NCT06213337

Brief Summary

The type of this research is a randomized controlled experimental study. The aim of the research is to determine the effectiveness of virtual classroom training and SMS support in improving foot care behaviour and foot care self-efficacy in diabetic patients. The basic questions the research aims to answer are:

  • Is virtual classroom training effective in improving foot care behaviour and foot care self-efficacy in diabetic patients?
  • Are SMS-supported interventions effective in improving foot care behaviour and foot care self-efficacy in diabetic patients? Within the scope of the research, participants are expected to attend virtual classroom training and read the SMS sentences sent. In order to examine the effects of virtual classroom training and SMS-supported interventions, researchers created a control group, a virtual classroom, an SMS support group, and an SMS-supported virtual classroom group.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

March 1, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2023

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 19, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

10 months

First QC Date

December 14, 2023

Last Update Submit

January 9, 2024

Conditions

Keywords

diabetic footvirtual systemsShort Message Service

Outcome Measures

Primary Outcomes (2)

  • Development of foot care behavior in diabetic patients

    Foot Care Behavior Scale Total Score increasing

    within 3 months

  • Development of foot care self-efficacy in diabetic patients

    Foot Care Self-Efficacy Scale Total Score increasing

    within 1 months

Study Arms (4)

control group

NO INTERVENTION

No intervention will be applied to this group.

virtual classroom group

EXPERIMENTAL

Participants in this group will be given virtual classroom training on foot care.

Other: Foot care training with virtual classroom

SMS support group

EXPERIMENTAL

Information regarding foot care will be sent via SMS to the participants in this group.

Other: Foot care training with SMS support

SMS supported virtual classroom training group

EXPERIMENTAL

Participants in this group will be given virtual classroom training with SMS support.

Other: Foot care training with virtual classroom and SMS support

Interventions

Providing foot care training once every two weeks in virtual classes created via the Google meet application.

virtual classroom group

Total of 60 SMS messages containing foot care information will be sent, one every day.

SMS support group

Providing foot care training once every two weeks in virtual classes created via the Google meet application. Furthermore, total of 60 SMS messages containing foot care information will be sent, one every day.

SMS supported virtual classroom training group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Reporting that you have internet, computer/smartphone access
  • Becoming literate
  • Ability to use the internet and mobile devices effectively
  • Declaring that you are competent to use technology-based training
  • Being between the ages of 18-55
  • Diagnosis period of 1 year or more

You may not qualify if:

  • Having a psychiatric/neurological disability that may prevent participation in the research
  • Having any diagnosis of learning disability
  • Having an existing foot ulcer
  • Having a history of foot ulcers and amputation in the past
  • Having severe vision problems/retinopathy
  • Having severe hearing impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayıs University

Samsun, Atakum, 55270, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Burak Arslan, Lecturer

    Hitit University

    PRINCIPAL INVESTIGATOR
  • Afitap Özdelikara, Assoc. Prof.

    Ondokuz Mayıs University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 14, 2023

First Posted

January 19, 2024

Study Start

March 1, 2023

Primary Completion

January 1, 2024

Study Completion

April 1, 2024

Last Updated

January 19, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations