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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., Trial Registration: ClinicalTrials.gov, NCT04120779. Registered on 9 October 2019, protocol version 1.

Background and Aims: This study aimed to determine knowledge, awareness and practice (KAP) regarding familial hypercholesterolaemia (FH) among Malaysian primary care physicians (PCP), and to compare KAP between PCP with postgraduate qualification (PCP-PG-Qual) and PCP without PG qualification (PCP-noPG-Qual)., Methods: This was a cross-sectional study involving PCP with ≥1-year working experience in Malaysian primary care settings. An adapted and validated 25-item FH-KAP questionnaire was disseminated during primary care courses. Total score for each domain was calculated by summing-up the correct responses, converted into percentage scores. Normality distribution was examined and comparisons of mean/median percentage scores were made between the two groups of PCP., Results: A total of 372 PCP completed the questionnaire. Regarding knowledge, 77.7% correctly defined FH. However, only 8.3% correctly identified coronary artery disease risk in untreated FH. The mean percentage knowledge score was significantly higher in PCP-PG-Qual compared to PCP-noPG-Qual (48.9, SD ± 13.92 vs. 35.2, SD ± 14.13), t(370) = 8.66, p < 0.001. Regarding awareness, 39% were aware of the NICE FH guideline and only 27.2% were aware of FH diagnostic criteria. The median percentage awareness score was significantly higher in PCP-PG-Qual compared to PCP-noPG-Qual (15.4, IqR ± 23.08 vs. 7.7, IqR ± 11.54), p = 0.013. Regarding practice, only 19.1% stratified FH patients as high risk irrespective of other risk factors. The mean percentage practice score was significantly higher in PCP-PG-Qual compared to PCP-noPG-Qual (52.4, SD ± 12.92 vs. 42.7, SD ± 16.63), t(370) = 9.65, p < 0.001., Conclusions: Substantial gaps in FH-KAP among Malaysian PCP were identified, with PCP-PG-Qual having better knowledge, awareness and practice than PCP-noPG-Qual, emphasising the importance of professional training and certification., (Crown Copyright © 2018. Published by Elsevier B.V. All rights reserved.)

Background: Majority of patients with chronic illnesses such as diabetes, receive care at primary care setting. Efforts have been made to restructure diabetes care in the Malaysian primary care setting in accordance with the Chronic Care Model (CCM). The Patient Assessment on Chronic Illness Care (PACIC) is a validated self-report tool to measure the extent to which patients with chronic illness receive care that aligns with the CCM. To date, no validated tool is available to evaluate healthcare delivery based on the CCM in the Malay language. Thus, the study aimed to translate the PACIC into the Malay language and validate the questionnaire among patients with diabetes in the Malaysian public primary care setting., Methods: The English version of the PACIC questionnaire is a 20-item scale measuring five key components, which are patient activation, decision support, goal setting, problem solving and follow-up care. The PACIC underwent forward - backward translation and cross cultural adaptation process to produce the PACIC-Malay version (PACIC-M). Reliability was tested using internal consistencies and test-retest reliability analyses, while construct validity was tested using the exploratory factor analysis (EFA)., Results: The content of PACIC-M and the original version were conceptually equivalent. Overall, the internal consistency by Cronbach's α was .94 and the intra-class correlation coefficient was .93. One item was deleted (item 1) when the factor loading was < 0.4. The factor analyses using promax identified three components ('Goal Setting/Tailoring and Problem solving/Contextual', 'follow-up/coordination' and 'patient activation and delivery system design/ decision support'); explaining 61.2% of the variation. The Kaiser-Meyer-Olkin (KMO) was 0.93 and Bartlett's test of sphericity was p = .000. Therefore, the final version of the PACIC-M consisted of 19 items, framed within three components., Conclusion: The findings demonstrated that the PACIC-M measured different dimensions from the English version of PACIC. It is however; highly reliable and valid to be used in assessing three CCM model subscales. Further confirmatory factor analysis of PACIC-M should be conducted to confirm this new model.

Introduction: Non-communicable diseases (NCD) is a global health threat. the Chronic Care Model (CCM) was proven effective in improving NCD management and outcomes in developed countries. Evidence from developing countries including Malaysia is limited and feasibility of CCM implementation has not been assessed. this study intends to assess the feasibility of public primary health care clinics (PHC) in providing care according to the CCM., Methodology: A cross-sectional survey was conducted to assess the public PHC ability to implement the components of CCM. All public PHC with Family Medicine Specialist in Selangor and Kuala Lumpur were invited to participate. A site feasibility questionnaire was distributed to collect site investigator and clinic information as well as delivery of care for diabetes and hypertension., Results: there were a total of 34 public PHC invited to participate with a response rate of 100%. there were 20 urban and 14 suburban clinics. the average number of patients seen per day ranged between 250-1000 patients. the clinic has a good mix of multidisciplinary team members. All clinics had a diabetic registry and 73.5% had a hypertensive registry. 23.5% had a dedicated diabetes and 26.5% had a dedicated hypertension clinic with most clinic implementing integrated care of acute and NCD cases., Discussion: the implementation of the essential components of CCM is feasible in public PHCs, despite various constraints. Although variations in delivery of care exists, majority of the clinics have adequate staff that were willing to be trained and are committed to improving patient care.

Background: The 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., Methods: This 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., Results: A 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., Conclusions: This 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 Registration: Registered with: ClinicalTrials.gov.: NCT01545401 . Date of registration: 1st March 2012.

Background: Chronic 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/design: A 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., Discussion: Results 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 Registration: ClinicalTrials.gov NCT01545401.