Clinical trial NCT05535842: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Diabetes Mellitus, Type 2
Diabetes Mellitus
Diabetes Type 2
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: 2022-09-10
Enrollment: 224
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open-label, two-armed, randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

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