NCT07452887

Brief Summary

Diabetes mellitus is a metabolic disease with systemic, acute and chronic complications whose prevalence is increasing all over the world and in our country (Satman et al. 2013). The prevalence of diabetes all over the world and in Turkey is increasing day by day and this situation is becoming an important public health problem (Aytemur and Vardar İnkaya 2022). Diabetic foot is an important complication that causes organ loss, affects individuals mentally, physically, socially and economically, and requires frequent hospitalization and surgical intervention (Danmusa et al. 2016, Kalaycı et al. 2020). In the prevention of diabetes, it is necessary to raise awareness and gain healthy lifestyle behaviors. This study aims to increase foot self-care behaviors, diabetes management self-efficacy and quality of life of individuals with type 2 diabetes with the education program and reminder mobile applications.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
active not 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 Progress35%
Feb 2026Jul 2027

Study Start

First participant enrolled

February 10, 2026

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2027

Last Updated

March 5, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

March 1, 2026

Last Update Submit

March 1, 2026

Conditions

Keywords

Foot Self-CareType 2 Diabetes MellitusDiabetes Education

Outcome Measures

Primary Outcomes (1)

  • Change in Diabetes Foot Self-Care Behavior Score

    Baseline to 6 months

Study Arms (2)

Education + Mobile Reminder Program

EXPERIMENTAL

Participants receive a structured diabetes foot self-care education program combined with scheduled mobile reminder messages or app notifications to reinforce daily foot self-care behaviors and diabetes self-management. Assessments are performed at baseline and at follow-up according to the study protocol.

Behavioral: Diabetes Education and Mobile Reminder Program

Usual Care (Control)

ACTIVE COMPARATOR

Participants in the control group receive routine standard diabetes care provided in usual clinical practice. This includes regular medical follow-up visits, standard diabetes education delivered by healthcare professionals, and general advice on diabetes self-management and foot care as typically offered by the clinic. No additional structured education sessions, mobile reminder messages, or digital support interventions are provided during the study period. Outcome assessments are conducted at baseline, 3 months, and 6 months according to the study protocol.

Behavioral: Usual Care

Interventions

Participants in the intervention group receive a structured diabetes education program focusing on foot self-care behaviors, diabetes self-management, and prevention of foot complications. The education is delivered through scheduled face-to-face training sessions supported by educational materials. In addition, participants receive regular mobile reminder messages via a mobile application designed to reinforce self-care practices, medication adherence, daily foot inspection, and lifestyle modification. The mobile reminders are delivered multiple times per week throughout the study period to enhance behavioral adherence and self-efficacy.

Education + Mobile Reminder Program
Usual CareBEHAVIORAL

Four-session education on diabetes and diabetic foot care, plus WhatsApp group reminders (texts/brochures/videos) and periodic private reminder messages; includes a home visit and provision of a foot-care kit; follow-up for 6 months.

Usual Care (Control)

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18-65 years
  • Diagnosed with Type 2 Diabetes Mellitus
  • Able to read and understand Turkish
  • Owns a smartphone and uses WhatsApp
  • Provides written informed consent

You may not qualify if:

  • Type 1 diabetes or gestational diabetes
  • Severe cognitive impairment or psychiatric disorder
  • Active diabetic foot ulcer requiring hospitalization
  • Participation in another structured diabetes education program within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University Meram Medical Faculty Hospital

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator and PhD Candidate

Study Record Dates

First Submitted

March 1, 2026

First Posted

March 5, 2026

Study Start

February 10, 2026

Primary Completion (Estimated)

April 10, 2027

Study Completion (Estimated)

July 10, 2027

Last Updated

March 5, 2026

Record last verified: 2026-02

Locations