905366850312
Emel Avçin, Assistant Professor
Contact
leylifer02@gmail.com
+905534524243

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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