A Feasibility Study Comparing Usual Foot Education and Phone App Alerts in Patients With Increased Risk of Diabetic Foot

August 16, 2022 updated by: Dasman Diabetes Institute

A Feasibility Study to Compare Usual Methods of Patient Education With a Multi-media Presentation and Weekly 'Foot-alerts' Using 21st Century Technologies to Improve Patient Diabetic Foot Care Knowledge and Practices

The purpose of this study is to compare foot care knowledge, behaviour and glycaemic control in patients at increased risk of diabetic foot ulcers. Participants will receive either usual diabetic foot care education and follow-up as per evidence-based guidelines or usual care and follow-up, supplemented with an educational video and weekly foot alerts via a phone application.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

It is recommended that patients who are at moderate or high risk of diabetic foot ulcer (DFU) are seen by a healthcare professional for foot review every 2-6 months. Yet, diabetic foot ulcers remain the leading cause of non-traumatic lower limb amputation with an amputation occurring every 20 secs. This suggests that additional information and prompts, as well as regular follow-up, are required. Additionally, long term diabetic foot complications including loss of protective pain sensation are related to poor glycaemic control.

This single blinded randomised study aims to determine if weekly foot alerts (a total of 12 alerts cycled over 12-months), delivered by the MyU phone application in combination with usual education routes and follow-up, improves patient foot care behaviour and foot care knowledge. Using standardized questionnaires at baseline and 12-months. Furthermore, does the frequency of viewing/engaging in foot alert content influence foot care knowledge and behaviour.

Secondary objectives are to determine: 1) if individuals who receive 7-foot review appointments in a 12-month period have better foot care knowledge and behaviour when compared to those seen less frequently regardless of educational route. 2) Baseline and 12-months HbA1c blood test will be measured to establish if any changes occurred between the two groups.

Expected results: The investigators hypothesized that participants randomised to the intervention group (Phone app) will have improved foot care knowledge and foot health behaviours.

Sample size: 100 patients with a 1:1 ratio

Quality Assurance:

A standard operating procedure based on established diabetic foot screening tools will be used to ensure the inter-rater reliability of foot assessment.

Educational material will go through back translation to ensure the accuracy of the content. Feedback on content, meaning and usability of the English and Arabic documents from a sample of 10 participants will be sought.

To maintain investigator blinding the participants will be escorted to the video viewing room by a research coordinator.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female 21 yrs or
  • Type 2 Diabetes Mellitus or Type 1 Diabetes Mellitus greater than 5-yrs
  • At least one diabetic foot risk factor (i.e Loss of Pain Sensation Peripheral Arterial Disease etc)
  • Ability to understand Arabic or English to a skill listening level 3 and speaking level +2 (Interagency Language Roundtable).
  • Own a smartphone and access to the internet
  • The ability to understand the study procedures and to comply with them for the entire length of the study
  • Resident in Kuwait

Exclusion Criteria:

  • Chronic kidney disease stage 3 or above
  • Cognitive impairment
  • Acute psychiatric illness
  • Hearing or visual impairment that would mean the intervention would not be understood
  • phone application inaccessible for more than 4 continuous weeks
  • Refusal to give written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phone application arm
Participants will have access to a educational video and foot alerts at weekly intervals to supplement usual Podiatry care and education.
Device: Phone application
Weekly foot alerts and educational video
Other Names:
  • MyU smart phone application
Other: Usual care
Participants will have Podiatry care and education.
Other: Usual care
Usual routine of diabetic foot education
Other Names:
  • Routine Podiatry education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in foot care knowledge as measured by the adapted foot care knowledge test
Time Frame: 12 months
Change in the adapted Diabetic Foot Care Knowledge test (Pollock et al. 2004 and Rheeder et al. 2008) score between baseline and 12-months in the two groups This 12-question test has a maximum score of 12, and a minimum score of 0. Each correct answer is given one point, where a low score denotes low knowledge and high score denotes high knowledge. For each group a mean will be calculated and significance of differences will be tested using the students two tailed unpaired T-Test.
12 months
Change in foot care behaviour as measured by the SDSCA
Time Frame: 12 months

SDCS questionnaire includes a number of domains which evaluate different aspects of patient behaviour performed during the previous week. Each domain has one or more questions that are marked between 0-7. The domains are:

  1. Foot care: total of 9 questions with maximum score 9x7 = 63, the greater the score the better the behaviour
  2. Diabetes Management: 4 questions in diabetes management, maximum score 4x7 = 28, the greater the score the better the behaviour
  3. Smoking habits: number of cigarettes per day, the greater the number the worse the behaviour

These measures allow formulation of a composite reflection in changes in the patient's behaviour between baseline and 12-months in the two groups. Differences will be tested using the students two-tailed unpaired T-Test.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c from baseline
Time Frame: 12 months
Change in HbA1c measurement taken from venous blood supply at baseline and 12-months between intervention and control group.
12 months
Proportion of participants who developed a new diabetic foot ulcer
Time Frame: 12 months
Case report form. Diabetic foot ulcer is defined as a wound below the ankle in someone with diabetes and will be classified using the University of Texas Wound classification System.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dasman Diabetes Institute

Collaborators

Kuwait Foundation for the Advancement of Sciences

Investigators

  • Principal Investigator: Kay Scarsbrook Khan, BSc, Dasman Diabetes Institute
  • Principal Investigator: Ebaa Al Ozairi, MD, Dasman Diabetes Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2019

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

March 6, 2019

First Submitted That Met QC Criteria

April 29, 2019

First Posted (Actual)

May 2, 2019

Study Record Updates

Last Update Posted (Actual)

August 17, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA HM-2018_044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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