NCT05473494

Brief Summary

The aim of this study is to determine the effect of online trainings on diabetic foot care on foot care behavior and self-efficacy attitudes of individuals with type II diabetes. Purpose in accordance with the patient's Diagnostic Information Form, diabetic foot care self-efficacy Scale(DABOO), foot care Behavior Scale(ABDO) and diabetic foot risk screening forms are available in the data collection tools; education and Research Hospital Internal Medicine outpatient clinic with Deeply Izmit Seka state hospital, inpatient or outpatient treatment for persons with Type II diabetes who agree to volunteer to participate in research 90 shall apply. After that, the groups will be divided into two groups by randomization, and one of the groups will be given training sessions consisting of min 20 max 40 minutes for diabetic foot care in 5 sessions for nine weeks. After the training, the scales will be applied to the groups again. The data obtained before and after the training will be compared statistically in a computer environment

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
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

8 months

First QC Date

June 22, 2022

Last Update Submit

July 21, 2022

Conditions

Keywords

Type2diabetesDiabeticFootCareOnlineEducationalDistanceEducationSelf-Effectıveness

Outcome Measures

Primary Outcomes (1)

  • Diabetic Foot Care Self-Efficacy Scale

    Self-efficacy is measured by scoring between 0 and 10. The 9 expressions that make up the scale are evaluated on the 11-digit visual scale, which is specified as -Not sure=0 and very sure=10. The lowest score of the scale is 0 and the highest score is 100. As the score obtained from the scale increases, the diabetic foot self-efficacy level increases in parallel.

    nine weeks

Secondary Outcomes (1)

  • Foot Care Behavıor Scale

    nine weeks

Study Arms (2)

training group

EXPERIMENTAL
Other: training group

control group

ACTIVE COMPARATOR
Other: control group

Interventions

Trainings on diabetic foot care consisting of min 20 max 40 minutes will be given in 5 sessions for nine weeks. Training will be given face to face online.

training group

Group not to be trained.

control group

Eligibility Criteria

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

You may qualify if:

  • Patients who were applied the Dietetic Foot Risk Screening form during the physician's examination and who were in the low and medium risk groups after the physician's examination.
  • To be able to read and write.
  • Being between the ages of 18-65.
  • Being on oral antidiabetic (OAD) and/or insulin therapy.
  • No restriction of access to the Internet.
  • To be able to use the Zoom program or WhatsApp video conversation with or without support.
  • Having computer and/or telephone skills.
  • Volunteering to participate in the study (Informed consent form will be signed by the participants during the application)
  • Not having sensory loss such as speech and hearing that prevents communication and no psychiatric problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ev

Kocaeli, Izmit, 41500, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Interventions

Sensitivity Training GroupsControl Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Psychotherapy, GroupSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and ActivitiesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Ayşegül Kandemir

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 22, 2022

First Posted

July 26, 2022

Study Start

January 1, 2022

Primary Completion

August 25, 2022

Study Completion

September 1, 2022

Last Updated

July 26, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations