Diabetic FootNCT03934944
A Feasibility Study Comparing Usual Foot Education and Phone App Alerts in Patients With Increased Risk of Diabetic Foot
A study testing Phone application in people with Diabetic Foot and Diabetic Foot Ulcer, run by Dasman Diabetes Institute at 1 site in Kuwait.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetic Foot, Diabetic Foot Ulcer
- What is being tested?
- Phone application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteKuwait
- Study dates
- 10 Feb 2019to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Kuwait1 site, 1 recruiting
- Recruiting
Dasman Diabetes Institute
Kuwait City
Kay Scarsbrook Khan, BSc, +96522242999 ext. 6815, kay.khan@dasmaninstitute.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer
- Being tested
- Phone application, Usual care
- Keywords
- Patient education, Prevention, Smart phone application
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone applicationDevice
Also called MyU smart phone application
Weekly foot alerts and educational video
Usual careOther
Also called Routine Podiatry education
Usual routine of diabetic foot education
| Study group | Role | What they receive |
|---|---|---|
| Phone application arm | Experimental | Participants will have access to a educational video and foot alerts at weekly intervals to supplement usual Podiatry care and education. Receives: Device: Phone application |
| Usual care | Other | Participants will have Podiatry care and education. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in foot care knowledge as measured by the adapted foot care knowledge test
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.
Measured: 12 months
Change in foot care behaviour as measured by the SDSCA
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:
- Foot care: total of 9 questions with maximum score 9x7 = 63, the greater the score the better the behaviour
- Diabetes Management: 4 questions in diabetes management, maximum score 4x7 = 28, the greater the score the better the behaviour
- 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.
Measured: 12 months
Secondary outcomes (2)
Change in HbA1c from baseline
Change in HbA1c measurement taken from venous blood supply at baseline and 12-months between intervention and control group.
Measured: 12 months
Proportion of participants who developed a new diabetic foot ulcer
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start10 Feb 2019
- Primary completionFeb 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dasman Diabetes Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Kuwait Foundation for the Advancement of Sciences
- Responsible party
- Sponsor
- Investigators
- Kay Scarsbrook Khan, BSc, Principal investigator, Dasman Diabetes InstituteEbaa Al Ozairi, MD, Principal investigator, Dasman Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934944
- Sponsor's protocol ID
- RA HM-2018_044
- Status last verified
- Aug 2021
- First submitted
- 6 Mar 2019
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alawadhi A, Khan KS, Messenger G, Cusworth A, Assi M, Gray SR, Al-Ozairi E. Long-Term Effects of Multimedia Education and "Foot Alerts" Through the MyU App on Diabetic Foot Care in Individuals With Moderate-High Risk: Pilot Randomized Controlled Trial. JMIR Hum Factors. 2026 Jan 13;13:e78261. doi: 10.2196/78261.
PubMed 41528867
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03934944
- Acronym / sponsor ID
- RA HM-2018_044
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer
- Keywords
- Patient education, Prevention, Smart phone application
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dasman Diabetes InstituteUniversity, hospital or other
- Collaborators
- Kuwait Foundation for the Advancement of Sciences
- Study start
- 10 Feb 2019 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Phone application arm | Experimental | Device: Phone applicationParticipants will have access to a educational video and foot alerts at weekly intervals to supplement usual Podiatry care and education. |
| Usual care | Other | Other: Usual careParticipants will have Podiatry care and education. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone applicationAlso: MyU smart phone applicationWeekly foot alerts and educational video | Device | Phone application arm |
| Usual careAlso: Routine Podiatry educationUsual routine of diabetic foot education | Other | Usual care |
Primary outcome
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.
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.
2 secondary outcomes
Change in HbA1c from baseline
Time frame: 12 months
Proportion of participants who developed a new diabetic foot ulcer
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Derived from this study: PubMed 41528867Alawadhi A, Khan KS, Messenger G, Cusworth A, Assi M, Gray SR, Al-Ozairi E. Long-Term Effects of Multimedia Education and "Foot Alerts" Through the MyU App on Diabetic Foot Care in Individuals With Moderate-High Risk: Pilot Randomized Controlled Trial. JMIR Hum Factors. 2026 Jan 13;13:e78261. doi: 10.2196/78261.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kay Scarsbrook Khan, BSc principal investigator
Dasman Diabetes Institute
Ebaa Al Ozairi, MD principal investigator
Dasman Diabetes Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone application in people with Diabetic Foot and Diabetic Foot Ulcer, run by Dasman Diabetes Institute at 1 site in Kuwait.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kuwait. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kay Scarsbrook Khan, BSc (+965 22242999 ext. 6815, kay.khan@dasmaninstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in foot care knowledge as measured by the adapted foot care knowledge test (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03934944, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.