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NCT Number: NCT07808255

Effect of Individualized Nursing Care on Diabetes Self-Management

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yalova Training and Research Hospital

Yalova, Turkey (Türkiye)

Location contact

Şeyda Assoc. Prof. Dr. Şeyda Can, Assoc. Prof.

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 informed consent form

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

Treatment and study plan

Individualized Nursing Care

Behavioral

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Emel Avçin, Assistant Professor

CONTACT

[email protected]

+905534524243

Şeyda Can, associate professor

CONTACT

[email protected]

+905366850312

Sponsors and collaborators

Lead sponsor

University of Yalova

Other

Collaborators

  • Yalova training and research hospital

Registry information

Official study title

The Effect of Individualized Nursing Care Interventions on Self-Efficacy and Empowerment in Individuals With Diabetes: A Randomized Controlled Trial

Acronym: INDIS-DM

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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