Prevention and Treatment of Diabetes in Adults

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

Patrocinadores

Patrocinador principal: Monash University

Colaborador: Caring Pharmacy
Bionime Corporation
Tigas Pharma

Fuente Monash University
Resumen breve

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

Descripción detallada

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

Estado general Not yet recruiting
Fecha de inicio 2021-06-01
Fecha de Terminación 2023-12-31
Fecha de finalización primaria 2022-12-31
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Change in body weight Baseline, 6 months, 12 months
Resultado secundario
Medida Periodo de tiempo
Incidence of diabetes 12 months
Change in hemoglobin A1c Baseline; 6 months; 12 months
Change in health related quality of life Baseline; 6 months; 12 months
Change in dietary practice Baseline; 6 months; 12 months
Change in physical activity Baseline; 6 months; 12 months
Inscripción 300
Condición
Intervención

Tipo de intervención: Behavioral

Nombre de intervención: Mobile health

Descripción: Participants will be issued a fitness tracker, Bluetooth enabled glucometer with a custom developed app which they can communicate digitally to the study investigators either as a group or individually. During the first week of the study, participants will be taught on how to use the program, how to interact with their coach, and the importance of maintaining motivation throughout the program. Participants will have access to a pharmacist-participant messaging, group messaging, daily challenges for behavior change, education articles (weekly bite-sized content over 24 weeks), food logging, steps and exercise logging, and feedback. They will be asked to log their weight, meals, and physical activity within the program on a weekly basis. Pharmacist will monitor participant progress through a web-based dashboard. Community pharmacist will be assisting users in setting specific, measurable, attainable, realistic, and time-based goals on a weekly basis.

Etiqueta de grupo de brazo: Intervention arm

Tipo de intervención: Behavioral

Nombre de intervención: Usual care

Descripción: Participants will be issued a fitness tracker and Bluetooth enabled glucometer but these functions will not be enabled or linked to any app..All participants will be sent paper version of educational materials but will not have access to a personal coaching but will be able to contact the pharmacist if needed

Etiqueta de grupo de brazo: Usual care arm

Elegibilidad

Criterios:

Inclusion Criteria: - High risk of developing diabetes according to a validated practice risk tool - Aged 18 years and above Exclusion Criteria: - 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

Género: All

Edad mínima: 18 Years

Edad máxima: 99 Years

Voluntarios Saludables: No

Oficial general
Contacto general

Apellido: Chun Wie Chong, PhD

Teléfono: 0355146688

Email: [email protected]

Ubicación
Instalaciones: Shaun Lee
Ubicacion Paises

Malaysia

Fecha de verificación

2021-04-01

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Monash University Malaysia

Nombre completo del investigador: Shaun Lee Wen Huey

Título del investigador: Associate Professor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Intervention arm

Tipo: Experimental

Descripción: Participants receiving the phone app together with a fitness tracker. All participants will receive the educational curriculum over a period of 12 weeks and then the post-core curriculum for 12 weeks through the app. 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 participant can log their food intake, weight, steps, exercise, in addition to participating in the peer support, and regular care and follow up in community pharmacies for support.

Etiqueta: Usual care arm

Tipo: Active Comparator

Descripción: 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 plus a paper version of the educational curriculum.

Datos del paciente Undecided
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Prevention

Enmascaramiento: Double (Participant, Outcomes Assessor)

Descripción de enmascaramiento: Cluster randomisation with blinding of statisticians

Fuente: ClinicalTrials.gov

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