Evaluation of The Effectiveness of m-DAKBAS on Foot Care

NCT04029103 | Completed DMC

• 1 other identifier: SankoM
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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".

Conditions

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

Keywords

Diabetic foot; health technology; mobile application

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

used m-DAKBAS

ACTIVE COMPARATOR

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.

Other: knowledge, behaviour, self efficacy

not used m-DAKBAS

EXPERIMENTAL

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)

Other: knowledge, behaviour, self efficacy

Interventions

knowledge, behaviour, self efficacy OTHER

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

not used m-DAKBAS; used m-DAKBAS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• having a diagnosis history of \>1 year;
• having Type 1 or Type 2 diabetes;
• having a mobile phone with Android or IOS operating system;

You may not qualify if:

• having visual impairment,
• hand skill problem, difficulty in communication, or mental insufficiency;
• currently having foot ulcer.

Sponsors & Collaborators

• Sanko University: lead
• Koç University: collaborator

Study Sites (1)

SANKO University

Şehitkamil, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetic Foot; Behavior

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 23, 2019
• Study Start: June 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: July 29, 2018
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after research published

Locations

TU (1)