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

Sponsor

Lead Sponsor: Monash University

Collaboratore: Caring Pharmacy
Bionime Corporation
Tigas Pharma

Fonte Monash University
Breve riassunto

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

Descrizione dettagliata

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

Stato generale Not yet recruiting
Data d'inizio 2021-06-01
Data di completamento 2023-12-31
Data di completamento principale 2022-12-31
Fase N/A
Tipo di studio Interventional
Il risultato principale
Misurare Lasso di tempo
Change in body weight Baseline, 6 months, 12 months
Esito secondario
Misurare Lasso di tempo
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
Iscrizione 300
Condizione
Intervento

Tipo di intervento: Behavioral

Nome intervento: Mobile health

Descrizione: 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.

Etichetta del gruppo del braccio: Intervention arm

Tipo di intervento: Behavioral

Nome intervento: Usual care

Descrizione: 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

Etichetta del gruppo del braccio: Usual care arm

Eleggibilità

Criteri:

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

Genere: All

Età minima: 18 Years

Età massima: 99 Years

Volontari sani: No

Ufficiale generale
Contatto generale

Cognome: Chun Wie Chong, PhD

Telefono: 0355146688

E-mail: [email protected]

Posizione
Servizio, struttura: Shaun Lee
Paesi di posizione

Malaysia

Data di verifica

2021-04-01

Parte responsabile

Genere: Principal Investigator

Affiliazione dello sperimentatore: Monash University Malaysia

Nome completo dello sperimentatore: Shaun Lee Wen Huey

Titolo dello sperimentatore: Associate Professor

parole
Ha accesso esteso No
Condizione Sfoglia
Numero di armi 2
Braccio di gruppo

Etichetta: Intervention arm

Genere: Experimental

Descrizione: 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.

Etichetta: Usual care arm

Genere: Active Comparator

Descrizione: 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.

Dati del paziente Undecided
Informazioni sul design dello studio

Assegnazione: Randomized

Modello di intervento: Parallel Assignment

Scopo principale: Prevention

Mascheramento: Double (Participant, Outcomes Assessor)

Descrizione del mascheramento: Cluster randomisation with blinding of statisticians

Fonte: ClinicalTrials.gov

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