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Clinical Trials/NCT05535842
NCT05535842
Recruiting
Not Applicable

Conversational Agent for Supporting People With Type 2 Diabetes and Their Carers

Nanyang Technological University2 sites in 1 country224 target enrollmentNovember 28, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes
Sponsor
Nanyang Technological University
Enrollment
224
Locations
2
Primary Endpoint
Changes in diabetes knowledge among patients and carers using Diabetes Knowledge Questionnaire at baseline, interim (3 months) and end-of-trial (6 months).
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 28, 2022
End Date
September 30, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Josip Car

Director, Center for Population Health Sciences, Lee Kong Chian School of Medicine

Nanyang Technological University

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

Outcomes

Primary Outcomes

Changes in diabetes knowledge among patients and carers using Diabetes Knowledge Questionnaire at baseline, interim (3 months) and end-of-trial (6 months).

Time Frame: baseline, interim (3 months), 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).

Time Frame: baseline, interim (3 months), 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 Outcomes

  • Changes in BMI among patients at baseline, interim (3 months) and end-of-trial (6 months).(baseline, interim (3 months), end-of-trial (6 months))
  • Changes in waist circumference among patients at baseline, interim (3 months) and end-of-trial (6 months).(baseline, interim (3 months), end-of-trial (6 months))
  • Changes in glycemic controls measured by HbA1c among patients at baseline, interim (3 months) and end-of-trial (6 months).(baseline, interim (3 months), end-of-trial (6 months))
  • Changes in fasting blood glucose levels among patients at baseline, interim (3 months) and end-of-trial (6 months).(baseline, interim (3 months), end-of-trial (6 months))
  • Changes in systolic and diastolic blood pressure among patients at baseline, interim (3 months), end-of-trial (6 months).(baseline, interim (3 months), end-of-trial (6 months))
  • Changes in serum high density lipoprotein (HDL) levels among patients at baseline, interim (3 months), end-of-trial (6 months).(baseline, interim (3 months), end-of-trial (6 months))
  • Changes in serum low density lipoprotein (LDL) levels among patients at baseline, interim (3 months), end-of-trial (6 months).(baseline, interim (3 months), end-of-trial (6 months))
  • Changes in total cholesterol levels among patients at baseline, interim (3 months), end-of-trial (6 months).(baseline, interim (3 months), end-of-trial (6 months))
  • Changes in number of diabetes related hospitalization among patient at baseline, interim (3 months) and end-of-trial (6 months).(baseline, interim (3 months), end-of-trial (6 months))
  • Changes in medical cost of diabetes related hospitalization among patient at baseline, interim (3 months) and end-of-trial (6 months).(baseline, interim (3 months), end-of-trial (6 months))
  • Changes in patients empowerment levels score using, Diabetes Empowerment Scale, at baseline, interim (3 months) and end-of-trial (6 months).(baseline, interim (3 months), end-of-trial (6 months))
  • 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).(baseline, interim (3 months), end-of-trial (6 months))
  • GLOW App login period among patients and carers in the intervention group will be measured at the end-of-trial (6 months).(end-of-trial (6 months))
  • GLOW App module completion among patients and carers in the intervention group will be measured at the end-of-trial (6 months).(end-of-trial (6 months))
  • GLOW App usability perception among patients and carers in the intervention group will be measured at the end-of-trial (6 months).(end-of-trial (6 months))
  • 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).(baseline, interim (3 months), end-of-trial (6 months))
  • Changes in caregiving levels among carers using Diabetes Caregiver Activity and Support Scale at baseline, interim (3 months) and end-of-trial (6 months).(baseline, interim (3 months), end-of-trial (6 months))
  • Changes in caregiving burden among carers using Brief Assessment Scale for Caregivers at baseline, interim (3 months) and end-of-trial (6 months).(baseline, interim (3 months), end-of-trial (6 months))
  • GLOW App login frequency among patients and carers in the intervention group at will be measured the end-of-trial (6 months).(end-of-trial (6 months))

Study Sites (2)

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