Clinical trial NCT04029103: Evaluation of The Effectiveness of m-DAKBAS on Foot Care
Official title: Evaluation of The Effectiveness of Mobile Diabetic Foot Personal Care System (m-DAKBAS) in Diabetic Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot
Foot Ulcer, Diabetic
Health Knowledge, Attitudes, Practice
Keywords: Diabetic foot
health technology
mobile application
Lead sponsor: Sanko University
Sponsor class: OTHER
Collaborators: name: Koç University
First posted: 2019-07-23
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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".

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Knowledge
timeFrame: before the intervention- Immediately after the intervention
measure: Behaviour
timeFrame: before the intervention- Immediately after the intervention
measure: self-efficacy
timeFrame: before the intervention- Immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Şehitkamil
country: Turkey
facility: SANKO University
Study officials:
References: