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Abstract
Introduction Pre-diabetes indicates an elevated risk of developing type-2 diabetes and presents a window for preventive actions. The Pre-diabetes Intervention, Management and Evaluation (PRIME) programme is a community pharmacy-based pre-diabetes management programme that uses a mobile application for self-monitoring and pre-diabetes education, aiming to promote lifestyle changes among participants with pre-diabetes.
Methods and analysis This is a protocol for a cluster randomised controlled trial that aims to evaluate the impact of the PRIME programme on participants’ clinical outcomes and explore participants’ and pharmacists’ views towards its implementation. This protocol describes the development of the PRIME programme and mobile app, its feasibility and implementation in community pharmacy settings. 16 pharmacies from two states in Malaysia will be randomised to the intervention arm or standard care. The study will include overweight or obese adults with pre-diabetes. During each follow-up visit at the pharmacy, intervention participants will receive in-depth counselling from pharmacists after reviewing their self-monitoring data recorded in the PRIME app. They will also receive pre-diabetes education through the app and join a peer support chatgroup. The primary clinical outcome includes changes in body weight at 6 months, while the secondary clinical outcomes include changes in blood glucose profile, lipid profile, blood pressure and adiposity measures. The sustainability of the PRIME programme will be accessed using a follow-up questionnaire, while participants’ engagement with the intervention will be evaluated using attendance rate and the app data. Focus group discussions and one-to-one interviews will be conducted for process evaluation. This study will inform the impact of community pharmacists-led digital health intervention in pre-diabetes management.
Ethics and dissemination This study has been registered with clinicaltrials.gov (NCT04832984) and approved by the Monash University Human Research Ethics Committee (Project ID: 27512).
Trial registration number clinicaltrials.gov (NCT04832984).
- Clinical trials
- Diabetes & Endocrinology
- Epidemiology
- Primary Prevention
- eHealth
- Behaviour
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STRENGTH AND LIMITATIONS OF THIS STUDY
This is the first study that examines the real-world impact of incorporating a mobile app and using the role of community pharmacists to deliver a pre-diabetes management programme.
Stakeholders and members of the public will be involved during the development process of the intervention.
This protocol will comprehensively detail the development process, feasibility and implementation of the interventions, as well as evaluation of the clinical and behavioural outcomes of the Pre-diabetes Intervention, Management and Evaluation (PRIME) programme.
This study will not specifically identify participants with impaired glucose tolerance, as administering oral-glucose tolerance tests is not feasible in a community pharmacy setting.
Introduction
Type-2 diabetes (T2D) is a global health emergency affecting 537 million people worldwide.1 2 While most people newly diagnosed with T2D are typically aged 55 years and older, the increasing number of people with early-onset T2D is posing a new public health challenge.3 4 Consensus guidelines recommend that high-risk individuals, including those who are overweight or obese, those with a previous history of gestational diabetes, strong family history of T2D and ethnic groups susceptible to T2D, be screened for diabetes and pre-diabetes.2 Pre-diabetes is presented as impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) and is a condition when an individual’s blood glucose levels rise above normal without exceeding the diabetes threshold. A fasting blood glucose reading of 5.6–6.9 mmol/L (IFG), 2- hour post-load glucose of 7.8–11.0 mmol/L (IGT) and/or elevated glycated haemoglobin (HbA1c) of 5.7%–6.4% is consistent with pre-diabetes, with values above these thresholds indicative of diabetes.2
One in 10 people with IGT develops T2D yearly, with a lifetime risk of 70%.5 This high-risk progression to T2D is an alarming sign that calls for concerted preventive efforts. Interventions that target pathophysiological factors, such as those that reduce weight, promote a balanced diet and increase physical activity, provide more sustainable and longer-term benefits than using antidiabetic medications.6–10 For example, the Diabetes Prevention Program,6 7 the Finnish Diabetes Prevention Study8 and the Da Qing study9 reduced the risk of progression to T2D by up to 58% over 3 years, with the protective benefit persisting for up to 10 years.7 11 12 The implementation of lifestyle interventions in these studies prevented diabetes related-complications and prolonged life.13 With the advent of new technologies, many of these interventions are now supported through digital health platforms.14–16
Malaysia has one of the highest rates of obesity and T2D in Southeast Asia.17 18 With nearly 3.9 million Malaysians diagnosed with diabetes, effective interventions are needed to alleviate the burden of T2D.17 The Diabetes Medication Therapy Adherence Clinic (DMTAC), a pharmacists-led diabetes management service was introduced since the year 2006 in appointed government-funded healthcare facilities in Malaysia. By emphasising on diabetes education and medication adherence, patients enrolled on the DMTAC service showed improved glycaemic control.19–21 Currently, the DMTAC service in Malaysia is focused on supporting individuals with diabetes, highlighting opportunities for preventive actions through initiatives in pre-diabetes management.22
Community pharmacy services are increasingly involved in health promotion, disease prevention and management activities.23 In the USA, guidelines have been developed for pre-diabetes screening and diabetes prevention to be carried out by community pharmacies.24 Although community pharmacists in Malaysia participate in health promotion activities such as weight management, diabetes counselling and lifestyle counselling, they remain largely underused in campaigns to prevent diabetes.25 Evidence on the effectiveness of using community pharmacies to deliver pre-diabetes management programmes in Malaysia, however, remains limited. Community pharmacies in Malaysia are more readily available than public health clinics and hospitals26 and are the first point of access to healthcare for vulnerable groups who do not consult regularly with a general practitioner, diabetes educator or other healthcare professionals.27 28 Therefore, a community pharmacy-based pre-diabetes intervention could potentially complement with the other diabetes prevention strategies.
Recognising this gap, we developed a digital health-supported pre-diabetes management programme based in community pharmacies. The Pre-diabetes Intervention, Management and Evaluation (PRIME) programme is a partnership between Monash University and Malaysian community pharmacies working to prevent T2D. The PRIME programme uses a mobile-based application to promote weight loss and modify risk factors in people with pre-diabetes. It delivers a structured curriculum to educate people with pre-diabetes on their condition, with community pharmacists providing support as pre-diabetes health coaches.
Objectives
The primary objective of this study is to evaluate the effects of a digital health-supported and community pharmacy-based pre-diabetes management programme on individuals with pre-diabetes in Malaysia. In addition, this study also aims to explore the participants’ and pharmacists’ experiences and perceptions regarding the implementation, adoption and participation of the PRIME programme.
Methods and analysis
This protocol is designed and reported according to the Standard Protocol Items: Recommendations for Interventional Trials checklist (online supplemental material figure S1).29
Supplemental material
Analysis framework
The development of the PRIME programme study is underpinned by the Framework for Developing and Evaluating Complex Interventions jointly commissioned by the Medical Research Council and the National Institute for Health Research (MRC-NIHR) (figure 1).30
Framework for developing and evaluating complex interventions reproduced with permission from Skivington et al.29
This framework describes how complex interventions can be divided into four non-sequential phases: developing or identifying an intervention, feasibility, evaluation and implementation. The framework emphasises six core elements at each phase, which consist of the context where the intervention will be delivered, testing and refining programme theory, involving important stakeholders, identifying key uncertainties, refining intervention and economic considerations. This paper will describe the development of the current study using the MRC-NIHR framework.30
Development of intervention
Theoretical framework
The programme will use the principles of the Behaviour Change Wheel as the foundation of this study.31 Based on the framework, the PRIME programme will be designed by targeting four main intervention functions on pre-diabetes management, namely: ‘education’, ‘training’, ‘enablement’ and ‘persuasion’. These were key areas that could facilitate lifestyle behavioural change and the implementation of a pre-diabetes management programme based on a previous review.32 A brief explanation and examples of how these barriers will be addressed by components of the PRIME programme are shown in table 1.
Examples of how PRIME components are applied as each intervention functions based on the BCW
Stakeholders engagement
The PRIME programme will be codesigned by the research team from the School of Pharmacy and the School of Information Technology from Monash University Malaysia, healthcare professionals, and members of the public. Inputs from healthcare professionals (endocrinologists, community pharmacists, nutritionists and dietitians), and members of the public will be collected and used to refine the PRIME programme and its mobile application throughout the development process.
Patient and public involvement
Members of the public will be involved during the mobile app and intervention development process of the study. Interview sessions with members of the public will be conducted, where they preview a prototype of the PRIME app to provide insights on its feasibility for a community pharmacy-based digital health-supported pre-diabetes management programme. During the interviews, participants will provide feedback on their acceptance towards the burden of the intervention (eg, frequencies of blood glucose monitoring) and the time required to participate in the study. User acceptance tests of the PRIME mobile app will also be conducted with the general public before the implementation of the PRIME programme.
Phase 1: feasibility
User acceptance tests
The prototype of the PRIME app will be tested on the users from the general public. Participants will be asked to install the PRIME app on their mobile phones and complete a set of tasks using the features available within the app. Feedback will be collected from each participant via a user feedback survey that used Likert scales and open-ended questions to assess user experience, acceptability and usability of the app.
Pilot study
In line with the MRC guidance, a month-long pilot study will be carried out. The pilot study will be conducted with the aim of testing the feasibility of the PRIME programme at two community pharmacies. The recruitment strategies, data collection procedures, time taken, pharmacists’ capacity to deliver the intervention, adherence, retention and app engagement and participants’ feedback will be assessed and used to optimise the study design.
Phase 2: implementation
Study design and setting
The PRIME programme is designed as a pragmatic digital health-supported pre-diabetes cluster randomised controlled study that will be delivered through community pharmacies. 16 community pharmacies from Selangor and Kuala Lumpur will be randomised to either the intervention arm or standard care. The locations of the community pharmacies can be found in online supplemental material figure S2). Community pharmacies will be selected to participate if they (1) have at least a locally registered pharmacist willing to participate and (2) have suitable facilities available for pharmacist counselling, point-of-care tests, body weight and other anthropometry measurements.
Sample size calculation
Based on a previous pre-diabetes intervention study, it was reported that 8% of individuals in the usual care group and 35% in the intervention group achieved a 5% weight loss at 6 months.14 Assuming an intracluster correlation coefficient of 0.007,33 a design effect of 1.035, a power of 80% and alpha of 5%, a total of 72 participants will need to be recruited. After accounting for a 25% loss to follow-up in each arm, a total of 90 participants will be recruited across at least 14 community pharmacies. Figure 2 shows the study flowchart.
Flowchart of the PRIME study. PRIME, Pre-diabetes Intervention, Management and Evaluation
Recruitment strategies
To identify potential participants, we plan to conduct pre-diabetes awareness campaigns and blood glucose screening activities at community centres, community pharmacies and workplaces. Promotional materials such as posters and brochures will be placed in community pharmacies, and the programme will be advertised through social media platforms. Participants may also be self-referred.
The first author, KWT, and a research assistant (RA) will explain the trial purposes and procedures to eligible prospective participants who fulfilled the inclusion criteria (table 2) and provide them with a written explanatory statement. KWT and RA will collect written consent forms from the participants who have decided to join the study, and all consented participants will undergo four face-to-face visits across 6 months with their pharmacists at the pharmacy. However, they are free to withdraw from the study at any time during the study period. The schedule of enrolment, interventions and assessment is outlined in figure 3 and the flowchart of screening, recruitment and follow-up visit processes is detailed in figure 4.
Inclusion and exclusion criteria of PRIME programme
Schedule of enrolment, interventions and assessments for PRIME programme.t1, baseline; t2, 1-month visit; t3, 3-month visit; t4, 6-month follow-up visit; t5, 9-month follow-up questionnaire. BMI, body mass index; FBG, fasting blood glucose; HbA1c, glycated haemoglobin A1c; TC, total cholesterol; TG, triglycerides; LDL, low-density lipoprotein; HDL, high-density lipoprotein; IPAQ, International Physical Activity Questionnaire; HADS, Hospital Anxiety and Depression Score; BIPQ, Brief Illness Perception Questionnaire; PRIME, Pre-diabetes Intervention, Management and Evaluation; PSQI, Pittsburgh Sleep Quality Index.
Flowchart of PRIME screening, recruitment and follow-up. BMI, body mass index; FBG, fasting blood glucose; HbA1c, glycated haemoglobin A1c; PRIME, Pre-diabetes Intervention, Management and Evaluation.*For participants in the intervention group only. Those in the control group may receive advice as per pharmacist’s usual practice, which typically includes simple advice on lifestyle changes.
Randomisation and blinding
In this study, a cluster-randomised design will be adopted where randomisation will occur at the community pharmacy level instead of the individual level. This is to prevent any potential cross-contamination, especially in the event two individuals receiving different interventions may visit the same community pharmacy at the same time.
Using a web-based randomisation tool,34 the 16 participating community pharmacies will be stratified based on their geographical areas and randomised to either the intervention or control groups (1:1). Participants who are recruited through other channels other than from pharmacy screenings (eg, health campaigns at community centres) will be given a list of participating community pharmacies to choose from for their baseline visit and subsequent follow-ups. The participants will be blinded from the groups that the community pharmacies are randomised into, and will only be informed of their allocation at the end of the study. Given the nature of the intervention, community pharmacists will not be blinded.
Pharmacist coaching
Before the study commencement, all community pharmacists who will be involved in the study will undergo a 3-hour online coaching session conducted by the research implementation team comprising of the PRIME Programme Pharmacist and PRIME Programme Nutritionist. The pharmacists will be coached on lifestyle counselling points and techniques, given a demonstration of the PRIME app and briefed on the operation procedures of the PRIME programme at the pharmacy.
Treatment
At the baseline visit, both control and intervention groups will be provided a glucometer (Bionime GE Max Plus, Taiwan) and a fitness tracker (XiaoMi Miband 6, China) for self-monitoring of their blood glucose and physical activity levels.
Both arms will be introduced to the PRIME app that includes the core features for self-monitoring of physical activities, weight, blood glucose levels and food intake. All participants will be required to download the PRIME app and be taught how to self-monitor their health parameters using the app. Participants’ blood glucose readings, step counts, hours of sleep and food intake will also be synchronised and recorded in the PRIME app. These data will then be portrayed in real-time on the PRIME dashboard and be accessible to the community pharmacists at the pharmacies. The PRIME app will also automatically set an individualised daily calorie allowance for each participant, calculated based on participants’ age, body weight, height, gender and physical activity level. A total of 500 kcal will be deducted from each participant’s daily calorie intake goals to encourage weight loss.35
As part of the programme, participants will also meet their community pharmacist at baseline, 1 month, 3 months and 6 months, which will be scheduled in advance with the PRIME pharmacist. At each visit, the participants will be encouraged to practise the healthy plate model and engage in 150 min of moderate-intensity exercises each week. After the 6-month visit, participants will no longer have to attend the face-to-face visits. To determine whether participants are able to sustain the lifestyle changes they developed throughout the PRIME programme, a researcher will conduct a follow-up questionnaire at 9 months. This questionnaire will examine their current lifestyle practices, self-monitoring habits, and engagement with the PRIME app.
Intervention arm
Participants in the intervention group will be provided with 14 in-app pre-diabetes education modules comprising of infographics, videos and quizzes (online supplemental material figure S3). A team of nutritionists, dietitians and pharmacists derive the content of the education modules based on the findings of a mixed-method cross-sectional study that was conducted to understand the public needs on pre-diabetes knowledge and lifestyle management. These modules will provide education on the pathophysiology and complications of pre-diabetes, and information on healthy food choices, physical activities, importance of sleep and stress management, and the detrimental effect of smoking. The modules will be designed to stimulate positive and negative feelings among participants and to stimulate behavioural actions. For example, photos of delicious healthy meals with vivid colours will be displayed.
The participants will also be invited to join a peer support chatgroup, which will serve as a platform for participants to share their experiences, such as successful lifestyle modification, as well as to help address any difficulties and encourage one another. Before obtaining consents, all concerns will be addressed and participants will be briefed on the rules and the purpose of the chatgroups. Those who consent will be organised into centralised groups of 10 in the order of their enrolment. The chatgroups will be hosted on WhatsApp and will be moderated by a core team of PRIME personnel, including a PRIME pharmacist and a PRIME nutritionist. The PRIME personnel will use the chatgroup to disseminate any additional pre-diabetes-related information and motivational messages on a bi-weekly basis. They will also monitor the discussion and address any questions as they arise. In cases where misinformation and inappropriate behaviour arise, the PRIME personnel will discuss the issue to reach a consensus on the best course of action.
At each scheduled face-to-face visit, the community pharmacists will provide in-depth lifestyle counselling focusing on lifestyle changes in the areas of diet, exercise, sleep and stress based on each participant’s self-monitoring records as portrayed on the PRIME dashboard. The pharmacists will also work with the participants to set SMART (Specific, Measurable, Realistic, Achievable and Timely) goals during each visit, by choosing small changes that are thought achievable by the participants in their daily lives. For example, as the participants work towards the goal of achieving 10 000 step counts per day by the end of 6 months, they should inform their pharmacists of their plans to increase their step count targets based on their current capabilities. Table 3 shows the different elements delivered in the control and intervention groups.
Difference between control and intervention group
Control arm
Similar to the intervention arm, participants in the control arm will be provided with the PRIME app which will enable them to track their blood glucose, physical activities, weight and food intake. However, they will not have access to the in-app educational modules and peer support. They will be counselled on lifestyle changes based on the participating pharmacy’s usual practice, which typically includes simple advice on lifestyle changes.
Evaluation
Primary objective
The primary objective of this study is to evaluate the impact of the PRIME programme on the clinical outcomes of the participants. The data collection forms for primary and secondary clinical outcome measures of the PRIME programme can be found in online supplemental material figure S4). The clinical outcome measures are described below:
Primary clinical outcome
Changes in body weight
Evidence from studies has shown that modest weight loss is highly associated with a lower risk of developing diabetes.36 The Finnish Diabetes Study found that a 5% weight loss was associated with a 70% reduction in diabetes incidence compared with those who did not achieve at least 5% weight loss.8 Similarly, several consensus guidelines defined 5% weight reduction as clinically meaningful due to its association with better cardiovascular outcomes, including glycaemic control.35 37 Therefore, weight change at 6 months is chosen as the primary outcome of the study, defined by (1) the percentage of participants achieving ≥5% reduction in body weight and (2) differential change in weight loss between the intervention and control group.
Secondary clinical and non-clinical outcomes
Blood glucose parameters (HbA1c, FBG)
Among the three main blood glucose tests recommended by the American Diabetes Association (ADA) guidelines to define pre-diabetes, HbA1c and FBG are chosen as secondary clinical outcomes as it is not feasible to conduct oral-glucose tolerance test (OGTT) in a community pharmacy. An improvement in blood glucose parameters, including HbA1c and FBG, has been shown in diabetes prevention studies involving lifestyle interventions.7 8 Both HbA1c and FBG will be measured using point-of-care test devices which will be calibrated to ensure comparability. HbA1c tests will be tested every 3 months during participant visits at the pharmacy, while FBG will be monitored through participants’ self-monitoring record using a glucometer.
Lipid profile and blood pressure
The ADA guidelines recommend close monitoring of cardiovascular risks among adults with pre-diabetes who are overweight or obese,38 as these individuals have increased cardiovascular risks including hypertension and dyslipidaemia.39 In addition, several lifestyle intervention studies reported improved cardiometabolic outcomes among people with prediabetes postintervention.40 The participants’ lipid profile will be monitored at baseline and 6 months. Blood pressure readings will be collected at baseline, 1 month, 3 months and 6 months. To ensure consistency, all blood pressure measurements will be taken from the right arm with the midpoint of the cuff aligned with the heart level.41 Three blood pressure recordings will be obtained from the participant in a sitting position after 3 min of silent rest, at 1 min intervals, and then the mean value for all three readings will be calculated.41 42 The pharmacist will remain silent in the room with the participants during the blood pressure checks to monitor the procedure and ensure accuracy.
Adiposity measures (body mass index (BMI), waist circumference, waist-to-hip ratio, body composition)
Adiposity is closely associated with insulin resistance. Measures of obesity and central obesity such as body fat percentage, BMI, waist circumference and waist-to-hip ratio predict the risk of T2D.43–45 Body composition, including body fat percentage, body water percentage, muscle mass index, visceral fat and lean body weight will be measured using a bioelectrical impedance analysis machine (Novoplus Intellyz, Malaysia). Waist circumference will be measured with a soft tape on standing participants, mid-way between the lowest rib and iliac crest to the nearest 0.1 cm. Hip circumference will be measured over the widest part of the gluteal region, and the waist-to-hip ratio calculated.
Behaviour changes (diet, physical activities, sleep, illness perception, psychological outcomes)
To measure the impact of PRIME programme towards lifestyle behaviour change, several questionnaires will be administered to the participants:
Alongside the step counts data from the PRIME app, the International Physical Activity Questionnaire46 (IPAQ) will be administered to participants at baseline, 1 month, 3 months and 6 months to gather information on their physical activities.
EuroQol-5 Dimension-5 Level47 (EQ-5D-5L) questionnaires will be administered at baseline, 1 month, 3 months and 6 months to assess participants’ health-related quality of life.
Hospital Anxiety and Depression Scores48 (HADS) and Brief Illness Perception Scores (BIPQ)49 will be administered at baseline, 3 months and 6 months to inform participants’ psychosocial changes over the duration of the PRIME programme.
Pittsburgh Sleep Quality Index50 (PSQI) will be administered at baseline and 6 months to assess participants’ sleep habits. The sleep data collected from their PRIME app will also be used to assess changes in sleep duration.
Multiple 24-hour dietary recall (3 days) will be used to detect changes in dietary habits in participants at baseline and 6 months of the study.
Sustainability and durability of weight loss and lifestyle changes
Participants who have completed the PRIME programme will be approached via text messages or phone call to complete an online follow-up questionnaire. Information on self-reported weight, current lifestyle habits and PRIME app usage will be collected to determine the sustainability of the clinical outcomes achieved through the PRIME programme.
Engagement with intervention
The level of participant engagement with the intervention will be measured based on attendance rate at pharmacy visits and interaction metrics from the PRIME mobile app. Data on app usage will be retrieved from the PRIME app, including frequency of blood glucose monitoring, food diary entries, sleep tracking and completion rates of education modules and quiz scores. In addition, the relationship between participant engagement levels and the primary outcome will be assessed. All results on engagement will be summarised descriptively.
Secondary objectives
Process evaluation
In line with the MRC framework, the process evaluation captures whether the PRIME programme is delivered as designed, the changes produced by the PRIME programme, and contextual factors that affect the implementation and outcomes of the study.51
Focus group discussions and individual qualitative interviews will be conducted with the participants and pharmacists of each study arm after the conclusion of the PRIME programme. The focus groups and interviews will be held at times convenient to the participants and will last approximately one to one and a half hours. Each focus group session will consist of not more than eight consenting participants. A semistructured topic guide using open-ended questions will be used to elicit participation. The topic guide will focus on three main areas: their experience participating in the PRIME programme, using digital health tools for self-management and peer support and using community pharmacy service for pre-diabetes care. The moderator will facilitate the participants’ answers, keeping the discussion on the topics under consideration, but will otherwise be non-directive, supportive and non-evaluative. All interviews will be audiotaped for transcription and analysis.
Data analysis
This study analysis will be conducted using the intention-to-treat approach. All participants randomised into the study will be included in the analysis regardless of their compliance to the study protocol. In the event of missing data, multiple imputations will be used to generate 20 imputed datasets. To account for the cluster effect, mixed effect modelling will be used to compare the changes in primary and secondary outcomes between both groups. Clusters (pharmacies) will be included as random effect and confounders will be controlled. The differential change between the two groups, odd ratio, and proportion of participants losing ≥5% weight will be presented along with corresponding 95% CIs. In addition, sensitivity analyses will be conducted for the primary outcome using unadjusted per-protocol data, adjusted per-protocol data and adjusted and imputed data. All baseline characteristics will be summarised using descriptive statistics.
Qualitative data from the focus group discussions and individual interviews will be analysed using content analysis techniques to determine the participants’ perceptions and contextual feasibility.
Confidentiality
The collected data will be deidentified and labelled with codes assigned by KWT. All participants’ data will only be accessible to the research team members. The pharmacists at the participating community pharmacies will only be able to access information of the participants from their respective pharmacies. Only the study investigators will have access to the final dataset.
Ethics and dissemination
This study has been registered with clinicaltrials.gov (NCT04832984) and approved by the Monash University Human Research Ethics Committee (MUHREC) (Project ID: 27512). Any substantial amendments to the protocol will be agreed on by the research team members and submitted to MUHREC for approval.
Research findings will be published in peer-reviewed journals and shared through presentations at conferences and seminars. The publication will also be disseminated to the participating community pharmacies and interested participants.
Discussion
To our best knowledge, this pragmatic cluster RCT will be the first study to determine the impact of a community pharmacy-based, digital health-supported pre-diabetes lifestyle intervention programme in Malaysia. While evidence suggests that community pharmacies can play a valuable role in preventing diabetes,52–55 data on the impact of community pharmacy-based diabetes prevention programmes remain scarce and inconclusive.
Pre-diabetes management requires a multifaceted approach targeting physical, psychological and social factors that shape behaviour. Although digital health-supported lifestyle interventions have been shown to improve the health of people with pre-diabetes,16 face-to-face interactions and support from healthcare professionals and peers remain important to support the effectiveness of these interventions.56 57 Community pharmacies are frequently lauded for the high level of convenience and accessibility that they offer to the public.55 The convenience and accessibility of community pharmacies allow for opportunistic screening of pre-diabetes among individuals, especially the regular patrons, and enable routine monitoring and follow-up among those detected with pre-diabetes. The PRIME programme brings together the benefits of using digital health technology, community pharmacy support and peer support to implement a pre-diabetes management programme in the real-world setting. This study follows a mixed-method approach by using both quantitative and qualitative methods, which will provide valuable information on the impact and acceptance of a community pharmacy-based pre-diabetes management programme in Malaysia. Results of this study will provide insights that will help to further improve the effectiveness of the PRIME programme, and ensure that delivery of the intervention is appropriate for a culturally-diverse community.
There are some potential limitations in this study. Participants who are less technologically savvy may be less willing to participate in this study. This study will not specifically identify participants with IGT, as administering OGTT is not feasible in a community pharmacy setting. Participants may also be non-adherent to the intervention during the follow-up period. To address this, the participants will be given reminders and ample opportunity to address any queries related to the mobile application and the intervention during their face-to-face visits at the pharmacy.
In summary, the rising prevalence of T2D necessitates the implementation of effective programmes that promote the early detection and management of pre-diabetes. The PRIME programme provides a solution that is convenient, readily available and easily accessible to the public.
Ethics statements
Patient consent for publication
Acknowledgments
The authors would like to thank Wong Hooi Fen and Lee Yean Ling from Caring Pharmacy for their valuable contributions in the development of the study protocol. The authors would also like to thank Bionime Malaysia for support in training and for facilitating access to resources essential to the study.
References
Supplementary materials
Supplementary Data
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
Footnotes
X @CarmenTeoh, @markcheongwl
Contributors KWT: conceptualisation, methodology, investigation, ethical approval, writing—original draft, writing—review and editing, visualisation and project administration, resources. SWHL: conceptualisation, methodology, writing—review and editing, resources, supervision. CMN: conceptualisation, writing—review and editing, supervision. CWC: conceptualisation, funding acquisition, writing—review and editing, supervision. YLN: conceptualisation, writing—review and editing, resources. JSB: methodology, writing—reviews and edits, supervision. WLC: methodology, writing—review and editing. All authors read and approved the final manuscript. The guarantor of the study is SWHL; accepts full responsibility for the finished work and/or the conduct of the study, has access to the data and controls the decision to publish.
Funding This work was supported by the Monash University Malaysia Network for Equity through Digital Health (NEED) Grant (Project code: I-M010-MTC-000007). Funding for this trial covers the purchase of equipment and consumables needed in the study, hiring of a research assistant and fieldwork travel expenses only. The design, collection, management, analysis, data interpretation, and reporting of this protocol are conducted independently from the funding body.
Competing interests None declared.
Patient and public involvement Patients and/or the public will be involved in the design, conduct, reporting or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.