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.

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.

Patient and family involvement in decision making for management of cancer patients at a centre in Singapore.

BACKGROUND: The practice of patient autonomy within the prevailing bioethical framework in the West appears increasingly at odds with the prominent influence of the family in medical decision making in the Asian culture. The actual extent of involvement of patient versus the family in the decision making process for cancer management in clinical practice is largely unknown in Asia. AIMS: (1) To describe patient and family involvement in healthcare decision making in actual practice, and to determine whether those practices are consistent with Singapore law; and (2) to act as a pilot for a larger prospective study examining the preferences of cancer patients on the decision making process, and the reasons for excluding patients from that process. METHODS: A retrospective review of patients who died in an oncology ward in Singapore General Hospital from February to April 2011. Patient and family involvement in discussions on (1) disclosure of diagnosis, (2) initial treatment decisions and (3) initiation of a 'maximum ward management' order was evaluated by reviewing case notes completed by healthcare professionals. RESULTS: Data were collected for 55 patients. Involvement of patients and families at first disclosure of diagnosis was noted in 61% and 64% of cases, respectively. In 12% of cases, the family requested withholding of the diagnosis from the patient. 86% of patients were involved in the initial treatment decisions, and their family was involved in 65% of cases. Only 9% of the 32 alert patients were consulted in end of life decisions. Factors associated with lower patient involvement were advanced age and inability to speak English. CONCLUSIONS: While most cancer patients are involved in the healthcare decision making process during the early phase, familial involvement gains prominence as the disease progresses.