scholarly journals The Effectiveness of Stroke Riskometer™ in Improving Stroke Risk Awareness in Malaysia: A Study Protocol of a Cluster-Randomized Controlled Trial

2021 ◽  
pp. 1-11
Author(s):  
Zarudin Mat Said ◽  
Kamarul Imran Musa ◽  
Tengku Alina Tengku Ismail ◽  
Anees Abdul Hamid ◽  
Ramesh Sahathevan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Stroke Risk ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Risk Awareness ◽  
Randomized Controlled ◽  
Stroke Awareness ◽  
Risk Probability ◽  
Cluster Randomized

<b><i>Background:</i></b> Stroke is considered the second leading cause of mortality and disability worldwide. The increasing burden of stroke is strong evidence that currently used primary prevention strategies are not sufficiently effective. The Stroke Riskometer<sup>™</sup> application (app) represents a new stroke prevention strategy distinctly different from the conventional high-cardiovascular disease risk approach. <b><i>Objective:</i></b> This proposed study aims to evaluate the effectiveness of the Stroke Riskometer<sup>™</sup> app in improving stroke awareness and stroke risk probability amongst the adult population in Malaysia. <b><i>Methods:</i></b> A non-blinded, parallel-group cluster-randomized controlled trial with a 1:1 allocation ratio will be implemented in Kelantan, Malaysia. Two groups with a sample size of 66 in each group will be recruited. The intervention group will be equipped with the Stroke Riskometer<sup>™</sup> app and informational leaflets, while the control group will be provided with standard management, including information leaflets only. The Stroke Riskometer<sup>™</sup> app was developed according to the self-management model of chronic diseases based on self-regulation and social cognitive theories. Data collection will be conducted at baseline and on the third week, sixth week, and sixth month follow-up via telephone interview or online questionnaire survey. The primary outcome measure is stroke risk awareness, including the domains of knowledge, perception, and intention to change. The secondary outcome measure is stroke risk probability within 5 and 10 years adjusted to each participant’s socio-demographic and/or socio-economic status. An intention-to-treat approach will be used to evaluate these measures. Pearson’s χ<sup>2</sup> or independent <i>t</i> test will be used to examine differences between the intervention and control groups. The generalized estimating equation and the linear mixed-effects model will be employed to test the overall effectiveness of the intervention. <b><i>Conclusion:</i></b> This study will evaluate the effect of Stroke Riskometer<sup>™</sup> app on stroke awareness and stroke probability and briefly evaluate participant engagement to a pre-specified trial protocol. The findings from this will inform physicians and public health professionals of the benefit of mobile technology intervention and encourage more active mobile phone-based disease prevention apps. <b><i>Trial Registration:</i></b> ClinicalTrials.gov Identifier NCT04529681.

Evaluation of a collaborative protocolized approach by community pharmacies and general medical practitioners for an Australian minor ailments scheme: study protocol for a cluster-randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Sarah Dineen-Griffin ◽  
Victoria Garcia Cardenas ◽  
Kylie Williams ◽  
Shalom Isaac Benrimoj
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Care ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Community Pharmacies ◽  
Randomized Controlled ◽  
Minor Ailments ◽  
Cluster Randomized

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

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