Diabetes Mellitus Foot UlcerNCT05564728
Diabetes Footcare Companion App for Patients and Carers
An observational study of Diabetes Mellitus Foot Ulcer and Diabetes Mellitus, Type 2, run by Nanyang Technological University at 2 sites in Singapore.
Trial summary
Diabetes education and self-management support can be delivered via mobile phones. This protocol aims to assess the feasibility and acceptability of Well Feet, a conversational agent, as a diabetic foot care companion. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes Mellitus Foot Ulcer, Diabetes Mellitus, Type 2, Diabetic Foot
- What is being tested?
- Conversational Agent/Chatbot App
- How many people
- 40 participants
- Where
- 2 sitesSingapore
- Study dates
- 23 Jun 2023to 30 Sep 2023
- Phase
- Observational
- 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
Study population: Patients diagnosed with type 2 diabetes and their carer
Who may be able to join
- Patients diagnosed with type 2 diabetes and attending Tan Tock Seng Hospital Diabetes Clinic
- Aged 21 years or above
- Able to speak and read English
- Own a smartphone or tablet
- Can download the app
- Have internet access
Show all 15Show fewer
- Able to give informed consent
- Singapore nationality or permanent residents
- Provide care for a type 2 diabetes patient for the past 6 months
- Aged 21 years or above
- Able to speak and read English
- Own a smartphone or tablet
- Can download the app
- Have internet access
- Able to give informed consent
Who cannot join
- Pregnant
- Inpatient
- Received formal training in medicine or allied health services
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Nanyang Technological University, Center for Population Health Sciences, Lee Kong Chian School of Medicine
Singapore, 308232
Tan Tock Seng Hospital
Singapore, 308232
About this study
Official title: A Feasibility Study of a Conversational Agent App for Empowering Foot Care Literacy Among People With Diabetes and Their Carers
Diabetes education and self-management support can be delivered via mobile phones. This protocol aims to assess the feasibility and acceptability of Well Feet, a conversational agent, as a diabetic foot care companion. By utilizing feedback and responses to evaluative questions posted on the app's interface, the investigators intend to examine the app's technical, functional, and operational feasibility.
Read the detailed description
Diabetes puts patients with diabetes at risk of foot complications. Besides well managed diabetes, providing diabetes foot care education and self-management support is key to reducing the risk of developing diabetic foot ulcers, a serious and costly complication of diabetes. Although, education and self-management support for people with diabetes can improve patients' quality of life, they are still commonly not provided or inadequate. Digital technologies have the potential to offer a new convenient, interactive, and engaging mode of self-management education and support.
This study aims to examine the feasibility of the Well Feet app for diabetes foot care education and self-management support in promoting optimal foot care behaviour. In recognizing that many people with diabetes, especially the elderly, require the support of informal carers, the app also targets their knowledge and support needs.
- Conditions
- Diabetes Mellitus Foot Ulcer, Diabetes Mellitus, Type 2, Diabetic Foot, Diabetic Foot Infection, Ulcer Foot, Ulcer, Leg
- Being tested
- Conversational Agent/Chatbot App
- Keywords
- Conversational Agent, Chatbot, Diabetes Literacy, Diabetes Knowledge, Self Management, Digital Therapeutics, Digital Health
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Type 2, Foot Ulcer, Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conversational Agent/Chatbot AppOther
Also called Well Feet
Well Feet is developed based on adaptive learning frameworks to deliver diabetes foot care education through a conversational agent. The learning path for each participant will be customised based on their responses to pre-module quizzes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | All participants will receive a conversational agent app, Well Feet, to support them in learning foot care self-management. Receives: Other: Conversational Agent/Chatbot App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of a health app among patients and carers at the end of the trial (1 month)
A validated questionnaire, MHealth App Usability Questionnaire, will be used to determine the usefulness and applicability of an app with a conversational agent/chatbot among patients and carers. The questionnaire consists of 3 subscales, which are ease of use (5 items), interface and satisfaction (7 items), and usefulness (6 items). Participants rate each of the items using a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). The usability of the app is determined by the total and average of all statements-the higher the overall average, the better the usability of the app. However, if the average score is lower than 4, it means that the usability of the app is not good
Measured: end-of-trial (1 month)
Qualitative perspective on a conversational agent/chatbot app usage experience among patients and carers at the end of the trial (1 month).
A focus group discussion among the app user will be done to collect feedback on the user experience at the end of the trial. Qualitative data on app usability, app applicability, app relevance and user feedback will be retrieved from the focus group discussion.
Measured: end-of-trial (1 month)
Secondary outcomes (11)
Changes in foot care knowledge among patients and carers at baseline and end-of-trial (1 month).
A validated questionnaire, Foot Care Knowledge Questionnaire (FTC) will be used to evaluate changes in patient's and carer's knowledge on foot care from baseline to the end-of-trial. The questionnaire consists of 12 items to be rate true or false and the score will be presented in term of percentage of correct answer. Higher percentage of correct answers means higher level of foot care knowledge.
Measured: baseline and end-of-trial (1 month)
Changes in foot care related self-management behaviour among patients at baseline and end-of-trial (1 month).
A validated questionnaire, Nottingham Assessment of Functional Footcare (Revised 2015) will be used to assess changes in patient's level of foot care related self-management behaviour from baseline to the end-of-trial. This questionnaire consists of 29 items on a 5-point Likert scale. The total number of scores will be added up and multiply the score by 1.115 to obtain the final score. Higher score means better self-management care.
Measured: baseline and end-of-trial (1 month)
Changes in carer's quality of life at the baseline and end-of-trial.
A validated questionnaire, Brief Assessment Scale for Caregivers (BASC) will be used to determine changes in carer's quality of life and level of burden from caring for a person with diabetes. This questionnaire consists of 14 items clustered into 5 factors. The mean BASC score is computed by summing up the non-NA items in each factor, then dividing by the number of items that were not missing. This gave a score scaled from 0 to 3, with a higher score indicating better caregiver outcomes.
Measured: baseline and end-of-trial (1 month)
Login frequency in the conversational agent/chatbot app among patients and carers at the end of the trial (1 month).
Data on login frequency will be retrieved from the backend of the app at the end of trial.
Measured: end-of-trial (1 month)
Time spent on the app in the conversational agent/chatbot app among patients and carers at the end of the trial (1 month).
Data on total number of minutes spent on the app will be retrieved from the backend of the app at the end of trial.
Measured: end-of-trial (1 month)
Number of module accessed in the conversational agent/chatbot app among patients and carers at the end of the trial (1 month).
Data on total number of education module accessed will be retrieved from the backend of the app at the end of trial.
Measured: end-of-trial (1 month)
Number of module completed in the conversational agent/chatbot app among patients and carers at the end of the trial (1 month).
Data on number of education module completed will be retrieved from the backend of the app at the end of trial.
Measured: end-of-trial (1 month)
Module quizzes scores in the conversational agent/chatbot app among patients and carers at the end of the trial (1 month).
At the end of each module, users will be directed to a module quiz. Data on total scores for the module quizzes will be collected from the backend of the app at the end of trial.
Measured: end-of-trial (1 month)
Module rating in the conversational agent/chatbot app among patients and carers at the end of the trial (1 month).
At the end of each module, users will be prompted to rate their learning experience using a 5-point Likert scale. Data of the ratings on each of the modules will be collected from the backend of the app at the end of trial.
Measured: end-of-trial (1 month)
Overall app rating for the conversational agent/chatbot app among patients and carers at the end of the trial (1 month).
Upon completion of all learning modules, users will be prompted to rate their overall experience of using the app using a 5-point Likert scale. Data of the overall experience of app rating will be retrieved from the backend of the app at the end of trial.
Measured: end-of-trial (1 month)
Usability of a conversational agent/chatbot among patients and carers at the end of the trial (1 month).
A validated questionnaire, Chatbot Usability Questionnaire, will be used to determine the usefulness and applicability of a conversational agent/chatbot among patients and carers at the end of the trial. This questionnaire consists of 16 items on a 5-point Likert scale. The mean score will be calculated using CUQ calculator available on the Ulster University website. This higher mean score means better chatbot usability.
Measured: end-of-trial (1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start23 Jun 2023
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Foot UlcerStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanyang Technological University
- Sponsor type
- University, hospital or other
- Collaborators
- Tan Tock Seng Hospital, Ministry of Health, Singapore
- Responsible party
- Principal investigator, Ho Hau Yan Andy, Nanyang Technological University
- Investigators
- Liew Hui Ling, MBBS, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564728
- Sponsor's protocol ID
- NanyangTU_WellFeet
- Status last verified
- Jan 2024
- First submitted
- 29 Sep 2022
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data will be anonymised and aggregated for analysis.
Publications
Liew H, Pienkowska A, Ang CS, Mahadzir MDA, Goh KFI, Lodh N, Bojic I, Lawate A, Ong QC, Venkataraman K, Car J, Ho AHY. Empowering Foot Care Literacy Among People Living With Diabetes and Their Carers With an mHealth App: Protocol for a Feasibility Study. JMIR Res Protoc. 2023 Nov 21;12:e52036. doi: 10.2196/52036.
PubMed 37988150Still CH, Harwell C, Killion C, Sattar A, Viswanath SE. OPtimizing Technology to Improve Medication Adherence and BP Control (OPTIMA-BP) Invention Versus Waitlisted Group in African American Adults with Hypertension: A Randomized Control Trial Protocol. Nursing (Auckl). 2025;15:29-41. doi: 10.2147/nrr.s491609. Epub 2025 Mar 24.
PubMed 40342512
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of a Conversational Agent App for Empowering Foot Care Literacy Among People With Diabetes and Their Carers
- ClinicalTrials.gov ID
- NCT05564728
- Acronym / sponsor ID
- NanyangTU_WellFeet
- Conditions
- Diabetes Mellitus Foot Ulcer, Diabetes Mellitus, Type 2, Diabetic Foot, Diabetic Foot Infection, Ulcer Foot, Ulcer, Leg
- Keywords
- Conversational Agent, Chatbot, Diabetes Literacy, Diabetes Knowledge, Self Management, Digital Therapeutics, Digital Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nanyang Technological UniversityUniversity, hospital or other
- Collaborators
- Tan Tock Seng Hospital, Ministry of Health, Singapore
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 3 Oct 2022 (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.
Diabetes education and self-management support can be delivered via mobile phones. This protocol aims to assess the feasibility and acceptability of Well Feet, a conversational agent, as a diabetic foot care companion. By utilizing feedback and responses to evaluative questions posted on the app's interface, the investigators intend to examine the app's technical, functional, and operational feasibility.
Detailed description
Diabetes puts patients with diabetes at risk of foot complications. Besides well managed diabetes, providing diabetes foot care education and self-management support is key to reducing the risk of developing diabetic foot ulcers, a serious and costly complication of diabetes. Although, education and self-management support for people with diabetes can improve patients' quality of life, they are still commonly not provided or inadequate. Digital technologies have the potential to offer a new convenient, interactive, and engaging mode of self-management education and support.
This study aims to examine the feasibility of the Well Feet app for diabetes foot care education and self-management support in promoting optimal foot care behaviour. In recognizing that many people with diabetes, especially the elderly, require the support of informal carers, the app also targets their knowledge and support needs.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Other: Conversational Agent/Chatbot AppAll participants will receive a conversational agent app, Well Feet, to support them in learning foot care self-management. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with type 2 diabetes and their carer
Key inclusion criteria (15 listed)
- Patients diagnosed with type 2 diabetes and attending Tan Tock Seng Hospital Diabetes Clinic
- Aged 21 years or above
- Able to speak and read English
- Own a smartphone or tablet
- Can download the app
Key exclusion criteria (3 listed)
- Pregnant
- Inpatient
- Received formal training in medicine or allied health services
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 |
|---|---|---|
| Conversational Agent/Chatbot AppAlso: Well FeetWell Feet is developed based on adaptive learning frameworks to deliver diabetes foot care education through a conversational agent. The learning path for each participant will be customised based on their responses to pre-module quizzes. | Other | Intervention |
Primary outcome
Usability of a health app among patients and carers at the end of the trial (1 month)
Time frame: end-of-trial (1 month)
A validated questionnaire, MHealth App Usability Questionnaire, will be used to determine the usefulness and applicability of an app with a conversational agent/chatbot among patients and carers. The questionnaire consists of 3 subscales, which are ease of use (5 items), interface and satisfaction (7 items), and usefulness (6 items). Participants rate each of the items using a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). The usability of the app is determined by the total and average of all statements-the higher the overall average, the better the usability of the app. However, if the average score is lower than 4, it means that the usability of the app is not good
Qualitative perspective on a conversational agent/chatbot app usage experience among patients and carers at the end of the trial (1 month).
Time frame: end-of-trial (1 month)
A focus group discussion among the app user will be done to collect feedback on the user experience at the end of the trial. Qualitative data on app usability, app applicability, app relevance and user feedback will be retrieved from the focus group discussion.
11 secondary outcomes
Changes in foot care knowledge among patients and carers at baseline and end-of-trial (1 month).
Time frame: baseline and end-of-trial (1 month)
Changes in foot care related self-management behaviour among patients at baseline and end-of-trial (1 month).
Time frame: baseline and end-of-trial (1 month)
Changes in carer's quality of life at the baseline and end-of-trial.
Time frame: baseline and end-of-trial (1 month)
Login frequency in the conversational agent/chatbot app among patients and carers at the end of the trial (1 month).
Time frame: end-of-trial (1 month)
Time spent on the app in the conversational agent/chatbot app among patients and carers at the end of the trial (1 month).
Time frame: end-of-trial (1 month)
Number of module accessed in the conversational agent/chatbot app among patients and carers at the end of the trial (1 month).
Time frame: end-of-trial (1 month)
Number of module completed in the conversational agent/chatbot app among patients and carers at the end of the trial (1 month).
Time frame: end-of-trial (1 month)
Module quizzes scores in the conversational agent/chatbot app among patients and carers at the end of the trial (1 month).
Time frame: end-of-trial (1 month)
Module rating in the conversational agent/chatbot app among patients and carers at the end of the trial (1 month).
Time frame: end-of-trial (1 month)
Overall app rating for the conversational agent/chatbot app among patients and carers at the end of the trial (1 month).
Time frame: end-of-trial (1 month)
Usability of a conversational agent/chatbot among patients and carers at the end of the trial (1 month).
Time frame: end-of-trial (1 month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Background: PubMed 37988150Liew H, Pienkowska A, Ang CS, Mahadzir MDA, Goh KFI, Lodh N, Bojic I, Lawate A, Ong QC, Venkataraman K, Car J, Ho AHY. Empowering Foot Care Literacy Among People Living With Diabetes and Their Carers With an mHealth App: Protocol for a Feasibility Study. JMIR Res Protoc. 2023 Nov 21;12:e52036. doi: 10.2196/52036.
- Derived from this study: PubMed 40342512Still CH, Harwell C, Killion C, Sattar A, Viswanath SE. OPtimizing Technology to Improve Medication Adherence and BP Control (OPTIMA-BP) Invention Versus Waitlisted Group in African American Adults with Hypertension: A Randomized Control Trial Protocol. Nursing (Auckl). 2025;15:29-41. doi: 10.2147/nrr.s491609. Epub 2025 Mar 24.
- Individual participant dataSharing planned: No. Patient data will be anonymised and aggregated for analysis.
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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.
Liew Hui Ling, MBBS principal investigator
Tan Tock Seng Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus Foot Ulcer and Diabetes Mellitus, Type 2, run by Nanyang Technological University at 2 sites in Singapore.
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 15 inclusion and 3 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: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of a health app among patients and carers at the end of the trial (1 month) (time frame: end-of-trial (1 month)). 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 NCT05564728, which also lists 2 linked publications.
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 19 Jan 2024.