NCT07808255

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
2mo left

Started Oct 2026

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Oct 2026Dec 2026

First Submitted

Initial submission to the registry

August 27, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 8, 2026

Status Verified

August 1, 2026

Enrollment Period

1 month

First QC Date

August 27, 2026

Last Update Submit

September 6, 2026

Conditions

Diabetes MellitusNursing CareSelf-care

Keywords

Individualized Nursing CareDiabetes MellitusRandomized Controlled TrialEmpowermentSelf-Efficacy

Outcome Measures

Primary Outcomes (3)

  • 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).

    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).

    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).

    Baseline and 3 months

Study Arms (2)

Intervention Group (Arm 1)

EXPERIMENTAL

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

Behavioral: Individualized Nursing Care

Control Group (Arm 2)

NO INTERVENTION

Participants receiving standard routine clinical care.

Interventions

Individualized Nursing CareBEHAVIORAL

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.

Intervention Group (Arm 1)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yalova Training and Research Hospital

Yalova, Turkey (Türkiye)

Location

Related Publications (7)

  • Yavuz Erener, K. (2019). Yetişkin diyabet bilgi ölçeği'nin (YDBÖ) geliştirilmesi; geçerlik ve güvenirlik çalışması. Yüksek Lisans Tezi, Marmara Üniversitesi Sağlık Bilimleri Enstitüsü.

    BACKGROUND

  • Özcan, H. (2012). Diyabet güçlendirme ölçeğinin Türk toplumu için geçerlik güvenirliğinin incelenmesi (Master's thesis, Sağlık Bilimleri Enstitüsü).

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • Canbolat, Ö., Ekenler, Ş., & Polat, Ü. (2022). Diyabet Özyönetiminde Engeller Ve Kolaylaştırıcılar. SDÜ Tıp Fakültesi Dergisi, 29(1), 143-148.

    BACKGROUND

  • 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.

    PMID: 10840988BACKGROUND

  • 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.

    PMID: 33426121BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusEmpowerment

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSocial BehaviorBehavior

Central Study Contacts

Şeyda Can, associate professor

CONTACT

+905366850312seyda.can@yalova.edu.tr

Emel Avçin, Assistant Professor

CONTACT

+905534524243leylifer02@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants are blinded to their group assignment (or outcome assessors are blinded to group allocations to prevent bias during data collection and evaluation).
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 27, 2026

First Posted

September 8, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 8, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, ICF
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.

Locations

TU(1)