NCT05564728|CompletedDMC
Diabetes Footcare Companion App for Patients and Carers
A Feasibility Study of a Conversational Agent App for Empowering Foot Care Literacy Among People With Diabetes and Their Carers
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A Feasibility Study of a Conversational Agent App for Empowering Foot Care Literacy Among People With Diabetes and Their Carers
Sponsor study identifier
observational
40
1 country
2
Study Start
June 23, 2023
Actual (reported)Primary Completion
September 30, 2023
Actual (reported)Study Completion
September 30, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 29, 2022
Actual (reported)October 3, 2022
Actual (reported)June 23, 2023
Actual (reported)September 30, 2023
Actual (reported)September 30, 2023
Actual (reported)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
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.
All participants will receive a conversational agent app, Well Feet, to support them in learning foot care self-management.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients diagnosed with type 2 diabetes and their carer
Nanyang Technological University, Center for Population Health Sciences, Lee Kong Chian School of Medicine
Singapore, 308232, Singapore
Tan Tock Seng Hospital
Singapore, 308232, Singapore
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.
Still 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.
Liew Hui Ling, MBBS
Tan Tock Seng Hospital
40 participants (actual enrollment reported by the registry).
First Submitted
September 29, 2022
First Posted
October 3, 2022
Study Start
June 23, 2023
Actual (reported)end-of-trial (1 month)
Changes in foot care knowledge among patients and carers at baseline and end-of-trial (1 month).
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).
baseline and end-of-trial (1 month)
Changes in carer's quality of life at the baseline and end-of-trial.
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).
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).
end-of-trial (1 month)
Contact the study team to confirm eligibility.
Primary Completion
September 30, 2023
Actual (reported)Study Completion
September 30, 2023
Actual (reported)Last Updated
January 19, 2024
Record last verified: 2024-01
Patient data will be anonymised and aggregated for analysis.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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