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THE EFFECT OF ONLINE TRAINING ON FOOT CARE

Primary Purpose

Type2diabetes, Diabetic Foot

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
training group
control group
Sponsored by
Maltepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type2diabetes focused on measuring Type2diabetes, DiabeticFootCare, OnlineEducational, DistanceEducation, Self-Effectıveness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

outside the inclusion criteria.

Sites / Locations

  • EvRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

training group

control group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Foot Care Behavıor Scale
Consisting of 15 items in a 5-point Likert type, the scale is scored according to agree-disagree (1= Never, 2= Occasionally, 3= Sometimes, 4= Often, and 5= Always) and consists of 15 items. The lowest score that can be obtained from the scale, which evaluates foot care behavior as a single dimension, is 15 and the highest score is 75. An increase in the scale score indicates that the individual's foot self-care behaviors become positive.

Full Information

First Posted
June 22, 2022
Last Updated
July 21, 2022
Sponsor
Maltepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05473494
Brief Title
THE EFFECT OF ONLINE TRAINING ON FOOT CARE
Official Title
THE EFFECT OF ONLINE TRAININGS ON DIABETIC FOOT CARE ON FOOT CARE BEHAVIOR AND SELF-EFFECTIVENESS ATTITUDES OF INDIVIDUALS WITH TYPE II DIABETES
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
August 25, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maltepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2diabetes, Diabetic Foot
Keywords
Type2diabetes, DiabeticFootCare, OnlineEducational, DistanceEducation, Self-Effectıveness

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
training group
Arm Type
Experimental
Arm Title
control group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
training group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
control group
Intervention Description
Group not to be trained.
Primary Outcome Measure Information:
Title
Diabetic Foot Care Self-Efficacy Scale
Description
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.
Time Frame
nine weeks
Secondary Outcome Measure Information:
Title
Foot Care Behavıor Scale
Description
Consisting of 15 items in a 5-point Likert type, the scale is scored according to agree-disagree (1= Never, 2= Occasionally, 3= Sometimes, 4= Often, and 5= Always) and consists of 15 items. The lowest score that can be obtained from the scale, which evaluates foot care behavior as a single dimension, is 15 and the highest score is 75. An increase in the scale score indicates that the individual's foot self-care behaviors become positive.
Time Frame
nine weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: outside the inclusion criteria.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayşegül Kandemir
Phone
5433837160
Ext
+90
Email
aysegul.kanfe@hotmail.com
Facility Information:
Facility Name
Ev
City
Kocaeli
State/Province
Izmit
ZIP/Postal Code
41500
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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THE EFFECT OF ONLINE TRAINING ON FOOT CARE

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