METHODS AND ANALYSIS: 370 pregnant women (aged 18 years old and above) will be recruited with International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form. Ten clusters (primary care clinics) will be randomly assigned to either PFMT or usual care in a 1:1 ratio by an independent researcher (sealed envelope). The primary outcome will be urinary incontinence, and the secondary outcomes (quality of life; PFMT adherence, psychological status and mobile apps' usability) will be assessed at four measurement time points (t0: baseline) and postintervention (t1: 4 weeks, t2: 8 weeks and t3: 8 weeks postnatal). T-test analysis will determine any significant differences at the baseline between the control and intervention groups. The mixed-model analysis will determine the effectiveness of the intervention at the population-average level for both the primary and secondary outcomes. For the cost-effectiveness analysis, expenditures during the study and 6 months after the intervention will be compared between the groups using the multiway sensitivity analysis. The recruitment planned will be in December 2020, and the planned end of the study will be in August 2021.
ETHICS AND DISSEMINATION: This study protocol was approved by the Ethics Committee for Research Involving Human Subjects, Universiti Putra Malaysia (JKEUPM-2019-368) and Medical Research and Ethics Committee (MREC), Ministry of Health Malaysia, NMRR-19-412-47116 (IIR) with the ANZCTR registration. This study will obtain informed written consent from all the study participants. The results which conform with the Consolidated Standards of Reporting Trials and the Recommendations for Interventional Trials will be published for dissemination in peer-reviewed journals and conference proceedings.
TRIAL REGISTRATION NUMBER: ACTRN12619000379112.
METHOD: The DERS-18 underwent forward-backward translation and assessment of face and content validity. Both Malay version of the DERS-18 and DASS-21 were completed by 701 adolescents (44.4% boys) aged 13 and 14 years old. To assess its dependability, a floor and ceiling effect evaluation and Cronbach's analysis were both performed. A series of confirmatory factor analyses (CFA), bivariate correlation, and regression were performed to evaluate the construct and criterion validity, respectively.
RESULTS: The Malay version of DERS-18, after excluding "Awareness", indicated excellent reliability (Cronbach's α = 0.93), and acceptable internal consistency for each subscale (range of α from 0.63 to 0.82). Floor or ceiling effects were observed at item level and subscale level, but not at total level. CFA results revealed that the Malay version of the DERS-18 bifactor model (excluding "Awareness") portrayed the best construct validity (χ2/df = 2.673, RMSEA = 0.049, CFI = 0.977, TLI = 0.968) compared to a single factor, a correlated factor, and a higher-order factor model. The DERS-18 subscales (except "Awareness") and DERS-18 total scores were significantly correlated with stress, anxiety, and depression in a positive direction (r ranged from 0.62 to 0.64, p < 0.01). The general factor of the DERS-18 and its specific factors ("Clarity", "Goals", and "Non-Acceptance") significantly predicted the symptoms of stress, anxiety, and depression (R2 ranged from 0.44 to 0.46, p < 0.001).
CONCLUSION: The Malay version of the DERS-18, excluding "Awareness", possessed good reliability, construct validity, and criterion validity to assess emotion dysregulation among Malaysian adolescents.
METHODS AND ANALYSES: We will conduct a systematic review of intervention that assess the effect of environmental management on the incidence of dengue and/or entomological indices. We will include any studies that include intervention through environmental management for dengue control, involving environmental modification, environmental manipulation and changes to human behaviour. A comprehensive search will be performed in electronic databases PUBMED, CENTRAL, SCOPUS, Web of Science and relevant research websites such as PROPSERO, WHO ICTRP and ClinicalTrials.gov to identify studies that meet our inclusion criteria. A systematic approach to searching, screening, reviewing and data extraction will be applied based on Preferred Reporting Items for Systematic reviews and Meta-Analysis. Titles, abstract, keywords for eligibility will be examined independently by researchers. The quality of the included studies will be assessed using quality assessment tool for studies with diverse design and Cochrane risk of bias tool. The characteristics of the selected articles will be described based on the study design, types of intervention and outcomes of the study in various countries. These include the types of environmental management intervention methods and the effectiveness of the intervention in reducing dengue cases or incidence and impact on entomological indices.
ETHICS AND DISSEMINATION: We will register this systematic review with the National Medical Research Register, Ministry of Health Malaysia. This protocol also had been registered with the PROSPERO. No ethical approval is necessary, as there will be no collection of primary data. The results will be disseminated though a peer-reviewed publication and conference presentation.
TRIAL REGISTRATION NUMBER: CRD42018092189.
METHODS: This is a prospective, single-centre, single-blind, randomised controlled pilot feasibility study: The Kegel Exercise Pregnancy Training app (KEPT-app) Trial. Sixty-four incontinent pregnant women who attended one primary care clinic for the antenatal follow-up will be recruited and randomly assigned to either intervention or waitlist control group. The intervention group will receive the intervention, the KEPT-app developed from the Capability, Opportunity, Motivation-Behaviour (COM-B) theory with Persuasive Technology and Technology Acceptance Model.
DISCUSSION: This study will provide a fine-tuning for our future randomised control study on the recruitment feasibility methods, acceptability, feasibility, and usability of the KEPT-app, and the methods to reduce the retention rates among pregnant women with UI.
TRIAL REGISTRATION: This study was registered on ClinicalTrials.gov on 19 February 2021 (NCT04762433) and is not yet recruiting.