Viewing Study NCT06607497



Ignite Creation Date: 2024-10-26 @ 3:40 PM
Last Modification Date: 2024-10-26 @ 3:40 PM
Study NCT ID: NCT06607497
Status: RECRUITING
Last Update Posted: None
First Post: 2024-09-16

Brief Title: Better Risk Perception Via Patient Similarity to Control Hyperglycemia and Sustained by Telemonitoring
Sponsor: None
Organization: None

Study Overview

Official Title: Better Risk Perception Via Patient Similarity to Control Hyperglycemia and Sustained by Telemonitoring
Status: RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: BRILLIANT
Brief 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 PERDICTAI 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 PERDICTAI 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 111 ratio to one of the three arms Arm 1 will receive risk communication session using PERDICTAI and home-based diabetes monitoring using PTEC-DM alongside usual care Arm 2 participants will undergo a standalone risk communication session using PERDICTAI 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 80 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
Detailed Description: Diabetes has emerged as a significant public health concern globally and Singapore is no exception As of 2022 85 of the adults in Singapore is affected by diabetes and the number is expected to reach 1 million by 2050 making it imperative to address the associated challenges The economic implications of diabetes extend beyond healthcare costs impacting productivity and quality of life The total cost among the working-age population with diabetes - direct and indirect costs included - is expected to rise from USD 787 million USD 5646 per person in 2010 to USD 1867 million in 2050 USD 7791 per person

In addition diabetes poses a substantial risk of complications that can adversely impact various organ systems Complications such as cardiovascular diseases neuropathy and retinopathy pose severe threats to the health of individuals with poorly managed diabetes A study on global trend of diabetes mortality revealed a concerning global increase in diabetes-related mortality particularly due to vascular complications posing a significant challenge to diabetes management To address the rising trends of mortality it is crucial to enhance awareness of diabetes complications to improve risk perception and ultimately reduce mortality rates

Perceived risk of diabetes complications can impact patient behavior influencing adherence to treatment plans and lifestyle changes Individuals with a higher risk perception may be more likely to engage in proactive management leading to better health outcomes and potentially reducing mortality rates associated with diabetes complications On the other hand individuals with poorer risk perception may neglect necessary precautions leading to suboptimal disease management and an increased likelihood of complications potentially impacting mortality rates

A systematic review on risk perceptions of diabetes complications highlights a concerning lack of awareness regarding the risk of diabetes related complications among individuals with type 2 diabetes mellitus T2DM Similarly research studies on diabetes complications risk awareness particularly in Singapore revealed knowledge gaps among adults Despite the significant impact on quality of life later-stage T2DM and its complications were perceived as slowly progressing and not immediately life-threatening Hence for poorly controlled diabetes patients effective communication regarding the risks of complications is paramount

Weaver et al defined risk communication as the effective and accurate exchange of information about health risks and hazards so as to advance risk awareness and understanding and promote health-protective behaviors Enhancing risk communication not only promotes informed decision-making but also advances early intervention and preventive measures Furthermore Hashim J et al emphasized the importance of considering social and cultural factors in the development of effective interventions among adults with elevated risk perception yet do not engage in preventive actions The study also suggested that diverse perspectives concerning the benefits and weaknesses related to preventive measures can impact the long-term sustainability of these behaviors

Risk communication interventions have been developed for patients with T2DM to improve their risk perceptions and health actions These interventional studies explore different methods to communicate diabetes complication risks to those with T2DM interventions include range of innovative risk communication methods like visual aids general nudges digital tool for personalized risk information and family support through WeChat While such interventions contribute to valuable insights there are some limitations with these tools like limited long-term impact technology adoption challenges Addressing these drawbacks with an integrated approach could enhance the robustness and applicability of the findings in diverse healthcare settings

PERDICTAI based counselling

An AI-enabled similarity-based model named PERDICTAI Personalised Diabetes Counselling Tool using Artificial Intelligence was developed by a team of primary care physicians and computer scientists in Singapore to help physicians communicate risks to patients with diabetes mellitus The tool ranks a patients HbA1c levels with similar patients or peers from a de-identified database showing how prevalent diabetes complications are based on HbA1c severity This is referred to as peer-comparison and the tool underwent revisions following feedback from primary care physicians to enhance its usefulness in risk communication

Based on Health Belief Model HBM a risk communication intervention was developed for Primary care Physicians PCPs to counsel patients with T2DM on their glycemic control and the complications that could arise and to recommend ways to improve glycemic control and prevent complications or further complications This will be supported by information from PERDICTAI

Risk communication using PERDICTAI dynamically communicates an individuals glycaemic 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

Diabetes management often requires consistent encouragement and guidance which a static risk communication tool may not deliver In addition passive receipt of information might not motivate patients to actively take part in diabetes management Such lack of engagement could lead to reduced adherence to recommended strategies limiting the tools overall impact This is evident from the RISK study where the improved risk perception observed initially at 2 weeks dissipated by the 12th week highlighting a temporal limitation in sustaining positive outcomes Although participants in the intervention arm reported higher satisfaction with risk communication this did not translate into sustained improvements This underscores the need for an integrated approach to sustain positive outcomes beyond short-term

Integration with telemonitoring system

Sustaining improved risk perception over an extended period can be achieved through telemonitoring By utilizing telemonitoring technology healthcare providers can maintain a consistent connection with patients offering real-time insights into their health status Additionally telemonitoring facilitates continuous education and support thereby contributing to the long-term sustainability of improved risk perception and can significantly enhance diabetes management and prevent complications

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

The integration of PTEC-DM with the risk communication using PERDICTAI capitalizes on the strengths of human interaction and adaptability contributing to a more holistic and patient-centred diabetes management approach Such combined approach addresses both monitoring and guidance contributing to enhanced patient understanding and informed decision-making Hence this study is designed with the following objectives adopting a multi-site multi-arm randomized controlled trial design

Objectives

Primary objective

i To assess the effectiveness of the risk communication using an AI enabled tool PERDICTAI in improving risk perception score quality of life and health outcomes medication adherence and selfcare activities and glycemic control among poorly controlled diabetes patients ii To determine the effectiveness of a combination of risk communication session using PERDICTAI and telemonitoring PTEC-DM in improving risk perception quality of life and health outcomes

Secondary objectives

iii To compare the impact of the two approaches in improving risk perception quality of life and health outcomes among poorly controlled diabetes patients iv To assess the cost-effectiveness of the advanced care by comparing the incremental costs and health outcomes v To explore participants views and experiences of risk communication session using PERDICTAI PTEC-DM and usual care vi To explore clinician views on utility of the new approach to improve risk perception

Hypothesis

There will be improvement in patients risk perception score and health outcomes glycemic control and self-care activities after the intervention

Materials and methods

Study setting The study will be conducted at 4 polyclinics from a primary care clinic cluster taking care of more than 200000 residents with diabetes in the Eastern region of Singapore

Study design Sequential explanatory mixed-method study

Quantitative Multi-arm randomized controlled trial RCT at four polyclinics which includes SingHealth Polyclinics at Pasir Ris Tampines North Eunos and Sengkang

Qualitative In-depth interview among the study participants and clinician who are integral part of the study team delivering interventions

Quantitative Multi-arm RCT This RCT involves three arms incorporating a combination of interventions and standard care as outlined below

Arm 1 Advanced care with risk communication using an AI enabled tool PERDICTAI home-based monitoring using PTEC DM main intervention arm Arm 2 Usual care risk communication using an AI enabled tool PERDICTAI Arm 3 Usual care All groups will also receive a diabetes pamphlet

Randomization Patient participants from each study site will be randomly allocated in a 111 ratio to one of the above-mentioned arms in an open-label fashion using computer-generated random numbers for simple randomization of subjects The nature of the intervention makes impossible to blind patients and research team to participant allocation The randomization sequence is written and kept in an opaque sealed envelope which will be labelled with a serial number The study team will open the sealed envelope once the patient has consented to participate and then will be assigned to the study arms accordingly All participants will receive a diabetes pamphlet Pamphlet - Taking Control of Diabetes

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None