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临床试验/NCT04832984
NCT04832984已完成不适用

Addressing Disparity in Diabetes Prevention Through Digital Health Supported PRe-diabetes Intervention, Management and Evaluation (PRIME) Program Based in Malaysian Community Pharmacies

Monash University2 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2022年3月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
91
试验地点
2
主要终点
Change in body weight

研究概览

简要总结

Currently, an estimated 3.9 million Malaysians continue to live with diabetes with many more who live with prediabetes. Diabetes was the one of the leading causes of death in the Malaysia and the leading cause for kidney failure, lower-limb amputations, and adult-onset blindness. Heart disease and stroke are two to four times more likely for individuals with diabetes. The use of mHealth or mobile health application can reduce blood sugar among individuals with prediabetes but also prevent a later occurrence of diabetes. In this study, the investigators aim to develop and evaluate the effectiveness of a digital health supported pre-diabetes management program based in an urban community pharmacy setting

详细描述

Pre-diabetes is an intermediate state of hyperglycaemia with glycaemic parameters above normal but below the type 2 diabetes mellitus (T2DM) threshold. It was estimated that >25% of individuals who are pre-diabetic convert to T2DM within 3-5 years and 70% of individuals with pre-diabetes will develop into full-fledge T2DM within their lifetimes. According to the 2017 estimate, the disease burden of pre-diabetes at Western Pacific region was 7.6% (126.7 millions). The situation is more alarming in Malaysia where a national pre-diabetes prevalence of 22.1% was noted. Currently available support and self-care services offered in Public Hospitals such as the Diabetes Mellitus Treatment Adherence Clinics (DMTAC) are managed based on the in-person appointment basis. Most of the clinics are available only in specific locations. The need to travel long distance as well as long waiting hours has deterred the success of the programs. This is particularly true for the urban poor who are less likely to take time off from work than those from the higher income group. It is also noteworthy to state that the management program when available, generally target the diagnosed T2DM patients.

Studies have shown that individuals with pre-diabetes can substantially reduce their risk of progression to T2DM via participation in evidence-based lifestyle change programs. Previous reports have recorded 54-58% reduction in risk for development to T2DM over 1-3 years with the protective benefit persisting up to 10 years following completion of the program. However, there are several considerations when implementing effective lifestyle intervention program among the pre-diabetes populations in Malaysia. The intervention program should easily be accessible and not confined to public primary and secondary healthcare centres which are already suffering from an overcapacity. Furthermore, consultation should be provided by properly trained healthcare professionals while the ease of communication between the patients and the "lifestyle coach" should be made available.

The advancement of information technology coupled with the increasing availability and acceptance of internet and mobile devices provide useful opportunities for application of wireless and mobile technology in order to enhance self-management of chronic conditions. The incorporation of digital technologies can improve patient adherence and facilitate real-time monitoring of vital biological measurements (i.e. via wearable). Additionally, the "mobile health" (mHealth) services are easily scalable, thus providing opportunities to a greater public accessibility and narrow the disparity in access to disease management. In this study, the investigators propose to pilot a digital health supported pre-diabetes management program based in an urban community pharmacy setting

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Cluster randomisation with blinding of statisticians

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 years and above
  • BMI 23 and above
  • HbA1c 5.7 - 6.4% or FPG 5.6mmol/L - 6.9mmol/L

排除标准

  • Unable to give informed consent
  • Pregnant or lactating
  • Established diabetes
  • Terminal illness
  • Does not own a mobile phone
  • Plans to relocate to an area or travel plans that do not permit full participation in the study

研究组 & 干预措施

Intervention arm

Experimental

Participants receiving the phone app together with a fitness tracker. All participants will receive the educational curriculum through the app over a period of 24 weeks. The mobile app allows secure patient monitoring through a participant dashboard that the coach can use to increase patient adherence and motivation to achieve goals. The participants can use the app to log their food intake, weight, steps, exercise, in addition to participating in the peer support via the chat function. Participants will also receive regular care and follow up in community pharmacies for support.

干预措施: Mobile health (Behavioral)

Usual care arm

Active Comparator

The control group will be a "usual care" condition in which participants are free to seek any assistance for their medical care during the study period. Participants will be given physical tracking sheets to record their food intake, weight, steps and exercises.

干预措施: Usual care (Behavioral)

结局指标

主要结局

Change in body weight

时间窗: Baseline, 1 month, 3 months, 6 months, 12 months

Weight Loss by % of change and total weight change (kg)

次要结局

  • Incidence of diabetes(12 months)
  • Change in anthropometry measures(Baseline, 1 month, 3 months, 6 months, 12 months)
  • Change in health related quality of life(Baseline, 1 month, 3 months, 6 months, 12 months)
  • Change in dietary practice(Baseline, 1 month, 3 months, 6 months, 12 months)
  • Change in cardiovascular risks(Baseline, 1 month, 3 months, 6 months, 12 months)
  • Change in hemoglobin A1c(Baseline, 3 months, 6 months, 12 months)
  • Change in physical activity(Baseline, 1 month, 3 months, 6 months, 12 months)

研究者

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

Shaun Lee Wen Huey

Associate Professor

Monash University Malaysia

研究点 (2)

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