Diabetes Footcare Companion App for Patients and Carers

January 18, 2024 updated by: Ho Hau Yan Andy, Nanyang Technological University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 308232
        • Nanyang Technological University, Center for Population Health Sciences, Lee Kong Chian School of Medicine
      • Singapore, Singapore, 308232
        • Tan Tock Seng Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with type 2 diabetes and their carer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other Names:
  • Well Feet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
end-of-trial (1 month)
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
end-of-trial (1 month)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Data on login frequency will be retrieved from the backend of the app at the end of trial.
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)
Data on total number of minutes spent on the app will be retrieved from the backend of the app at the end of trial.
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)
Data on total number of education module accessed will be retrieved from the backend of the app at the end of trial.
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)
Data on number of education module completed will be retrieved from the backend of the app at the end of trial.
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)
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.
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)
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.
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)
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.
end-of-trial (1 month)
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)
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.
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)
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.
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)
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.
baseline and 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)
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.
end-of-trial (1 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanyang Technological University

Collaborators

Tan Tock Seng Hospital
Ministry of Health, Singapore

Investigators

  • Principal Investigator: Liew Hui Ling, MBBS, Tan Tock Seng Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2023

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

September 29, 2022

First Submitted That Met QC Criteria

September 29, 2022

First Posted (Actual)

October 3, 2022

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NanyangTU_WellFeet

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient data will be anonymised and aggregated for analysis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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