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Diabetes Companion App for Adults With Diabetes and Their Carers

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2, Diabetes Mellitus

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
GLOW
Sponsored by
Nanyang Technological University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes focused on measuring Conversational Agent, Chatbot, Diabetes Literacy, Diabetes Knowledge, Self Management, Digital Therapeutics, Digital Health

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosed with type 2 diabetes and attending Tan Tock Seng Hospital (TTSH) Diabetes Clinic OR caring for a person with type 2 diabetes
  2. 21 years old or above
  3. Able to speak and read English
  4. Singapore nationality or permanent resident or foreign domestic worker (for carers)
  5. Own a personal mobile device which can download study mobile app
  6. Access to the internet

Exclusion Criteria:

  1. Are unable to consent;
  2. Are pregnant (for patients)
  3. Received formal training in medicine or allied health services

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Participants in the intervention group will use GLOW the conversational agent/app for 6 months in addition to their usual diabetes care offered by their attending doctor or endocrinologist.

The control group will continue with their usual care, i.e., scheduled consultations with their diabetes team at TTSH and any consultations with healthcare professionals and diabetes education support received either during the consultations or during dedicated times if there are any. They will not be asked to use GLOW during the trial.

Outcomes

Primary Outcome Measures

Changes in diabetes knowledge among patients and carers using Diabetes Knowledge Questionnaire at baseline, interim (3 months) and end-of-trial (6 months).
The changes in diabetes knowledge will be measured using the scores of a validated questionnaire, Diabetes Knowledge Questionnaire (DKQ).
Changes in diabetes knowledge among patients and carers in the intervention group using GLOW Quiz at baseline, interim (3 months) and end-of-trial (6 months).
The changes in diabetes knowledge among patients and carers in the intervention group will be measured using the scores of a new quiz developed based on GLOW modules, GLOW Quiz.

Secondary Outcome Measures

Changes in BMI among patients at baseline, interim (3 months) and end-of-trial (6 months).
BMI will be retrieved from patient's clinic records and recorded in kg/m^2.
Changes in waist circumference among patients at baseline, interim (3 months) and end-of-trial (6 months).
Waist circumference will be retrieved from patient's clinic records and recorded in cm.
Changes in glycemic controls measured by HbA1c among patients at baseline, interim (3 months) and end-of-trial (6 months).
HbA1c values will be retrieved from patient's clinic records and recorded in percentage.
Changes in fasting blood glucose levels among patients at baseline, interim (3 months) and end-of-trial (6 months).
Fasting blood glucose levels will be retrieved from patient's clinic records and recorded in mmol/L.
Changes in systolic and diastolic blood pressure among patients at baseline, interim (3 months), end-of-trial (6 months).
Systolic and diastolic blood pressure will be retrieved from patient's clinic records and recorded in mmHg.
Changes in serum high density lipoprotein (HDL) levels among patients at baseline, interim (3 months), end-of-trial (6 months).
High density lipoprotein (HDL) will be retrieved from patient's clinic records and recorded in mmol/L.
Changes in serum low density lipoprotein (LDL) levels among patients at baseline, interim (3 months), end-of-trial (6 months).
Low density lipoprotein (LDL) will be retrieved from patient's clinic records and recorded in mmol/L.
Changes in total cholesterol levels among patients at baseline, interim (3 months), end-of-trial (6 months).
Total cholesterol will be retrieved from patient's clinic records and recorded in mmol/L.
Changes in number of diabetes related hospitalization among patient at baseline, interim (3 months) and end-of-trial (6 months).
Data on hospitalization in term of frequency of hospitalization will be retrieved from patient's clinic records.
Changes in medical cost of diabetes related hospitalization among patient at baseline, interim (3 months) and end-of-trial (6 months).
Data on direct medical cost, direct non-medical cost and indirect cost will be collected in Singaporean Dollar (SGD) terms from patient's clinic records.
Changes in patients empowerment levels score using, Diabetes Empowerment Scale, at baseline, interim (3 months) and end-of-trial (6 months).
Score from a validated questionnaire, Diabetes Empowerment Scale, will be used to measure patient's empowerment levels.
Changes in patients attitude and behaviour score using Diabetes Intention, Attitude, and Behaviour Questionnaire (DIAB-Q), at baseline, interim (3 months) and end-of-trial (6 months).
Score from a validated questionnaire, Diabetes Intention, Attitude, and Behaviour Questionnaire (DIAB-Q), will be used to measure patient's attitude and behaviour towards diabetes.
Changes in patients and carers quality of life will be measured using EQ-5D-5L Questionnaire, at baseline, interim (3 months) and end-of-trial (6 months).
Score from a validated questionnaire, EQ-5D-5L Questionnaire, will be used to evaluate patients and carers quality of life.
Changes in caregiving levels among carers using Diabetes Caregiver Activity and Support Scale at baseline, interim (3 months) and end-of-trial (6 months).
Score from a validated questionnaire, Diabetes Caregiver Activity and Support Scale will be used to evaluate the carer's caregiving levels
Changes in caregiving burden among carers using Brief Assessment Scale for Caregivers at baseline, interim (3 months) and end-of-trial (6 months).
Scores from a validated questionnaire, Brief Assessment Scale for Caregivers, will be used to evaluate carer's perception and sense of burden.
GLOW App login frequency among patients and carers in the intervention group at will be measured the end-of-trial (6 months).
Data on app login frequency will be retrieved from the backend database of the app at the end-of trial.
GLOW App login period among patients and carers in the intervention group will be measured at the end-of-trial (6 months).
Data on app login period in term of "minutes spent in the app" will be retrieved from the backend database of the app at the end-of trial.
GLOW App module completion among patients and carers in the intervention group will be measured at the end-of-trial (6 months).
Data on "number of module started" and "number of module completed" will be retrieved from the backend database of the app at the end-of trial.
GLOW App usability perception among patients and carers in the intervention group will be measured at the end-of-trial (6 months).
Score from a validated questionnaire, MHealth App Usability Questionnaire will be used to evaluate usability of the app. This questionnaire will be built in the app and user will be requested to complete it at the end of the trial period. Data on the questionnaire scores will be retrieved from the backend database of the app at the end-of trial.

Full Information

First Posted
September 2, 2022
Last Updated
March 23, 2023
Sponsor
Nanyang Technological University
Collaborators
Tan Tock Seng Hospital, Ministry of Health, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT05535842
Brief Title
Diabetes Companion App for Adults With Diabetes and Their Carers
Official Title
Conversational Agent for Supporting People With Type 2 Diabetes and Their Carers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 28, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanyang Technological University
Collaborators
Tan Tock Seng Hospital, Ministry of Health, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Diabetes self-management support, education, and training are increasingly being delivered through digital technology such as mobile phones. This protocol aims to evaluate the effectiveness of GLOW, a diabetes companion app with a conversational agent.
Detailed Description
Adopting a healthier lifestyle and disease self-management skills is critical to reducing the risk of diabetes-related complications. Internationally, and in Singapore, the majority of people with diabetes report not having received structured diabetes education, while others have the knowledge and fail to apply it in their daily lives. Key self-management behaviours recommended by the American Association of Diabetes Educators include physical activity, healthy diet, blood glucose monitoring, and medication adherence, but equally important is healthy coping to maintain a positive attitude toward diabetes management. Life-long patient education and continuous empowerment are paramount to successful self-management in people with diabetes, as recommended by evidence-based diabetes management guidelines. In addition to patients, their informal carers often play an important role in the management of diabetes. As such, diabetes education for informal carers is essential to achieve the best possible diabetes outcomes in the patient. There are hundreds of diabetes apps available for the public to download and use, but few are rigorously evaluated for clinically meaningful outcomes. We designed GLOW, a diabetes companion app with a conversational agent, to support people with diabetes and their carers with self-management and knowledge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2, Diabetes Mellitus, Diabetes Type 2
Keywords
Conversational Agent, Chatbot, Diabetes Literacy, Diabetes Knowledge, Self Management, Digital Therapeutics, Digital Health

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
open-label, two-armed, randomized controlled trial
Masking
None (Open Label)
Masking Description
non-blinded
Allocation
Randomized
Enrollment
224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants in the intervention group will use GLOW the conversational agent/app for 6 months in addition to their usual diabetes care offered by their attending doctor or endocrinologist.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will continue with their usual care, i.e., scheduled consultations with their diabetes team at TTSH and any consultations with healthcare professionals and diabetes education support received either during the consultations or during dedicated times if there are any. They will not be asked to use GLOW during the trial.
Intervention Type
Other
Intervention Name(s)
GLOW
Other Intervention Name(s)
Mobile app, Conversational agent, Chatbot
Intervention Description
GLOW is an app for type 2 diabetes support and education that uses a conversational agent to help users develop self-management skills and learn about diabetes and healthy behaviours. This is achieved through a range of interactive strategies.
Primary Outcome Measure Information:
Title
Changes in diabetes knowledge among patients and carers using Diabetes Knowledge Questionnaire at baseline, interim (3 months) and end-of-trial (6 months).
Description
The changes in diabetes knowledge will be measured using the scores of a validated questionnaire, Diabetes Knowledge Questionnaire (DKQ).
Time Frame
baseline, interim (3 months), end-of-trial (6 months)
Title
Changes in diabetes knowledge among patients and carers in the intervention group using GLOW Quiz at baseline, interim (3 months) and end-of-trial (6 months).
Description
The changes in diabetes knowledge among patients and carers in the intervention group will be measured using the scores of a new quiz developed based on GLOW modules, GLOW Quiz.
Time Frame
baseline, interim (3 months), end-of-trial (6 months)
Secondary Outcome Measure Information:
Title
Changes in BMI among patients at baseline, interim (3 months) and end-of-trial (6 months).
Description
BMI will be retrieved from patient's clinic records and recorded in kg/m^2.
Time Frame
baseline, interim (3 months), end-of-trial (6 months)
Title
Changes in waist circumference among patients at baseline, interim (3 months) and end-of-trial (6 months).
Description
Waist circumference will be retrieved from patient's clinic records and recorded in cm.
Time Frame
baseline, interim (3 months), end-of-trial (6 months)
Title
Changes in glycemic controls measured by HbA1c among patients at baseline, interim (3 months) and end-of-trial (6 months).
Description
HbA1c values will be retrieved from patient's clinic records and recorded in percentage.
Time Frame
baseline, interim (3 months), end-of-trial (6 months)
Title
Changes in fasting blood glucose levels among patients at baseline, interim (3 months) and end-of-trial (6 months).
Description
Fasting blood glucose levels will be retrieved from patient's clinic records and recorded in mmol/L.
Time Frame
baseline, interim (3 months), end-of-trial (6 months)
Title
Changes in systolic and diastolic blood pressure among patients at baseline, interim (3 months), end-of-trial (6 months).
Description
Systolic and diastolic blood pressure will be retrieved from patient's clinic records and recorded in mmHg.
Time Frame
baseline, interim (3 months), end-of-trial (6 months)
Title
Changes in serum high density lipoprotein (HDL) levels among patients at baseline, interim (3 months), end-of-trial (6 months).
Description
High density lipoprotein (HDL) will be retrieved from patient's clinic records and recorded in mmol/L.
Time Frame
baseline, interim (3 months), end-of-trial (6 months)
Title
Changes in serum low density lipoprotein (LDL) levels among patients at baseline, interim (3 months), end-of-trial (6 months).
Description
Low density lipoprotein (LDL) will be retrieved from patient's clinic records and recorded in mmol/L.
Time Frame
baseline, interim (3 months), end-of-trial (6 months)
Title
Changes in total cholesterol levels among patients at baseline, interim (3 months), end-of-trial (6 months).
Description
Total cholesterol will be retrieved from patient's clinic records and recorded in mmol/L.
Time Frame
baseline, interim (3 months), end-of-trial (6 months)
Title
Changes in number of diabetes related hospitalization among patient at baseline, interim (3 months) and end-of-trial (6 months).
Description
Data on hospitalization in term of frequency of hospitalization will be retrieved from patient's clinic records.
Time Frame
baseline, interim (3 months), end-of-trial (6 months)
Title
Changes in medical cost of diabetes related hospitalization among patient at baseline, interim (3 months) and end-of-trial (6 months).
Description
Data on direct medical cost, direct non-medical cost and indirect cost will be collected in Singaporean Dollar (SGD) terms from patient's clinic records.
Time Frame
baseline, interim (3 months), end-of-trial (6 months)
Title
Changes in patients empowerment levels score using, Diabetes Empowerment Scale, at baseline, interim (3 months) and end-of-trial (6 months).
Description
Score from a validated questionnaire, Diabetes Empowerment Scale, will be used to measure patient's empowerment levels.
Time Frame
baseline, interim (3 months), end-of-trial (6 months)
Title
Changes in patients attitude and behaviour score using Diabetes Intention, Attitude, and Behaviour Questionnaire (DIAB-Q), at baseline, interim (3 months) and end-of-trial (6 months).
Description
Score from a validated questionnaire, Diabetes Intention, Attitude, and Behaviour Questionnaire (DIAB-Q), will be used to measure patient's attitude and behaviour towards diabetes.
Time Frame
baseline, interim (3 months), end-of-trial (6 months)
Title
Changes in patients and carers quality of life will be measured using EQ-5D-5L Questionnaire, at baseline, interim (3 months) and end-of-trial (6 months).
Description
Score from a validated questionnaire, EQ-5D-5L Questionnaire, will be used to evaluate patients and carers quality of life.
Time Frame
baseline, interim (3 months), end-of-trial (6 months)
Title
Changes in caregiving levels among carers using Diabetes Caregiver Activity and Support Scale at baseline, interim (3 months) and end-of-trial (6 months).
Description
Score from a validated questionnaire, Diabetes Caregiver Activity and Support Scale will be used to evaluate the carer's caregiving levels
Time Frame
baseline, interim (3 months), end-of-trial (6 months)
Title
Changes in caregiving burden among carers using Brief Assessment Scale for Caregivers at baseline, interim (3 months) and end-of-trial (6 months).
Description
Scores from a validated questionnaire, Brief Assessment Scale for Caregivers, will be used to evaluate carer's perception and sense of burden.
Time Frame
baseline, interim (3 months), end-of-trial (6 months)
Title
GLOW App login frequency among patients and carers in the intervention group at will be measured the end-of-trial (6 months).
Description
Data on app login frequency will be retrieved from the backend database of the app at the end-of trial.
Time Frame
end-of-trial (6 months)
Title
GLOW App login period among patients and carers in the intervention group will be measured at the end-of-trial (6 months).
Description
Data on app login period in term of "minutes spent in the app" will be retrieved from the backend database of the app at the end-of trial.
Time Frame
end-of-trial (6 months)
Title
GLOW App module completion among patients and carers in the intervention group will be measured at the end-of-trial (6 months).
Description
Data on "number of module started" and "number of module completed" will be retrieved from the backend database of the app at the end-of trial.
Time Frame
end-of-trial (6 months)
Title
GLOW App usability perception among patients and carers in the intervention group will be measured at the end-of-trial (6 months).
Description
Score from a validated questionnaire, MHealth App Usability Questionnaire will be used to evaluate usability of the app. This questionnaire will be built in the app and user will be requested to complete it at the end of the trial period. Data on the questionnaire scores will be retrieved from the backend database of the app at the end-of trial.
Time Frame
end-of-trial (6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with type 2 diabetes and attending Tan Tock Seng Hospital (TTSH) Diabetes Clinic OR caring for a person with type 2 diabetes 21 years old or above Able to speak and read English Singapore nationality or permanent resident or foreign domestic worker (for carers) Own a personal mobile device which can download study mobile app Access to the internet Exclusion Criteria: Are unable to consent; Are pregnant (for patients) Received formal training in medicine or allied health services
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Josip Car, MD PhD
Phone
(65) 6592 3960
Email
cephas_lkcmedicine@ntu.edu.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Daniel Azlan Mahadzir, PhD
Phone
(65) 6592 3943
Email
daniel.mahadzir@ntu.edu.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Ek Kwang Chew, MD
Organizational Affiliation
Tan Tock Seng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanyang Technological University, Center for Population Health Sciences, Lee Kong Chian School of Medicine
City
Singapore
ZIP/Postal Code
308232
Country
Singapore
Individual Site Status
Active, not recruiting
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Ek Kwang Chew, MD
Email
daniel.chew@ttsh.com.sg
First Name & Middle Initial & Last Name & Degree
Ying Qi Choong, MSc
Email
Ying_Qi_CHOONG@ttsh.com.sg
First Name & Middle Initial & Last Name & Degree
Daniel Ek Kwang Chew, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Patient data will be anonymized and analyzed on aggregated basis.

Learn more about this trial

Diabetes Companion App for Adults With Diabetes and Their Carers

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