NCT06717256

Brief Summary

This research will be conducted in a pre-test-post-test randomized controlled, single-blind experimental design to evaluate the effects of a nurse coaching program on self-management and skin care behaviors in patients with diabetes. The key question(s) it aims to answer are:

  • Does the nurse coaching program have no effect on self-management behaviors and skin care behaviors in patients with diabetes?
  • Does the nurse coaching program have no effect on self-management behaviors and skin care behaviors in patients with diabetes?

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

December 20, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

1 month

First QC Date

December 1, 2024

Last Update Submit

December 4, 2024

Conditions

Keywords

Diabetes Mellitus Self Management EducationSkin CareTip II Diyabet Mellitus

Outcome Measures

Primary Outcomes (1)

  • PERSONAL INFORMATION FORM

    A two-part personal information form prepared by the researcher based on the literature (Herath et al. 2017; Kassahun et al. 2017; Ahmed et al. 2019; ADA 2021; Alaofè et al. 2021) was used. The Personal Information Form consists of 7 questions about socio-demographic characteristics (age, gender, marital status, educational status, presence of health insurance, economic status, place of residence) and 7 questions about disease-health characteristics (blood sugar measurement status, ability to take medications regularly, presence of any chronic disease other than diabetes, status of consulting a doctor for diabetes control, exercise status, status of receiving sufficient education regarding diabetes, if the answer is yes, what trainings have been received, measured HbA1C result).

    Before the study.

Secondary Outcomes (1)

  • Diabetes Self Management Questionnaire

    Before application, at week 6 of application and at week 12 of application

Other Outcomes (1)

  • Skin Care Behavior Monitoring Form

    before application, at week 6 of application and at week 12 of application

Study Arms (2)

EDUCATION GROUP

EXPERIMENTAL

In addition to routine training provided by physicians to patients in this group, training will be provided within the first 6 weeks, where "the effect of the nurse coaching program on self-management and skin care behaviors in diabetic patients will be evaluated" and monthly reminders will be provided thereafter. The content of the training booklet prepared for self-management and skin care will be presented to the participants as a face-to-face training in the form of one-week presentations to be completed in 6 weeks, in the form of oral presentations. At the end of the module training, participants will be asked questions and answered. Six weeks after the training is completed, participants will be provided with reminders, and the trainings they want to be repeated will be repeated.

Behavioral: training

CONTROL GROUP

NO INTERVENTION

Participants assigned to the control group will receive information training as part of their check-ups, as in routine practice; however, the intervention program evaluating the effect of the nurse coaching program on self-management and skin care behaviors in diabetic patients will not be implemented.

Interventions

trainingBEHAVIORAL

The diabetes education booklet is a collection of information designed by the researcher. These interventions will continue for 1.5 months, with a total of 6 sessions for each type 2 DM individual, lasting approximately 120 minutes (2 hours per week and 12 hours in total after 6 weeks), and will be carried out as reminders afterwards. In these sessions, agendas will be created appropriately on regular eating habits, physical activity, regular monitoring of blood sugar, compliance with treatment, problem-solving ability, coping strategies and minimizing risks, conflicts regarding self-management and skin care behaviors of the patient will be tried to be resolved, the patient's suitability and adaptation to the change phase will be determined, their willingness to change will be questioned, and the change plan will be helped in the matters of care and self-management.

Also known as: scin care, self-management
EDUCATION GROUP

Eligibility Criteria

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

You may qualify if:

  • Being between the ages of 18-65,
  • Having a Type 2 DM diagnosis period of 6 months or more,
  • Not having any psychiatric disorders or mental problems,
  • Having hemoglobin A1c values \<8 mmol/mL,
  • Individuals who can perform diabetes self-management behaviors and skin care behaviors (regular eating habits, physical activity, regular monitoring of blood sugar, compliance with treatment, ability to solve problems, coping strategies and minimizing risks).

You may not qualify if:

  • Having verbal communication problems,
  • Having been diagnosed with Type 1 Diabetes Mellitus,
  • Having been diagnosed with gestational diabetes mellitus,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

RehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

BURCU KÜÇÇÜK, MSC

CONTACT

DİLEK CİNGİL, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

December 1, 2024

First Posted

December 4, 2024

Study Start

December 20, 2024

Primary Completion

January 20, 2025

Study Completion

June 20, 2025

Last Updated

December 9, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share