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Evaluation of The Effectiveness of m-DAKBAS on Foot Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04029103
Recruitment Status : Completed
First Posted : July 23, 2019
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
Koç University
Information provided by (Responsible Party):
Sanko University

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".


Condition or disease Intervention/treatment Phase
Diabetic Foot Foot Ulcer, Diabetic Health Knowledge, Attitudes, Practice Other: knowledge, behaviour, self efficacy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of The Effectiveness of Mobile Diabetic Foot Personal Care System (m-DAKBAS) in Diabetic Individuals
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : July 29, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.

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

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




Primary Outcome Measures :
  1. Knowledge [ Time Frame: before the intervention- Immediately after the intervention ]
    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

  2. Behaviour [ Time Frame: before the intervention- Immediately after the intervention ]
    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

  3. self-efficacy [ Time Frame: before the intervention- Immediately after the intervention ]
    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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04029103


Locations
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Turkey
SANKO University
Şehitkamil, Turkey
Sponsors and Collaborators
Sanko University
Koç University

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Responsible Party: Sanko University
ClinicalTrials.gov Identifier: NCT04029103    
Other Study ID Numbers: SankoM
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: the article has been sent to the journal for publication
Supporting Materials: Study Protocol
Time Frame: after research published

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sanko University:
Diabetic foot
health technology
mobile application
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases