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临床试验/NCT06607497
NCT06607497进行中(未招募)不适用

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

SingHealth Polyclinics2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2024年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
360
试验地点
2
主要终点
Risk Perception Survey-Diabetes Mellitus (RPS-DM)

研究概览

简要总结

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.

详细描述

Diabetes has emerged as a significant public health concern globally, and Singapore is no exception. As of 2022, 8.5% 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 5,646 per person) in 2010 to USD 1,867 million in 2050 (USD 7,791 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
36 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 Diabetes Mellitus on follow-up at the study site for at least 12 months
  • Age 36 to 65 years
  • At least one HbA1c reading ≥ 8.0% within the last 6 months
  • Able to read and speak English

排除标准

  • Not a Singapore citizen or permanent resident
  • End-stage kidney disease or on renal replacement therapy
  • Known terminal illness
  • Visual and/or hearing impairment
  • Cognitive impairment or mental illness
  • Unable to provide informed consent

研究组 & 干预措施

Arm 1

Experimental

In arm 1, participants will attend the risk communication session utilizing AI module (PERDICT.AI) delivered by the study team integrated with Home-based Diabetes Monitoring (PTEC-DM) providing personalized guidance through teleconsultation in addition to usual care. Screen activity of PERDICT.AI will be recorded using a screen capture software. The entire session will be audio recorded.

干预措施: Intervention using an AI enabled risk communication tool (PERDICT.AI) (Other)

Arm 1

Experimental

In arm 1, participants will attend the risk communication session utilizing AI module (PERDICT.AI) delivered by the study team integrated with Home-based Diabetes Monitoring (PTEC-DM) providing personalized guidance through teleconsultation in addition to usual care. Screen activity of PERDICT.AI will be recorded using a screen capture software. The entire session will be audio recorded.

干预措施: Telemonitoring with Primary Tech Enhanced Care (PTEC-DM) (Other)

Arm 2

Experimental

In arm 2, participants will attend the risk communication session utilising AI module (PERDICT.AI) without PTEC-DM. Screen activity of PERDICT.AI will be recorded using a screen capture software. The entire session will be audio recorded.

干预措施: Intervention using an AI enabled risk communication tool (PERDICT.AI) (Other)

Arm 3

No Intervention

Arm 3 will be the active control group, receiving only standard care

结局指标

主要结局

Risk Perception Survey-Diabetes Mellitus (RPS-DM)

时间窗: through study completion, an average of 12 to 16 months

The RPS-DM consists of 31 questions. The first section assesses risk knowledge (5 items scored on 3-point scale with 1 point for each correct answer; higher score indicates greater knowledge of the risk of getting diabetes complications). The remaining 26 items comprise 5 subscales which can be described as: perceived personal control (4 items scored on 4-point scale); worry (2 items scored on 4-point scale), optimistic bias (2 items scored on 4-point scale); personal disease risk (9 items scored on a 4-point scale; indicates degree of own perceived risk of getting 9 diseases or conditions, plus additional question about whether they have ever had the condition, scored yes/no with 1 point added for yes response); and environmental risk (9 items scored on a 4-point scale). The composite risk perception is the average of the 26 items in the main questionnaire; higher scores indicate greater comparative perceived risk.

Health related Quality of life

时间窗: through study completion, an average of 12 to 16 months

Change in the scores using EQ-5D-5L questionnaire; The EQ-5D-5L tool comprises five dimensions, each describing a different aspect of health: mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression. Each dimension has five response levels (no problems, slight problems, moderate problems, severe problems, unable to/ extreme problems). The proportion of patients reporting each level of problem on each dimension of the EQ-5D will be determined through study completion and compared. EQ VAS (Visual Analogue Scale) provides a quantitative measure of the patient's perception of their overall health. The EQ VAS records the respondent's overall current health on a vertical scale (0-100), where the endpoints are labelled '0-The worst health you can imagine' and '100-The best health you can imagine'.

Medication adherence

时间窗: through study completion, an average of 12 to 16 months

Change in the scores using five item Medication Adherence Report Scale (MARS-5); MARS-5 score was calculated by summing the numeric score (range 1-5) from each question for out of 25 (range 5-25). A higher score indicates better adherence.

Summary of Diabetes Self-care Activities (SDSCA) questionnaire

时间窗: through study completion, an average of 12 to 16 months

SDSCA questionnaire collects data on general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking, using an 8-point Likert-type scale (0-7), which represents the number of days per week when the given self-care activity was performed. Scores are calculated separately for each item and the level of adherence is indicated by the mean score for each dimension.

Iowa-Netherlands Comparison Orientation Measure (INCOM)

时间窗: baseline enrolment

The INCOM is an 11-item measure of one's tendency to make social comparisons. The scale includes such items as: "I always like to know what others in a similar situation would do." Response choices range from 1 (disagree strongly) to 5 (agree strongly). Higher scores indicate more of a tendency to socially compare.

次要结局

  • Cost-effectiveness analysis(through study completion, an average of 12 to 16 months)
  • Views and experiences of risk communication session using PERDICT.AI, PTEC-DM and usual care(24-48 weeks)
  • Exploring clinician' views on utility of combined intervention to improve risk perception(24-48 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tan Ngiap Chuan

Principal Investigator

SingHealth Polyclinics

研究点 (2)

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