Education and Mobile Reminder Program for Foot Self-Care in Type 2 Diabetes

March 1, 2026 updated by: Selma Sahin

The Effect of Educatıonal Program and Remınder Mobıle Applıcatıons on Foot Self-Care Behavıors, Dıabetes Management Self-Effectıveness and Qualıty of Lıfe in Type 2 Dıabetes: A Randomızed Controlled Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic disorder associated with significant morbidity and mortality, including diabetic foot complications that may lead to infection, ulceration, and amputation. Effective foot self-care behaviors are essential to prevent these complications. However, many individuals with T2DM demonstrate insufficient knowledge and adherence to recommended self-care practices.

This randomized controlled trial was designed to evaluate the effectiveness of a structured education program combined with mobile reminder messages on foot self-care behaviors, diabetes management self-efficacy, and quality of life in individuals with T2DM.

Participants were randomly assigned to either an intervention group or a control group. The intervention group received a structured diabetes foot care education program and regular reminder messages delivered through mobile communication. The control group received standard care according to routine clinical practice.

Data were collected at baseline and during follow-up assessments. The primary outcome measure was foot self-care behavior. Secondary outcomes included diabetes management self-efficacy and quality of life. Validated measurement tools were used for all assessments.

The results of this study are expected to provide evidence regarding the effectiveness of education and mobile reminder interventions in improving self-care behaviors and preventing diabetes-related foot complications.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Konya, Turkey (Türkiye)
        • Necmettin Erbakan University Meram Medical Faculty Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Exclusion Criteria:
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Education + Mobile Reminder Program
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
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.
Active Comparator: Usual Care (Control)
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Diabetes Foot Self-Care Behavior Score
Time Frame: Baseline to 6 months
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Selma Sahin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2026

Primary Completion (Estimated)

April 10, 2027

Study Completion (Estimated)

July 10, 2027

Study Registration Dates

First Submitted

March 1, 2026

First Submitted That Met QC Criteria

March 1, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 1, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/395

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Diabetic Foot Diabetic Foot Care

Clinical Trials on Diabetes Education and Mobile Reminder Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe