Empowering patients with comorbid diabetes and hypertension through a multi-component intervention of mobile app, health coaching and shared decision-making: Protocol for an effectiveness-implementation of randomised controlled trial.

INTRODUCTION: Diabetes and hypertension are prevalent and costly to the health system. We have developed a mobile app (EMPOWER app) which enables remote monitoring and education through personalised nudges. We aim to study the effectiveness of a multi-component intervention comprising the EMPOWER mobile app with health coaching and shared decision-making for diabetes and hypertension. METHODS: We will conduct a two-arm, open-label, pragmatic randomised controlled trial (RCT). Participants with comorbid diabetes and hypertension enrolled from public primary care clinics will be randomised to either intervention or control in a 1:1 ratio. The intervention group participants will have access to health coaching with shared decision-making interventions in addition to the EMPOWER app and their usual primary care. The control group participants will continue to receive usual primary care and will neither receive the EMPOWER app nor health coaching and shared decision-making interventions. Our primary outcome is change in HbA1c level over 9 months. Secondary outcomes include change in systolic blood pressure, quality of life, patient activation, medication adherence, physical activity level, diet, and healthcare cost (direct and indirect) over 9 months. DISCUSSION: Our trial will provide key insights into clinical- and cost-effectiveness of a multi-component intervention comprising EMPOWER mobile app, health coaching and shared decision-making in diabetes and hypertension management. This trial will also offer evidence on cost-effective and sustainable methods for promoting behavioural changes among patients with comorbid diabetes and hypertension. TRIAL REGISTRATION: This study was registered on clintrials.gov on August 3, 2022, with the trial registration number: NCT05486390.

Integrated care teams in primary care improve clinical outcomes and care processes in patients with non-communicable diseases.

Introduction: Primary care physicians face the increasing burden of managing multimorbidities in an ageing population. Implementing an integrated care team (ICT) with defined roles and accountability to share consultation tasks is an emerging care model to address this issue. This study compared outcomes with ICT versus usual care for patients with multimorbidities in primary care. Methods: Data was retrospectively extracted from the electronic medical records (EMRs) of consecutive adult Asian patients empanelled to ICT and those in UC at a typical primary care clinic (polyclinic) in eastern Singapore in 2018. The study population had hypertension, and/or hyperlipidaemia and/or type 2 diabetes mellitus (T2DM). Clinical outcomes included the proportion of patients (ICT vs. UC) who attained their treatment goals after 12 months. Process outcomes included the proportion of patients who completed annual diabetic eye and foot screenings, where applicable. Results: Data from 3,302 EMRs (ICT = 1,723, UC = 1,579) from January 2016 to September 2017 was analysed. The ICT cohort was more likely to achieve treatment goals for systolic blood pressure (SBP) (adjusted odds ratio [AOR] = 1.52, 95% confidence interval [CI] = 1.38-1.68), low-density lipoprotein cholesterol (AOR = 1.72, 95% CI = 1.49-1.99), and glycated haemoglobin (AOR = 1.28, 95% CI = 1.09-1.51). The ICT group had higher uptake of diabetic retinal screening (89.1% vs. 83.0%, P < 0.001) and foot screening (85.2% vs. 77.9%, P < 0.001). Conclusion: The ICT model yielded better clinical and process outcomes than UC, with more patients attaining treatment goals.

EMPOWERing Patients With Diabetes Using Profiling and Targeted Feedbacks Delivered Through Smartphone App and Wearable (EMPOWER): Protocol for a Randomized Controlled Trial on Effectiveness and Implementation.

Introduction: Type 2 diabetes mellitus (T2DM) poses huge burden and cost on the healthcare system. Mobile health (mHealth) interventions that incorporate wearables may be able to improve diabetes self-management. The aim of this randomized controlled trial (RCT) is to investigate the clinical and cost-effectiveness of personalized educational and behavioral interventions delivered through an EMPOWER mobile application (app) among patients with T2DM. Methods: This is a parallel two-arm randomized controlled trial (RCT). Patients with T2DM recruited from primary care will be randomly allocated in a 1:1 ratio to either intervention or control group. The intervention group will receive personalized educational and behavioral interventions through the EMPOWER app in addition to their usual clinical care. The control group will receive the usual clinical care for their T2DM but will not have access to the EMPOWER app. Our primary outcome is patient activation score at 12 months. Secondary outcomes will include HbA1c, physical activity level and diet throughout 12 months; quality of life (QoL), medication adherence, direct healthcare cost and indirect healthcare cost at 6 and 12 months. Discussion: This RCT will provide valuable insights into the effectiveness and implementation of personalized educational and behavioral interventions delivered through mobile application in T2DM management. Findings from this study can help to achieve sustainable and cost-effective behavioral change in patients with T2DM, and this can be potentially scaled to other chronic diseases such as hypertension and dyslipidemia.

Impact of specialized oral nutritional supplement on clinical, nutritional, and functional outcomes: A randomized, placebo-controlled trial in community-dwelling older adults at risk of malnutrition.

BACKGROUND & AIMS: The world's over-65 population is expanding rapidly, and the risk of malnutrition is prevalent in this population. Meeting nutritional needs is a recognized strategy to reduce and address multiple debilitating adverse health outcomes associated with malnutrition. The objective of this randomized, controlled trial was to determine the effects of oral nutritional supplement (ONS) containing beta-hydroxy-beta-methylbutyrate (HMB), along with dietary counseling, on health outcomes in community-dwelling older adults at risk of malnutrition. METHODS: Strengthening Health In ELDerly through nutrition (SHIELD) studied adults aged ≥ 65 years in Singapore who were recruited between August 2017 and March 2019. Participants were community ambulant and classified as medium or high risk for malnutrition using Malnutrition Universal Screening Tool (MUST). Participants (n = 811) were randomly assigned to one of two study treatments for 180 days: (i) two servings/day of ONS containing HMB with dietary counseling (n = 405) or (ii) two servings/day of placebo supplement with dietary counseling (n = 406). The primary composite outcome was 'survival without hospital (re)admission and with at least 5% weight gain to day 180'. Dietary intakes, nutritional and functional outcomes were measured at baseline, 30, 90, and 180 days. RESULTS: A higher proportion in intervention group met the 180-day primary composite outcome compared to placebo (33.4% vs. 8.7%, P < 0.001), largely driven by body weight component (36.2% vs. 9.4%, P < 0.001). Survival and hospital (re)admission rate were not significantly different between the groups. Weight, BMI, and mid upper arm circumference were significantly greater in the intervention group compared to placebo during the study (all P < 0.001), and at days 30, 90, and 180 (all P < 0.05). The odds of having better nutritional status during the study were also significantly higher in the intervention group compared to placebo, as measured using MUST risk (OR = 2.68, P < 0.001) and vitamin D status (OR = 4.23, P < 0.001). Intervention group had significantly higher energy, protein, fat, and carbohydrate intakes than the placebo group (all P ≤ 0.017). Leg strength at day 90 was significantly greater for the intervention group than for the placebo group (LSM ± SE: 12.85 ± 0.22 vs. 12.17 ± 0.22; P = 0.030). Handgrip strength for females was significantly higher at day 180 for the intervention group compared to placebo (LSM ± SE: 14.18 ± 0.17 vs. 13.70 ± 0.17; P = 0.048). Within the low appendicular skeletal muscle mass index (ASMI) subgroup, the intervention group had significantly greater calf circumference at days 90 and 180 compared to placebo (both P ≤ 0.0289). CONCLUSIONS: For community-dwelling older adults at risk of malnutrition, daily consumption of specialized ONS containing HMB and vitamin D for six months, along with dietary counseling, significantly improved nutritional and functional outcomes compared to placebo supplement with dietary counseling. CLINICAL TRIAL REGISTRATION: www.ClinicalTrials.govNCT03245047.

Factors associated with muscle mass in community-dwelling older people in Singapore: Findings from the SHIELD study.

OBJECTIVES: Aging is associated with low muscle mass and has been linked to adverse health outcomes. The objectives of this cross-sectional study were: (1) to describe anthropometry, body composition, appendicular skeletal muscle mass index (ASMI; appendicular skeletal muscle mass/height2), and prevalence of low ASMI in older people with normal nutritional status (Malnutrition Universal Screening Tool score = 0); (2) to determine factors associated with ASMI, and odds ratios of having low ASMI. METHODS: SHIELD is a study of community-dwelling older people aged 65 years and above in Singapore. ASMI was determined using bioelectrical impedance analysis and low ASMI was defined as <7.0 kg/m2 for males and <5.7 kg/m2 for females (Asian Working Group for Sarcopenia, 2014). RESULTS: A total of 400 older people (183 males and 217 females) took part in this study. The overall prevalence of low ASMI was 20.6% (15.5% in males and 24.9% in females). Females had significantly lower ASMI than males (P < 0.0001), age was inversely associated with ASMI (P = 0.0024) while BMI and calf circumference were positively associated with ASMI (both P < 0.0001) in the total cohort. In addition, ASMI was positively associated with bone mass in both genders (both P < 0.0001). After adjusting for covariates, the odds ratios of having low ASMI with every 1 year and 10 years increase in age were 1.13 (95% CI: 1.06, 1.20) and 3.36 (95% CI: 1.82, 6.21) respectively. CONCLUSIONS: The high prevalence of low ASMI in community-dwelling older people with normal nutritional status highlights the need for early screening. There was a strong inverse association between age and ASMI while BMI, calf circumference and bone mass were positively associated with ASMI. These findings will give further weight to the importance and development of public health strategies in maintaining and improving muscle health in this population group.