Evaluation of The Effectiveness of m-DAKBAS on Foot Care

NCT ID: NCT04029103

Last Updated: 2019-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2018-07-29

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

used m-DAKBAS

m-DAKBAS application was downloaded to the mobile phones of the participants who met the research criteria and accepted to participate in the study; the participants were given a username and a password for the confidentiality. They were instructed how to use the application after a number of trials.

The participants were asked to send their blood sugar levels each time they measured it and foot observations daily through the application. Using the admin panel, the researcher followed the participants' frequency of using the application and the data they sent throughout 24 weeks and tried to find solutions to the problems experienced (for example: hyperglycaemia, insulin dosage adjustments). The participants were provided with feedback in line with these data; SMS reminders were sent if the tasks were not completed.

Group Type: ACTIVE_COMPARATOR

knowledge, behaviour, self efficacy

Intervention Type: OTHER

Knowledge, behavior and self-efficacy of both groups were measured before and after the study.

not used m-DAKBAS

The participants who met the research criteria and accepted to participate in the study were given training via verbal instruction about the information in the content of m-DAKBAS (definition of Diabetic Foot, risk factors, protective precautions, daily foot care)

Group Type: EXPERIMENTAL

knowledge, behaviour, self efficacy

Intervention Type: OTHER

Knowledge, behavior and self-efficacy of both groups were measured before and after the study.

Interventions

knowledge, behaviour, self efficacy

Knowledge, behavior and self-efficacy of both groups were measured before and after the study.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Koç University

OTHER

Sponsor Role: collaborator

Sanko University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

SANKO University

Şehitkamil, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

SankoM

Identifier Type: -

Identifier Source: org_study_id