RecruitingNot ApplicableNCT06607497

Better Risk Perception Via Patient Similarity to Control Hyperglycemia and Sustained by Telemonitoring

Sponsor

SingHealth Polyclinics

Enrollment

360 participants

Start Date

Jul 15, 2024

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 2

Summary

Background: Diabetes significantly raises the likelihood of complications, thereby increasing the risk of diabetes-related mortality, particularly due to vascular complications. It is vital to address this rising trend of mortality, by enhancing awareness of diabetes complications to improve risk perception and ultimately reduce mortality rates. Managing diabetes effectively requires interventions addressing both risk communication and monitoring, helping patients better understand and make informed decisions about their health. Objectives: The primary aim is to evaluate and compare the effectiveness of combined risk communication session using an AI module (PERDICT.AI) and home-based diabetes monitoring (PTEC-DM) versus a standalone risk communication session in improving health outcomes (risk perception, medication adherence, self-care activities and glycaemic control) among poorly controlled diabetes patients. Secondary aims are to explore participants' views and experiences of risk communication session using PERDICT.AI, PTEC-DM and usual care and clinician' views on utility of the new approach to improve risk perception. Methods: A mixed-method study design will be employed to conduct a multi-arm randomized controlled trial across four of the SingHealth Polyclinics cluster (Pasir Ris, Eunos, Sengkang, Tampines North). Patient participants will be randomly allocated in a 1:1:1 ratio to one of the three arms. Arm 1 will receive risk communication session using PERDICT.AI and home-based diabetes monitoring using PTEC-DM alongside usual care. Arm 2 participants will undergo a standalone risk communication session using PERDICT.AI with usual care while arm 3 will serve as the control group with usual care. A total of 360 (120 in each group) participants will be enrolled by simple randomization. Eligible patient must be of age between 36 and 65 years with HbA1c \>8.0% within the last 6 months. Significance of the study: Findings from the study may add evidence to the scientific knowledge of using these approaches to improve risk perception and recommend development of similar interventions.

Eligibility

Min Age: 36 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether showing people with poorly controlled type 2 diabetes how their health outcomes compare to similar patients can motivate them to better manage their blood sugar. It also uses remote monitoring to provide ongoing support. **You may be eligible if...** - You have type 2 diabetes and have been followed at the study clinic for at least 12 months - You are between 36 and 65 years old - Your HbA1c (a 3-month average blood sugar measure) has been 8.0% or higher at least once in the past 6 months - You are a Singapore citizen or permanent resident - You can read and speak English **You may NOT be eligible if...** - You are not a Singapore citizen or permanent resident - You are pregnant - You have end-stage kidney disease or are on dialysis - You have a terminal illness, vision or hearing impairment, or cognitive/mental illness - You cannot give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERIntervention using an AI enabled risk communication tool (PERDICT.AI)

Risk communication using PERDICT.AI dynamically communicates an individual's glycemic control, offering a comparative ranking among peers to enhance motivation and awareness. Furthermore, it assesses the risk of potential complications comparing with peer data with exemplary cases to underscore the consequences of suboptimal management. In addition, it will generate personalized recommendations including medication adjustment and personalized health plans.

OTHERTelemonitoring with Primary Tech Enhanced Care (PTEC-DM)

The Primary Tech-Enhanced Care (PTEC) programme focuses on encouraging patients to manage chronic conditions at home through user-friendly kits. The Home Diabetes Monitoring programme (PTEC-DM) enables home-based glucose and blood pressure monitoring once a week using a Bluetooth enabled device. These reading will be securely transmitted to the study team via the app and managed appropriately through teleconsultation. Additionally, participants will receive health nudges, encouragements, and reminders through in-app messages to support their well-being.