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BACKGROUND: Despite availability of clinical practice guidelines for hypertension management, blood pressure (BP) control remains sub-optimal (<30%) even in high-income countries. This study aims to assess the effectiveness of a potentially scalable multicomponent intervention integrated into primary care system compared to usual care on BP control. METHODS AND FINDINGS: A cluster-randomized controlled trial was conducted in 8 government clinics in Singapore. The trial enrolled 916 patients aged ≥40 years with uncontrolled hypertension (systolic BP (SBP) ≥140 mmHg or diastolic BP (DBP) ≥90 mmHg). Multicomponent intervention consisted of physician training in risk-based treatment of hypertension, subsidized losartan-HCTZ single-pill combination (SPC) medications, nurse training in motivational conversations (MCs), and telephone follow-ups. Usual care (controls) comprised of routine care in the clinics, no MC or telephone follow-ups, and no subsidy on SPCs. The primary outcome was mean SBP at 24 months' post-baseline. Four clinics (447 patients) were randomized to intervention and 4 (469) to usual care. Patient enrolment commenced in January 2017, and follow-up was during December 2018 to September 2020. Analysis used intention-to-treat principles. The primary outcome was SBP at 24 months. BP at baseline, 12 and 24 months was modeled at the patient level in a likelihood-based, linear mixed model repeated measures analysis with treatment group, follow-up, treatment group × follow-up interaction as fixed effects, and random cluster (clinic) effects. A total of 766 (83.6%) patients completed 2-year follow-up. A total of 63 (14.1%) and 87 (18.6%) patients in intervention and in usual care, respectively, were lost to follow-up. At 24 months, the adjusted mean SBP was significantly lower in the intervention group compared to usual care (-3.3 mmHg; 95% CI: -6.34, -0.32; p = 0.03). The intervention led to higher BP control (odds ratio 1.51; 95% CI: 1.10, 2.09; p = 0.01), lower odds of high (>20%) 10-year cardiovascular risk score (OR 0.67; 95% CI: 0.47, 0.97; p = 0.03), and lower mean log albuminuria (-0.22; 95% CI: -0.41, -0.02; p = 0.03). Mean DBP, mortality rates, and serious adverse events including hospitalizations were not different between groups. The main limitation was no masking in the trial. CONCLUSIONS: A multicomponent intervention consisting of physicians trained in risk-based treatment, subsidized SPC medications, nurse-delivered motivational conversation, and telephone follow-ups improved BP control and lowered cardiovascular risk. Wide-scale implementation of a multicomponent intervention such as the one in our trial is likely to reduce hypertension-related morbidity and mortality globally. TRIAL REGISTRATION: Trial Registration: Clinicaltrials.gov NCT02972619.
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Hipertensão , Anti-Hipertensivos/efeitos adversos , Pressão Sanguínea , Humanos , Hipertensão/tratamento farmacológico , Funções Verossimilhança , Atenção Primária à Saúde , SingapuraRESUMO
BACKGROUND: Chronic kidney disease (CKD) poses a global health challenge with high morbidity and mortality rates. Early detection and prompt intervention are critical in preventing progression to end-stage kidney disease (ESKD) and cardiovascular complications. Effective CKD management requires comprehensive care packages that integrate both pharmacological and non-pharmacological interventions within collaborative, team-based models, aiming to enhance patient outcomes and overall quality of life. The goal of the Strategies for Kidney Outcomes Prevention and Evaluation (SKOPE) study is to establish effective multicomponent intervention (MCI) strategies for evaluating and preventing kidney outcomes in patients with moderate to advanced CKD within primary care settings in Singapore. METHODS: This study is a 3-year randomized controlled trial among 896 participants aged between 40 and 80 years with moderate or advanced CKD in five government-subsidized polyclinics in Singapore. The components of the MCI are (1) nurses/service coordinators trained as health coaches for motivational conversation and CKD-specific lifestyle counseling on diet and exercise, using a hybrid follow-up approach of in-person, telephone, and secure video meetings; (2) training physicians in algorithm-based standardized management of CKD; (3) subsidy on SGLT2i medications for CKD; and (4) regular CKD case review meetings. The primary outcome is the estimated glomerular filtration rate (eGFR) total slope from randomization to final follow-up at 36 months. DISCUSSION: If shown to be effective, cost-effective, and acceptable, SKOPE should be considered for scaling country-wide and in similar regional healthcare systems. TRIAL REGISTRATION: ClinicalTrials.gov NCT05295368. Registered on March 25, 2022.
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Ensaios Clínicos Controlados Aleatórios como Assunto , Insuficiência Renal Crônica , Humanos , Insuficiência Renal Crônica/terapia , Insuficiência Renal Crônica/diagnóstico , Singapura , Pessoa de Meia-Idade , Idoso , Adulto , Masculino , Feminino , Idoso de 80 Anos ou mais , Qualidade de Vida , Resultado do Tratamento , Progressão da Doença , Estudos Multicêntricos como Assunto , Fatores de Tempo , Atenção Primária à Saúde , Rim/fisiopatologia , Taxa de Filtração GlomerularRESUMO
Importance: Lifestyle interventions are effective in diabetes management, with smartphone apps that manage health data and dietary and exercise schedules gaining popularity. However, limited evidence from randomized clinical trials exists regarding the effectiveness of smartphone-based interventions among Asian adults with type 2 diabetes. Objective: To compare the effects of a culturally contextualized smartphone-based intervention with usual care on weight and metabolic outcomes. Design, Setting, and Participants: This randomized clinical trial conducted at multiple primary care centers in Singapore included 305 adults with type 2 diabetes and body mass index (BMI) of 23 or greater who had literacy in English and smartphone access. Participants were recruited between October 3, 2017, and September 9, 2019, and were randomly assigned (1:1; stratified by gender, age, and BMI) to intervention (99 participants) or control (105 participants) groups. Participants' data were analyzed using intention-to-treat analysis. Interventions: Both control and intervention participants received diet and physical activity advice from a dietitian at a baseline face-to-face visit. Intervention participants additionally used a smartphone app to track weight, diet, physical activity, and blood glucose and then communicated with dietitians for 6 months. Main Outcomes and Measures: Primary outcome was change in body weight, while secondary outcomes were changes in hemoglobin A1c (HbA1c), fasting blood glucose, blood pressure, lipids, and diet. Post hoc analyses included glycemic changes in the subgroup with HbA1c levels of 8% or greater and diabetes medication changes. Results: Among the 204 randomized participants (mean [SD] age, 51.2 [9.7] years; 132 [64.7%] men), baseline mean (SD) BMI was 30.6 (4.3). Compared with the control group, intervention participants achieved significantly greater reductions in weight (mean [SD] change, -3.6 [4.7] kg vs -1.2 [3.6] kg) and HbA1c levels (mean [SD] change, -0.7% [1.2] vs -0.3% [1.0]), with a greater proportion having a reduction in diabetes medications (17 participants [23.3%] vs 4 participants [5.4%]) at 6 months. The intervention led to a greater HbA1c reduction among participants with HbA1c levels of 8% or higher (mean [SD] change, -1.8% [1.4] vs -1.0% [1.4]; P = .001). Intergroup differences favoring the intervention were also noted for fasting blood glucose, diastolic blood pressure, and dietary changes. Conclusions and Relevance: In this study, a smartphone-based lifestyle intervention was more effective in achieving weight and glycemic reductions among Asian adults with type 2 diabetes compared with usual care, supporting the use of apps in lifestyle intervention delivery. Trial Registration: anzctr.org.au Identifier: ACTRN12617001112358.
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Povo Asiático/educação , Terapia Comportamental/métodos , Diabetes Mellitus Tipo 2/terapia , Estilo de Vida Saudável , Aplicativos Móveis , Educação de Pacientes como Assunto/métodos , Smartphone , Redução de Peso , Adulto , Idoso , Povo Asiático/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Singapura , Adulto JovemRESUMO
INTRODUCTION: Landmark studies have established that lifestyle interventions focused on weight loss, diet modification and physical activity can prevent diabetes progression. However, the effectiveness of mobile health application among Asians with prediabetes remains largely unexamined. We aimed to assess whether a smartphone app-based lifestyle intervention program would lead to weight loss, normoglycemia and improved metabolic indices in a multiethnic Asian population with prediabetes. RESEARCH DESIGN AND METHODS: This multicentre prediabetes RCT is part of the Diabetes Lifestyle Intervention using Technology Empowerment (D'LITE) trial. Adults (n = 148) with prediabetes and BMI ≥ 23 kg/m2 were randomly allocated either to the intervention group (n = 72) empowered by self-monitoring features of the Nutritionist Buddy Diabetes app with in-app dietitian coaching for 6 months, or the control group (n = 76) receiving standard diet counseling at baseline. Primary outcome was defined as change in body weight at 6 months, while secondary outcomes included glycemic control and other metabolic indices analyzed using Generalized Linear Mixed Model analysis with intention-to-treat approach. RESULTS: Intervention group achieved a significantly greater weight loss of 4.2 vs. 1.3 kg [mean difference of -3.1 kg (95% CI -4.5 to -1.7), p < 0.001], and a 4.3-fold increased likelihood of achieving ≥ 5% weight loss, as compared to the control group at 6 months. The likelihood of achieving normoglycemia (defined as HbA1c < 5.7%) was 2.1 times higher in intervention group than in the control group (p < 0.018). Changes to blood pressure, total and LDL cholesterol were not statistically significant. CONCLUSION: An app-based lifestyle program led to clinically significant weight loss and improved glycemia, and can potentially augment current standard care in the prevention of diabetes among an Asian multiethnic population. CLINICAL TRIAL REGISTRATION: anzctr.org.au, identifier: ACTRN12617001112358.
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BACKGROUND: Hypertension is a serious public health problem in Singapore and is associated with significant morbidity and mortality from cardiovascular disease (CVD) with considerable implications for health-care resources. The goal of the trial is to compare a multicomponent intervention (MCI) to usual care to evaluate the effectiveness and cost-effectiveness of the MCI for lowering blood pressure (BP) among adults with uncontrolled hypertension in Singapore primary-care clinics. METHODS/DESIGN: The study is a cluster randomized trial in eight polyclinics in Singapore: four deliver a structured MCI and four deliver usual care. The components of the MCI are: (1) an algorithm-driven antihypertensive treatment for all hypertensive individuals using single-pill combination (SPC) and lipid-lowering medication for high-risk hypertensive individuals, (2) a motivational conversation for high-risk hypertensive individuals, (3) telephone-based follow-ups of all hypertensive individuals by polyclinic nurses, and (4) discounts on SPC antihypertensive medications. The trial will be conducted with 1000 individuals aged ≥ 40 years with uncontrolled hypertension (systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg, based on the mean of the last two of three measurements) in eight polyclinics in Singapore. The primary outcome is change in systolic BP from baseline to follow-up at 24 months post-randomization. The incremental cost of MCI per CVD disability adjusted life years (DALY) averted and quality adjusted life years (QALY) saved will be computed. DISCUSSION: The demonstration of an effective and cost-effective hypertension control program that is implementable in busy polyclinics would provide compelling evidence for upscaling the program across all primary-care centers in Singapore, and possibly other regional countries with a similar health-care structure. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02972619 . Registered on 23 November 2016.
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Hipertensão/tratamento farmacológico , Adulto , Análise Custo-Benefício , Aconselhamento , Humanos , Hipertensão/etiologia , Motivação , Avaliação de Resultados em Cuidados de Saúde , Fatores de Risco , Tamanho da AmostraRESUMO
INTRODUCTION: Plantar fasciitis is a commonly seen outpatient condition that has numerous treatment modalities of varying degrees of efficacy. This systematic review aimed to determine the effectiveness of acupuncture in reducing pain caused by plantar fasciitis. METHODS: Online literature searches were performed on the PubMed and Cochrane Library databases for studies on the use of acupuncture for pain caused by plantar fasciitis. Studies designed as randomised controlled trials and that compared acupuncture with standard treatments or had real versus sham acupuncture arms were selected. The Delphi list was used to assess the methodological quality of the studies retrieved. RESULTS: Three studies that compared acupuncture with standard treatment and one study on real versus sham acupuncture were found. These showed that acupuncture significantly reduced pain levels in patients with plantar fasciitis, as measured on the visual analogue scale and the Plantar Fasciitis Pain/Disability Scale. These benefits were noted between four and eight weeks of treatment, with no further significant reduction in pain beyond this duration. Side effects were found to be minimal. CONCLUSION: Although acupuncture may reduce plantar fasciitis pain in the short term, there is insufficient evidence for a definitive conclusion regarding its effectiveness in the longer term. Further research is required to strengthen the acceptance of acupuncture among healthcare providers.
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Terapia por Acupuntura , Fasciíte Plantar/terapia , Manejo da Dor , Medição da Dor , Adulto , Eletroacupuntura , Feminino , Humanos , Lasers , Masculino , Pessoa de Meia-Idade , Dor , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do TratamentoRESUMO
BACKGROUND: An AD8 cut-off score of ≥4 has been reported to successfully detect 90% of dementia cases in elderly patients aged 75 years and above. OBJECTIVE: We investigated the benefits of a pilot clinical service conducted in primary care that used the AD8 to identify patients with dementia in an at-risk population. METHOD: Patients ≥75 years of age were recruited from a primary health care center in Singapore. Trained nurses administered the AD8 to informants of eligible patients. Patients screened positive (AD8 score ≥4) were referred to specialist memory clinics by primary health care physicians for further evaluation. RESULTS: Of the 551 eligible patients in the primary health care center, 168 (30.5%) consented and the AD8 was administered to their informants. Among the recruited patients, 23 (13.7%) were screened positive and 7 (30.4%) of them accepted referrals to specialist memory clinics. The clinical diagnoses for these patients were as follows: no cognitive impairment (NCI) (n = 1), cognitive impairment no dementia (CIND) (n = 5), and dementia (n = 1). Most of the (98.8%) nurses found AD8 user-friendly and could track functional decline. Eighteen of the 23 (78.3%) primary health care physicians who referred patients to specialist memory clinics considered the AD8 useful for facilitating referrals. The remaining physicians (21.7%) preferred performance-based tests. CONCLUSION: The AD8 is easily administered by nurses and useful to a majority of primary health care physicians to generate referrals. However, physician preference for performance-based tests and a lower prevalence of dementia in the at-risk population may indicate the need to consider a "2-pronged assessment approach" that combines both performance-based and informant-based brief tests to reduce false positive rates and better detect dementia.