Evaluation of The Effectiveness of m-DAKBAS on Foot Care

Diabetic Foot Clinical Trial

Official title:

Evaluation of The Effectiveness of Mobile Diabetic Foot Personal Care System (m-DAKBAS) in Diabetic Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04029103
• Other study ID #: SankoM
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: July 29, 2018

Study information

• Verified date: July 2019
• Source: Sanko University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim: To develop the Mobile Diabetic Foot Personal Care System (m-DAKBAS) related to foot care for diabetic individuals and to evaluate its effectiveness.

Method: The study involved 88 patients who applied to the Diabetes Polyclinic (intervention=44; control=44). While the intervention group used m-DAKBAS (for 6 months), the control group was provided with a verbal foot care training once, as a standardized procedure of the hospital. Data were collected using the "Socio-demographic Form", "Diabetic Foot Knowledge Form - DFKF", "Foot Self Care Behaviours Scale -FSCBS", "Diabetic Foot Care Self Efficacy Scale - DFCSES", and "m-DAKBAS Assessment Form".

Description:

Diabetic foot, one of the important complications of diabetes, is a health problem that affects quality of life in a negative way, that has high treatment and care costs and mortality rates, long hospitalization duration and thus with all these aspects a psychological, physical, social and economic priority. Despite all these, diabetic foot complications and amputations could be decreased with the help of a good foot care, education and a multidisciplinary team work. Mobile technologies have been continuously increasing worldwide for the management of diabetes, and the use of these technologies is recommended by international institutions as well.

Therefore, the purpose of this study is to develop a Turkish mobile application that would increase patients' knowledge levels about foot health and care, improve their behaviours and self-efficacy, and evaluate its effectiveness so that it could be possible to prevent foot ulcer and the related amputations in individuals with diabetes. The Mobile Diabetic Foot Personal Care System (m-DAKBAS) developed for this purpose enables to increase individuals' self-confidence, improve communication with the health personnel, involve patients in their own care in an interactive way, and take responsibility.

The usability of the application was indicated by the patients' feedback, and in line with the purpose of the mobile application, improvements in the patients' knowledge, behaviours and self-efficacy about foot care in diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: July 29, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• having a diagnosis history of >1 year;

• having Type 1 or Type 2 diabetes;

• having a mobile phone with Android or IOS operating system;

Exclusion Criteria:

• having visual impairment,

• hand skill problem, difficulty in communication, or mental insufficiency;

• currently having foot ulcer.

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic
• Health Knowledge, Attitudes, Practice

Intervention

Other:
• knowledge, behaviour, self efficacy
Knowledge, behavior and self-efficacy of both groups were measured before and after the study.

Locations

Country	Name	City	State
Turkey	SANKO University	Sehitkamil

Sponsors (2)

Lead Sponsor	Collaborator
Sanko University	Koç University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge	Diabetic Foot Knowledge Form (DFKF) included 20 questions that aim to measure the knowledge level of individuals with diabetes about diabetic foot and foot care. The questions had three options (True, False, I don't know). Each correct answer was scored 1 point. Higher scores indicate higher knowledge levels	before the intervention- Immediately after the intervention
Primary	Behaviour	Foot Self Care Behaviours Scale is composed of 15 items which were assessed as 1=Never, 2=Rarely, 3=Sometimes, 4=Frequently, 5=Always). Scores range between 15 and 75. Higher scores indicate better self care behaviours	before the intervention- Immediately after the intervention
Primary	self-efficacy	Diabetic Foot Care Self Efficacy Scale has nine items which are rated on an 11-item visual scale that range from 0=I find it totally insufficient and 10= I find it totally sufficient. Scores to be obtained from the scale range between 0 and 90. Higher scores indicate higher self-efficacy	before the intervention- Immediately after the intervention