Diabetes Footcare Companion App for Patients and Carers

NCT ID: NCT05564728

Last Updated: 2024-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-23

Study Completion Date

2023-09-30

Brief Summary

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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

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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

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Diabetes Mellitus Foot Ulcer Diabetes Mellitus, Type 2 Diabetic Foot Diabetic Foot Infection Ulcer Foot Ulcer, Leg

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Intervention

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

Conversational Agent/Chatbot App

Intervention Type OTHER

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.

Interventions

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Conversational Agent/Chatbot App

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.

Intervention Type OTHER

Other Intervention Names

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Well Feet

Eligibility Criteria

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Inclusion Criteria

1. Patients diagnosed with type 2 diabetes and attending Tan Tock Seng Hospital Diabetes Clinic
2. Aged 21 years or above
3. Able to speak and read English
4. Own a smartphone or tablet
5. Can download the app
6. Have internet access
7. Able to give informed consent
8. Singapore nationality or permanent residents


1. Provide care for a type 2 diabetes patient for the past 6 months
2. Aged 21 years or above
3. Able to speak and read English
4. Own a smartphone or tablet
5. Can download the app
6. Have internet access
7. Able to give informed consent

Exclusion Criteria

1. Pregnant
2. Inpatient
3. Received formal training in medicine or allied health services
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tan Tock Seng Hospital

OTHER

Sponsor Role collaborator

Ministry of Health, Singapore

OTHER_GOV

Sponsor Role collaborator

Nanyang Technological University

OTHER

Sponsor Role lead

Responsible Party

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Ho Hau Yan Andy

Joint Associate Professor, Lee Kong Chian School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liew Hui Ling, MBBS

Role: PRINCIPAL_INVESTIGATOR

Tan Tock Seng Hospital

Locations

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

Singapore, , Singapore

Site Status

Tan Tock Seng Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

References

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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.

Reference Type BACKGROUND
PMID: 37988150 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40342512 (View on PubMed)

Other Identifiers

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NanyangTU_WellFeet

Identifier Type: -

Identifier Source: org_study_id

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