A Mobile Lifestyle Management Program (GlycoLeap) for People With Type 2 Diabetes: Single-Arm Feasibility Study.

BACKGROUND: Singapore's current prevalence of diabetes exceeds 13.6%. Although lifestyle modification can be effective for reducing the risks for complications of type 2 diabetes mellitus (T2DM), traditional lifestyle interventions are often difficult to administer in the primary care setting due to limited resources. Mobile health apps can address these limitations by offering low-cost, adaptable, and accessible platforms for disseminating lifestyle management interventions. OBJECTIVE: Using the RE-AIM evaluation framework, this study assessed the potential effectiveness and feasibility of GlycoLeap, a mobile lifestyle management program for people with T2DM, as an add-on to standard care. METHODS: This single-arm feasibility study recruited 100 patients with T2DM and glycated hemoglobin (HbA1c) levels of ≥7.5% from a single community health care facility in Singapore. All participants were given access to a 6-month mobile lifestyle management program, GlycoLeap, comprising online lessons and the Glyco mobile phone app with a health coaching feature. The GlycoLeap program was evaluated using 4 relevant dimensions of the RE-AIM framework: (1) reach (percentage who consented to participate out of all patients approached), (2) effectiveness (percentage point change in HbA1c [primary outcome] and weight loss [secondary outcome]), (3) implementation (program engagement as assessed by various participatory metrics), and (4) maintenance (postintervention user satisfaction surveys to predict the sustainability of GlycoLeap). Participants were assessed at baseline and at follow-up (≥12 weeks after starting the intervention). RESULTS: A total of 785 patients were approached of whom 104 consented to participate, placing the reach at 13.2%. Four were excluded after eligibility screening, and 100 patients were recruited. Program engagement (implementation) started out high but decreased with time for all evaluated components. Self-reported survey data suggest that participants monitored their blood glucose on more days in the past week at follow-up compared to baseline (P<.001) and reported positive changes to their diet due to app engagement (P<.001) (implementation). Primary outcome data were available for 83 participants. Statistically significant improvements were observed for HbA1c (-1.3 percentage points, P<.001) with greater improvements for those who logged their weight more often (P=.007) (effectiveness). Participants also had a 2.3% reduction in baseline weight (P<.001) (effectiveness). User satisfaction was high with 74% (59/80) and 79% (63/80) of participants rating the app good or very good and claiming that they would probably or definitely recommend the app to others, respectively (maintenance). CONCLUSIONS: Although measures of program engagement decreased with time, clinically significant improvements in HbA1c were achieved with the potential for broader implementation. However, we cannot rule out that these improvements were due to factors unrelated to GlycoLeap. Therefore, we would recommend evaluating the effectiveness and cost effectiveness of GlycoLeap using a randomized controlled trial of at least 12 months. TRIAL REGISTRATION: ClinicalTrials.gov NCT03091517; https://clinicaltrials.gov/ct2/show/NCT03091517 (Archived by WebCite at http://www.webcitation.org/77rNqhwRn).

Management of hypertension and multiple risk factors to enhance cardiovascular health in Singapore: The SingHypertension cluster randomized trial.

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.

Management of hypertension and multiple risk factors to enhance cardiovascular health - a feasibility study in Singapore polyclinics.

BACKGROUND: High blood pressure (BP) is a leading contributor to cardiovascular mortality globally. There is scarcity of information on effective health systems interventions to lower BP and reduce cardiovascular risk in Southeast Asian countries. We conducted a pilot exploratory trial on 100 adults aged 40 years or older with uncontrolled hypertension to optimize the design for a structured multi-component intervention in primary care clinics for management of hypertension. METHODS: Two clinics were involved, each enrolling 50 participants, with one as the intervention clinic and the other as the control (usual care). The intervention comprised the following four components: 1) an algorithm-driven intervention using a fixed-dose combination (FDC) antihypertensive treatment and lipid lowering medication for high risk individuals, 2) subsidized FDC antihypertensive medication; 3) motivational conversation (MC) for high risk individuals; and 4) telephone follow-ups of all individuals. The process outcomes were intervention fidelity measures. The outcomes of change in parameters of interest were healthy lifestyle index (composite score of body mass index, physical activity, dietary habit, dietary quality and smoking), adherence to antihypertensive medications, and systolic and diastolic BP from baseline to follow-up at 3 months. RESULTS: Greater than 90 % fidelity was achieved for 3 of the 4 intervention components. Although not designed for conclusive results, the healthy lifestyle score increased by 0.16 (±0.68) with the intervention and decreased by 0.18 (±0.75) with usual care (p = 0.02). Adherence to anti-hypertensive medications at follow-up was 95.3 % in the intervention group compared to 83.8 % for usual care (p = 0.01). Systolic and diastolic BP decreased in both intervention and control groups, although statistical significance between groups was not achieved. Hypertensive individuals rated all intervention components 'highly favorable' on a Likert scale. CONCLUSIONS: Our findings indicate that the proposed, structured multi-component approach for management of hypertension is feasible for implementation in primary care clinics in Singapore, with some changes to the protocol. The observed improvement in the healthy lifestyle index and adherence to anti-hypertensive medications is promising. A large scale, adequately powered trial would be informative to assess intervention effectiveness on BP and cardiovascular risk reduction. TRIAL REGISTRATION: This trial has been registered at ClinicalTrials.gov. ClinicalTrials.gov number NCT02330224 . Registered on 28 December 2014.

Socio-economic disadvantage and demographics as factors in stage of colorectal cancer presentation and survival.

BACKGROUND: Colorectal cancer (CRC) is common, and early diagnosis improves outcome. Overseas studies have suggested that low socio-economic status (SES) is related to advanced cancer stage at presentation and reduced survival. The situation in Australia is unclear. This study examines the effect of demographic and SES on CRC stage at presentation and survival in a single tertiary centre. METHODS: Patients undergoing surgical resection for CRC (1 January 2005 to 31 December 2010) were identified, and socio-demographic and histopathological information obtained. Four socio-economic indices using 2006 Australian Census data were assigned by residential postcode. Factors contributing to tumour (T) and American Joint Committee on Cancer (AJCC) stage at presentation and survival were assessed. RESULTS: Five hundred and fifty-seven patients were included. Results did not support a relationship between SES and either advanced stage at presentation or survival. Only one index (economic resources) was related to a more advanced T stage at presentation (P = 0.011); none were related to AJCC stage or survival. No significant relationship was found between an individual's country of birth, language spoken, private insurance or employment status and presenting with a later T or AJCC stage. Age, AJCC and T stage at diagnosis and emergency presentation significantly affected survival on multivariate analysis. CONCLUSION: SES and most demographic factors did not appear to significantly influence CRC stage at presentation and outcome. A focus on obtaining equivalent access to health care both nationally and internationally could prove beneficial in improving outcomes for CRC.

Incidence of discontinuation of angiotensin-converting enzyme inhibitors due to cough, in a primary healthcare centre in Singapore.

INTRODUCTION: The incidence of cough induced by angiotensin-converting enzyme (ACE) inhibitors has been reported to be 5%-20%, with less than half of affected patients requiring discontinuation due to persistent cough. However, the incidence in the local Asian population has not been studied. This study aimed to objectively evaluate the incidence of discontinuation of ACE inhibitors due to cough, in a primary healthcare centre in Singapore. METHODS: We retrospectively reviewed the medical records, both electronic and written, of patients who attended Tampines Polyclinic to identify those who were newly prescribed ACE inhibitors. The written medical records were analysed to identify patients who discontinued the use of ACE inhibitors and to find out the reasons for discontinuation. RESULTS: A total of 424 patients were identified during the study period. Out of the 424 patients, 129 (30.4%) discontinued the use of ACE inhibitors due to cough. Overall, 90 (21.2%) patients who were initially started on ACE inhibitors were eventually switched to angiotensin receptor blockers (ARBs). CONCLUSION: In our cohort, the incidence of discontinuation of ACE inhibitors due to cough is higher than most other studies. The relationship between ethnicity and tolerance of medications should not be underestimated. As there is a high incidence of discontinuation of ACE inhibitors due to cough in the local population, ARBs may be a reasonable substitute as a first-line medication, if clinically indicated.

Limited knowledge of chronic kidney disease among primary care patients--a cross-sectional survey.

BACKGROUND: Kidney disease is the 9th leading cause of death in Singapore. While preventive effects have focused on early detection and education, little is known about the knowledge level of chronic kidney disease (CKD) locally. We seek to evaluate the knowledge of CKD among primary care patients. METHODS: We conducted a cross-sectional survey of a convenience sample of 1520 patients from 3 primary care centers. Those with existing CKD or on dialysis were excluded. Knowledge was assessed based on 7 questions on CKD in the self-administered questionnaire. One point was given for each correct answer with a maximum of 7 points. RESULTS: 1435 completed all 7 questions on CKD. Mean age was 48.9 ± 5.0 (SD) years. 50.9% were male. 62.3% had a secondary and below education and 52.4% had a monthly household income of ≤ $2000. 43.7% had chronic diseases. Mean score was 3.44 ± 1.53 (out of a maximum of 7). Median score was 4. In multivariate logistic regression, being older {>60 years [Odds Ratio (OR) 0.50, 95% Confidence Interval (CI) 0.32-0.79]; 40-60 years (OR 0.62, 95% CI 0.43,0.89)}, less educated [up to primary education (OR 0.33, 95% CI 0.22-0.49)], having a lower monthly household income [

Immunogenicity, reactogenicity and safety of a diphtheria-tetanus-acellular pertussis-inactivated polio and Haemophilus influenzae type b vaccine in a placebo-controlled rotavirus vaccine study.

INTRODUCTION: In recent years, acellular pertussis combination vaccines have facilitated compliance with and coverage of the national immunisation programme in Singapore. This phase-II study (Rota-007) evaluated the immunogenicity, reactogenicity and safety of a DTPa-IPV/Hib combined vaccine when co-administered with a rotavirus vaccine. MATERIALS AND METHODS: A total of 2464 children aged 3 months were vaccinated with DTPa-IPV/Hib together with a randomised 1:3 ratio of either placebo (n=653) or 1 of 3 different formulations of a rotavirus vaccine. Blood samples were collected for immunogenicity analysis 1 month after the third DTPa-IPV/Hib vaccine dose in a subset of subjects (n = 640). Local and general reactogenicity and unsolicited adverse events were recorded during the follow-up after each vaccination. RESULTS: Serological analysis showed >95% response for all antigens in the co-administered DTPa-IPV/Hib vaccine, with no difference between the rotavirus vaccine and placebo groups. No differences in adverse events and reactogenicity were reported in the rotavirus vaccine and placebo groups. Only 0.2% of the subjects reported Grade 3 adverse events. Three subjects (from the vaccine groups) died during the study, which were assessed by the investigators as unrelated to vaccination. No deaths were reported in the placebo group. CONCLUSION: The combined DTPa- IPV/Hib vaccine is safe, well tolerated and highly immunogenic when given alone or coadministered with the rotavirus vaccine for infants in Singapore.

Evaluation of RIX4414, a live, attenuated rotavirus vaccine, in a randomized, double-blind, placebo-controlled phase 2 trial involving 2464 Singaporean infants.

BACKGROUND: At present, no rotavirus vaccine is commercially available for use worldwide. Hence, a live, attenuated monovalent vaccine was developed with human strain RIX4414 (G1P1A P[8] specificity). Vaccination trials involving infants are ongoing in developed and developing countries. METHODS: This study was a randomized, double-blind, placebo-controlled trial conducted at pediatric hospitals and polyclinics in Singapore for the evaluation of the immunogenicity, reactogenicity, and efficacy of 2 oral doses of RIX4414. In total, 2464 healthy infants (who were 11-17 weeks old when the first dose was administered, which is in accordance with the local immunization schedule) were enrolled to receive RIX4414 at 3 concentrations of virus (10(4.7), 10(5.2), or 10(6.1) focus-forming units) or placebo at 1-month intervals, concomitantly with routinely administered infant vaccines. RESULTS: The RIX4414 vaccine was highly immunogenic, and virtually all vaccine recipients (98%-100%) experienced "vaccine take" (i.e., a combined immunogenicity end point based on seroconversion and/or shedding of RIX4414 in postvaccination stool samples) after receipt of 2 doses at all 3 dosage levels. Depending on the virus concentration, the anti-rotavirus IgA seroconversion rate varied from 76% (95% confidence interval [CI], 68%-83%) to 91% (95% CI, 85%-95%). Two doses of RIX4414 were well tolerated, with no increase in high fever, severe diarrhea, or vomiting after either dose or with increased viral concentration, compared with placebo. There was no observed interference with routine vaccinations of infants when RIX4414 was coadministered. The calculated efficacy of RIX4414 against rotavirus gastroenteritis was 82% (P = .046); however, this result was considered to be of limited conclusive value because of the low number of rotavirus gastroenteritis episodes identified during the follow-up period. CONCLUSIONS: The live, attenuated rotavirus vaccine (RIX4414) was well tolerated and highly immunogenic in Singaporean infants. The immunogenicity of routinely administered infant vaccines was not impaired by concomitant administration of RIX4414 vaccine.