Clinical trial NCT05564728: Diabetes Footcare Companion App for Patients and Carers
Official title: A Feasibility Study of a Conversational Agent App for Empowering Foot Care Literacy Among People With Diabetes and Their Carers
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Nanyang Technological University
Sponsor class: OTHER
Collaborators: name: Tan Tock Seng Hospital
name: Ministry of Health, Singapore
First posted: 2022-10-03
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with type 2 diabetes and their carer

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.

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.

Eligibility criteria: Inclusion criteria for patients:

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

Inclusion criteria for carers:

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 for patients and carers:

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

Primary outcomes:
measure: Usability of a health app among patients and carers at the end of the trial (1 month)
timeFrame: end-of-trial (1 month)
measure: Qualitative perspective on a conversational agent/chatbot app usage experience among patients and carers at the end of the trial (1 month).
timeFrame: end-of-trial (1 month)
Secondary outcomes:
measure: Changes in foot care knowledge among patients and carers at baseline and end-of-trial (1 month).
timeFrame: baseline and end-of-trial (1 month)
measure: Changes in foot care related self-management behaviour among patients at baseline and end-of-trial (1 month).
timeFrame: baseline and end-of-trial (1 month)
measure: Changes in carer's quality of life at the baseline and end-of-trial.
timeFrame: baseline and end-of-trial (1 month)
measure: Login frequency in the conversational agent/chatbot app among patients and carers at the end of the trial (1 month).
timeFrame: end-of-trial (1 month)
measure: Time spent on the app in the conversational agent/chatbot app among patients and carers at the end of the trial (1 month).
timeFrame: end-of-trial (1 month)
measure: Number of module accessed in the conversational agent/chatbot app among patients and carers at the end of the trial (1 month).
timeFrame: end-of-trial (1 month)
measure: Number of module completed in the conversational agent/chatbot app among patients and carers at the end of the trial (1 month).
timeFrame: end-of-trial (1 month)
measure: Module quizzes scores in the conversational agent/chatbot app among patients and carers at the end of the trial (1 month).
timeFrame: end-of-trial (1 month)
measure: Module rating in the conversational agent/chatbot app among patients and carers at the end of the trial (1 month).
timeFrame: end-of-trial (1 month)
measure: Overall app rating for the conversational agent/chatbot app among patients and carers at the end of the trial (1 month).
timeFrame: end-of-trial (1 month)
measure: Usability of a conversational agent/chatbot among patients and carers at the end of the trial (1 month).
timeFrame: end-of-trial (1 month)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Nanyang Technological University, Center for Population Health Sciences, Lee Kong Chian School of Medicine
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: Liew Hui Ling, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.