search
Back to results

Evaluation of The Effectiveness of m-DAKBAS on Foot Care

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
knowledge, behaviour, self efficacy
Sponsored by
Sanko University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Foot focused on measuring Diabetic foot, health technology, mobile application

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • SANKO University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

used m-DAKBAS

not used m-DAKBAS

Arm Description

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.

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)

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Full Information

First Posted
June 26, 2019
Last Updated
July 22, 2019
Sponsor
Sanko University
Collaborators
Koç University
search

1. Study Identification

Unique Protocol Identification Number
NCT04029103
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
July 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanko University
Collaborators
Koç University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot, Foot Ulcer, Diabetic, Health Knowledge, Attitudes, Practice
Keywords
Diabetic foot, health technology, mobile application

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
used m-DAKBAS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
not used m-DAKBAS
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
knowledge, behaviour, self efficacy
Intervention Description
Knowledge, behavior and self-efficacy of both groups were measured before and after the study.
Primary Outcome Measure Information:
Title
Knowledge
Description
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
Time Frame
before the intervention- Immediately after the intervention
Title
Behaviour
Description
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
Time Frame
before the intervention- Immediately after the intervention
Title
self-efficacy
Description
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
Time Frame
before the intervention- Immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
SANKO University
City
Şehitkamil
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
the article has been sent to the journal for publication
IPD Sharing Time Frame
after research published

Learn more about this trial

Evaluation of The Effectiveness of m-DAKBAS on Foot Care

We'll reach out to this number within 24 hrs