BackgroundThe chronic care model was proven effective in improving clinical outcomes of diabetes in developed countries. However, evidence in developing countries is scarce. The objective of this study was to evaluate the effectiveness of EMPOWER-PAR intervention (based on the chronic care model) in improving clinical outcomes for type 2 diabetes mellitus using readily available resources in the Malaysian public primary care setting.MethodsThis was a pragmatic, cluster-randomised, parallel, matched pair, controlled trial using participatory action research approach, conducted in 10 public primary care clinics in Malaysia. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another five clinics continued with usual care. Patients who fulfilled the criteria were recruited over a 2-week period by each clinic. The obligatory intervention components were designed based on four elements of the chronic care model i.e. healthcare organisation, delivery system design, self-management support and decision support. The primary outcome was the change in the proportion of patients achieving HbA1c < 6.5%. Secondary outcomes were the change in proportion of patients achieving targets for blood pressure, lipid profile, body mass index and waist circumference. Intention to treat analysis was performed for all outcome measures. A generalised estimating equation method was used to account for baseline differences and clustering effect.ResultsA total of 888 type 2 diabetes mellitus patients were recruited at baseline (intervention: 471 vs. control: 417). At 1-year, 96.6 and 97.8% of patients in the intervention and control groups completed the study, respectively. The baseline demographic and clinical characteristics of both groups were comparable. The change in the proportion of patients achieving HbA1c target was significantly higher in the intervention compared to the control group (intervention: 3.0% vs. control: −4.1%, P < 0.002). Patients who received the EMPOWER-PAR intervention were twice more likely to achieve HbA1c target compared to those in the control group (adjusted OR 2.16, 95% CI 1.34–3.50, P < 0.002). However, there was no significant improvement found in the secondary outcomes.ConclusionsThis study demonstrates that the EMPOWER-PAR intervention was effective in improving the primary outcome for type 2 diabetes in the Malaysian public primary care setting.Trial registrationRegistered with: ClinicalTrials.gov.: NCT01545401. Date of registration: 1st March 2012. Electronic supplementary materialThe online version of this article (doi:10.1186/s12875-016-0557-1) contains supplementary material, which is available to authorized users.

BackgroundChronic disease management presents enormous challenges to the primary care workforce because of the rising epidemic of cardiovascular risk factors. The chronic care model was proven effective in improving chronic disease outcomes in developed countries, but there is little evidence of its effectiveness in developing countries. The aim of this study was to evaluate the effectiveness of the EMPOWER-PAR intervention (multifaceted chronic disease management strategies based on the chronic care model) in improving outcomes for type 2 diabetes mellitus and hypertension using readily available resources in the Malaysian public primary care setting. This paper presents the study protocol.Methods/DesignA pragmatic cluster randomised controlled trial using participatory action research is underway in 10 public primary care clinics in Selangor and Kuala Lumpur, Malaysia. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another five clinics continued with usual care. Each clinic consecutively recruits type 2 diabetes mellitus and hypertension patients fulfilling the inclusion and exclusion criteria over a 2-week period. The EMPOWER-PAR intervention consists of creating/strengthening a multidisciplinary chronic disease management team, training the team to use the Global Cardiovascular Risks Self-Management Booklet to support patient care and reinforcing the use of relevant clinical practice guidelines for management and prescribing. For type 2 diabetes mellitus, the primary outcome is the change in the proportion of patients achieving HbA1c < 6.5%. For hypertension without type 2 diabetes mellitus, the primary outcome is the change in the proportion of patients achieving blood pressure < 140/90 mmHg. Secondary outcomes include the proportion of patients achieving targets for serum lipid profile, body mass index and waist circumference. Other outcome measures include medication adherence levels, process of care and prescribing patterns. Patients’ assessment of their chronic disease care and providers’ perceptions, attitudes and perceived barriers in care delivery and cost-effectiveness of the intervention are also evaluated.DiscussionResults from this study will provide objective evidence of the effectiveness and cost-effectiveness of a multifaceted intervention based on the chronic care model in resource-constrained public primary care settings. The evidence should instigate crucial primary care system change in Malaysia.Trial RegistrationClinicalTrials.gov NCT01545401

Background: Epidemiological studies conducted in various parts of the world have clearly demonstrated that metabolic syndrome (MetS) is an increasing global health problem, not only in Western societies but also in Asian populations. Web-based and mobile phone-based self-management applications have been proven to be effective in improving self-management behaviour of patients with MetS components (i.e., diabetes or hypertension). However, evidence is lacking in terms of their effectiveness specifically for patients with MetS. The aim of this pilot study is to evaluate the feasibility and potential effectiveness of the EMPOWER-SUSTAIN Self-Management e-Health Intervention in improving activation and self-management behaviours among patients with MetS. This paper presents the study protocol.Methods: A pilot randomised controlled trial will be conducted in a university primary care clinic. A total of 232 patients aged 18-60 years with MetS will be recruited; 116 will be randomised to receive the EMPOWER-SUSTAIN intervention for 6 months, and another 116 patients will continue with usual care. The EMPOWER-SUSTAIN intervention is a multifaceted chronic disease management strategy based on the Chronic Care Model and persuasive technology theory. It consists of training primary care physicians, nurses and patients to use the EMPOWER-SUSTAIN web-based self-management mobile app, strengthening the patient-physician relationship and reinforcing the use of relevant clinical practice guidelines to guide management and prescribing. The primary outcome is the mean change in patient activation score using the Patient Activation Measure short form Malay version (PAM-13-M) questionnaire. The secondary outcomes include the changes in waist circumference, body mass index, blood pressure, patient physical activity level, eating behaviour, perception of chronic illness care, satisfaction with patient-physician interaction, and perceived absolute 10-year cardiovascular disease risk. Feasibility of implementing the intervention will be evaluated. This includes acceptability of the intervention, estimating the likely rate of participant recruitment and retention, appropriateness of the outcome measures, calculation of sample size, and the intervention's potential effectiveness. Conclusion: To our knowledge, this is the first study in Malaysia that aims to determine the feasibility of a multifaceted e-health intervention, as well as to indicate more useful aspects of this intervention for further exploration in a larger trial.

Background: Epidemiological studies from various parts of the world have clearly demonstrated that Metabolic Syndrome (MetS) is an increasing global health problem, not only in the western societies but also in the Asian populations. Web-based and mobile phone-based self-management applications have been proven to be effective in improving self-management behaviour in patients with MetS components i.e. diabetes or hypertension. However, evidence is lacking in terms of its effectiveness specifically for patients with MetS. The aim of this pilot study is to evaluate the feasibility and potential effectiveness of the EMPOWER-SUSTAIN © Self-Management e-Health Intervention in improving patient activation and self-management behaviours among patients with MetS. This paper presents the study protocol. Methods: A pilot randomised controlled trial will be conducted in a university primary care clinic. A total of 232 patients aged 18-60 years old with MetS will be recruited; 116 will be randomised to receive the EMPOWER-SUSTAIN © intervention for 6 months and another 116 patients will continue with usual care. The EMPOWER-SUSTAIN © intervention is a multifaceted chronic disease management strategy based on the Chronic Care Model and persuasive technology theory. It consists of training primary care physicians, nurse and patients to use the EMPOWER-SUSTAIN web-based self-management mobile app © , strengthening patient-physician relationship and reinforcing the use of relevant clinical practice guidelines to guide management and prescribing. The primary outcome is the mean change in patient activation score using the Patient Activation Measure ® short form Malay version (PAM ® -13-M) questionnaire. The secondary outcomes include the change in waist circumference, body mass index, blood pressure, patients’ physical activity level, eating behavior, patients’ perception on chronic illness care, satisfaction in patient-physician interaction and perceived absolute 10-year cardiovascular disease risk. Feasibility of implementing the intervention will be evaluated. These include acceptability of the intervention, estimating the likely rate of participant recruitment and retention, appropriateness of the outcome measures, calculation of sample size, and its potential effectiveness. Conclusion: To our knowledge, this is the first study in Malaysia that aims to determine the feasibility of a multifaceted e-health intervention, as well as to indicate more useful aspects of this intervention for further exploration in a larger trial.

AIM: The objective of this study was to evaluate the effectiveness of the EMPOWER- participatory action research (PAR) intervention, a multifaceted strategy based on the chronic care model (CCM) on primary care providers (PCP)’ adherence to type 2 diabetes mellitus (T2DM) clinical practice guideline (CPG) in the Malaysian primary care setting. METHODS: This was a pragmatic cluster randomized controlled trial –PAR conducted in ten public primary care clinics in Malaysia. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another five clinics continued with usual care. The outcome measure was the absolute change in the proportion of PCP’s adherence to T2DM CPG captured using the “Indicators of Care Pro forma,” based on the recommendation by the Malaysian CPG on the Management of T2DM. Data were collected from the patients’ medical records, at baseline and at 1-year follow-up; and were analyzed using mixed method model. RESULTS: A total of 888 patients were recruited at baseline; 471 were in the intervention and 417 were in the control group. There was no significant demographic difference between the two groups at baseline except for ethnicity. At 1-year, 455 (96.6%) and 406 (97.3%) patients in the intervention and control groups completed the study, respectively. There were significant improvements in the absolute change in the proportion of PCPs’ adherence to T2DM CPG in the intervention group compared to the control group at 1-year follow-up in several indicators of care. These included the recording of BMI (0.6% vs. −1.8%, p<0.001); performing foot examination (2.4% vs. 0.6%, p<0.001); performing funduscopy/fundus photography (1.5% vs. 0.3%, p<0.001); monitoring renal profile (0.9% vs. −0.6%, p=0.001); measuring urine protein (1.2% vs. 0.6%, p<0.001), and giving lifestyle modification and self-management advice (1.2% vs. −0.3%, p<0.001) in the intervention versus control groups, respectively. CONCLUSION: The EMPOWER-PAR intervention has been proven to be effective in improving the PCPs’ adherence to T2DM CPG in several indicators of care. Findings from this study provided objective evidence of the effectiveness of multifaceted intervention based on the CCM in the Malaysian public primary care setting. TRIAL REGISTRATION: Registered with: ClinicalTrials.gov: NCT01545401. Date of registration: 1st March 2012.

Objective This study aimed to design, develop, assess and refine the EMPOWER-SUSTAIN Self-Management Mobile App© among primary care physicians (PCP) and patients with metabolic syndrome (MetS) in primary care. Methodology Using the software-development-life-cycle (SDLC) iterative model, storyboard and wireframe were drafted; and a mock prototype was designed to illustrate the content and function graphically. Subsequently, a working prototype was developed. Qualitative studies using the ‘think-aloud’ and cognitive-task-analysis methods were conducted for the utility and usability testing. Topic guide was based on the 10-Nielsen's-Heuristic-Principles. Utility testing was conducted among PCP in which they ‘thought-aloud’ while performing tasks using the mobile app. Usability testing was conducted among MetS patients after they were given the app for 3 weeks. They ‘thought-aloud’ while performing tasks using the app. Interviews were audio- and video-recorded, and transcribed verbatim. Thematic content analysis was performed. Result Seven PCP and nine patients participated in the utility and usability testing, respectively. Six themes (efficiency of use, user control and freedom, appearance and aesthetic features, clinical content, error prevention, and help and documentation) emerged. PCP found the mobile app attractive and relevant sections were easy to find. They suggested adding ‘zoom/swipe’ functions and some parts needed bigger fonts. Patients commented that the app was user-friendly, has nice interface, and straightforward language. It helped them understand their health better. Based on these findings, the mobile app was refined. Conclusion This app was produced using a robust SDLC method to increase users’ satisfaction and sustainability of its use. It could potentially improve self-management behaviour among MetS patients in primary care.

Introduction: There has been an exponential growth in mobile health (mHealth) technology for self-management of chronic conditions including metabolic syndrome (MetS). This narrative review aims to summarise the evidence on the effect of mHealth interventions on clinical outcomes and/or self-management behaviours among individuals with MetS or its components. Methods: Literature search for original research articles on mHealth for self-management of MetS or any of its components (type 2 diabetes mellitus, hypertension, dyslipidaemia, and obesity) from 2010-2021 was conducted using Web of Science, Scopus, PubMed, Cochrane Central Register of Controlled Trials, Google Scholar, SAGE and ScienceDirect. Keywords such as mHealth, effectiveness, self-management, MetS, hypertension, type 2 diabetes mellitus, dyslipidaemia and obesity were used. Articles in languages other than English, without access to full-text, outcomes unrelated to the effectiveness, and involved individuals aged <18 or >80 years old were excluded. All study designs were included except for study protocols. Results: A total of 184 potential papers were retrieved. Of these, 137 were excluded as they did not meet the inclusion/exclusion criteria. Consequently, 47 papers were included. Of these, 38 studies demonstrated effect of mHealth interventions in improving clinical outcomes (blood pressure, glycated haemoglobin, lipid profile, weight) and/or improvement in self-management behaviours (home blood pressure or blood sugar monitoring, exercise, diet or medication adherence) among individuals with MetS or its components. Only 12 studies were conducted in primary care. Apart from mHealth technologies, multifaceted elements such as doctor-patient interaction and wearable devices were also shown to be effective. Conclusion: This narrative review suggests that mHealth interventions may have positive effect on clinical outcomes and/or self-management behaviours among individuals with MetS and its components. This evidence should support development and evaluation of mHealth interventions to suit the needs of the Malaysian population, especially in primary care.

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