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BACKGROUND: The prevalence of type 2 diabetes mellitus (T2DM) is increasing worldwide. Digital interventions that incorporate the use of mobile phones and wearables have been getting popular. A combination of a digital intervention with support from professional management can enhance users' self-efficacy better than a digital intervention alone and provide better accessibility to a lifestyle intervention. However, there are limited studies exploring the feasibility and efficacy of applying a digital intervention in Muslim-majority countries, and none have been conducted in Brunei Darussalam. OBJECTIVE: The study aims to determine the effectiveness and feasibility of a proposed 16-week digital intervention program for T2DM self-management and to guide the rollout of a mobile app as part of a population health solution for adults with T2DM in Brunei. The primary outcome of this study is to measure the proportion of participants with a hemoglobin A1c (HbA1c) reduction of at least 0.6% from baseline, and the secondary outcomes include a change in HbA1c, BMI, lipid profile, and EQ-5D-5L score. METHODS: This single-arm nonrandomized pilot study will recruit participants using web-based (with the national health care app [BruHealth] and official social media platforms being used for outreach) and offline (in-person recruitment at health centers) approaches. A target of 180 individuals with T2DM aged between 20 and 70 years that meet the inclusion criteria will be enrolled in a 16-week digital intervention program. Baseline and postintervention markers will be evaluated. RESULTS: The study received approval from the Medical and Health Research & Ethics Committee of the Brunei Darussalam Ministry of Health (MHREC/MOH/2022/4(1)). The recruitment process is ongoing, and we anticipate that the study will conclude by April 2023. This will be followed by data analysis and the reporting of outcomes with the intention to publish. The results of this study will be disseminated through scientific publications and conferences. This study will serve as a guide to launch T2DM digital therapeutic programs and extend to other noncommunicable diseases (NCDs) if proven as an effective and feasible approach in Brunei. CONCLUSIONS: The Development and Exploration of the Effectiveness and Feasibility of a Digital Intervention for Type 2 Diabetes Mellitus (DEsireD) study will be the first study to investigate the clinical effectiveness and feasibility of the proposed 16-week T2DM digital intervention program tailored for Brunei, a Muslim-majority country. The findings of this study can potentially scale up the proposed model of care to other NCDs as a national approach for health management solutions. TRIAL REGISTRATION: ClinicalTrials.gov NCT05364476; https://clinicaltrials.gov/ct2/show/NCT05364476. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43208.
ABSTRACT
INTRODUCTION: Frailty begins in middle life and manifests as a decline in functional fitness. We described a model for community frailty screening and factors associated with prefrailty and frailty and fitness measures to distinguish prefrail/frail from robust older adults. We also compared the Fatigue, Resistance, Ambulation, Illnesses and Loss of weight (FRAIL) scale against Fried frailty phenotype and Frailty Index (FI). MATERIALS AND METHODS: Community-dwelling adults ≥55 years old were designated robust, prefrail or frail using FRAIL. The multidomain geriatric screen included social profiling and cognitive, psychological and nutritional assessments. Physical fitness assessments included flexibility, grip strength, upper limb dexterity, lower body strength and power, tandem and dynamic balance and cardiorespiratory endurance. RESULTS: In 135 subjects, 99 (73.3%) were robust, 34 (25.2%) were prefrail and 2 (1.5%) were frail. After adjusting for age and sex, depression (odds ratio [OR], 2.90; 95% confidence interval [CI], 1.05-7.90; P = 0.040) and malnutrition (OR, 6.07; 95% CI, 2.52-14.64; P <0.001) were independently associated with prefrailty/frailty. Prefrail/frail participants had significantly poorer performance in upper limb dexterity (P = 0.030), lower limb power (P = 0.003), tandem and dynamic balance (P = 0.031) and endurance (P = 0.006). Except for balance and flexibility, all fitness measures differentiated prefrail/frail from robust women. In men, only lower body strength was significantly associated with frailty. Area under receiver operating characteristic curves for FRAIL against FI and Fried were 0.808 (0.688-0.927, P <0.001) and 0.645 (0.546-0.744, P = 0.005), respectively. CONCLUSION: Mood and nutrition are targets in frailty prevention. Physical fitness declines early in frailty and manifests differentially in both genders.
