Factors associated with usability of the EMPOWER-SUSTAIN Global Cardiovascular Risks Self-Management Booklet© among individuals with metabolic syndrome in primary care: a cross-sectional study.

BACKGROUND: Self-management support has been recognized as one of the most essential elements of the Chronic Care Model (CCM). Inspired by the CCM, the EMPOWER-SUSTAIN Global Cardiovascular Risks Self-Management Booklet© was developed to aid and sustain self-management among patients with metabolic syndrome (MetS) in primary care to prevent cardiovascular complications. However, the usability of this booklet among these patients is not known. Therefore, this study aimed to evaluate the usability of this self-management booklet and identify the factors associated with its usability among patients with MetS in primary care. METHODS: This cross-sectional study was conducted among patients with MetS attending a university primary care clinic in Selangor, Malaysia. The usability score was measured using a previously translated and validated EMPOWER-SUSTAIN Usability Questionnaire (E-SUQ) with a score of > 68 indicating good usability. Multiple logistic regressions determined the factors associated with its usability. RESULTS: A total of 391 patients participated in this study. More than half (61.4%) had a good usability score of > 68, with a mean (± SD) usability score of 72.8 (± 16.1). Participants with high education levels [secondary education (AOR 2.46, 95% CI 1.04, 5.83) and tertiary education (AOR 2.49, 95% CI 1.04, 5.96)], those who used the booklet at home weekly (AOR 2.94, 95% CI 1.63, 5.33) or daily (AOR 2.73, 95% CI 1.09, 6.85), and those who had social support to use the booklet (AOR 1.64, 95% CI 1.02, 2.64) were significantly associated with good usability of the booklet. CONCLUSIONS: The usability of the EMPOWER-SUSTAIN Global Cardiovascular Risks Self-Management Booklet© was good among patients with MetS in this primary care clinic, which supports its widespread use as a patient empowerment tool. The findings of this study also suggest that it is vital to encourage daily or weekly use of this booklet at home, with the support of family members. The focus should also be given to those with lower education to improve the usability of this booklet for this group of patients.

Design, development, utility and usability testing of the EMPOWER-SUSTAIN Self-Management Mobile App© among primary care physicians and patients with metabolic syndrome.

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.

The EMPOWER-SUSTAIN e-Health Intervention to improve patient activation and self-management behaviours among individuals with Metabolic Syndrome in primary care: study protocol for a pilot randomised controlled trial.

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.

Effectiveness of the EMPOWER-PAR Intervention in Improving Clinical Outcomes of Type 2 Diabetes Mellitus in Primary Care: A Pragmatic Cluster Randomised Controlled Trial.

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.