NCT05564728

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

June 23, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

September 29, 2022

Last Update Submit

January 18, 2024

Conditions

Diabetes Mellitus Foot UlcerDiabetes Mellitus, Type 2Diabetic FootDiabetic Foot InfectionUlcer FootUlcer, Leg

Keywords

Conversational AgentChatbotDiabetes LiteracyDiabetes KnowledgeSelf ManagementDigital TherapeuticsDigital Health

Outcome Measures

Primary Outcomes (2)

  • 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.

    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).

    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)

  • +6 more secondary outcomes

Study Arms (1)

Intervention

All participants will receive a conversational agent app, Well Feet, to support them in learning foot care self-management.

Other: Conversational Agent/Chatbot App

Interventions

Conversational Agent/Chatbot AppOTHER

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.

Also known as: Well Feet
Intervention

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with type 2 diabetes and their carer

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • Pregnant
  • Inpatient
  • Received formal training in medicine or allied health services

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nanyang Technological University, Center for Population Health Sciences, Lee Kong Chian School of Medicine

Singapore, 308232, Singapore

Location

Tan Tock Seng Hospital

Singapore, 308232, Singapore

Location

Related Publications (2)

  • 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.

    PMID: 37988150BACKGROUND

  • 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.

    PMID: 40342512DERIVED

MeSH Terms

Conditions

Diabetic FootDiabetes Mellitus, Type 2Foot UlcerLeg Ulcer

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic NeuropathiesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesFoot Diseases

Study Officials

  • Liew Hui Ling, MBBS

    Tan Tock Seng Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Joint Associate Professor, Lee Kong Chian School of Medicine

Study Record Dates

First Submitted

September 29, 2022

First Posted

October 3, 2022

Study Start

June 23, 2023

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

January 19, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Patient data will be anonymised and aggregated for analysis.

Locations

SG(2)