Randomisation and masking
dyslipidaemia, NCD, stroke, depression, diabetes
STROKE, HYPERTENSION, DIABETES
Computer generated number was used for simple randomisation to identify potential participants from the KLS appointment list, and those eligible were contacted via telephone by researcher. Familial or blood-related caregivers of stroke patients aged ≥ 18 years old, owns a smartphone and literate in either Malay or English were recruited. Pregnant caregivers or caregivers with possible depression (i.e. respondents screened positive using the Two Questions With Help Questionnaire, TQWHQ) were excluded. Shortlisted participants were contacted by the researcher and briefed about the study. Participants who agreed to participate signed the informed consent document.Participants were asked to provide details of their sociodemographic data (proforma), stroke risk (SRA™, 20 questions) and lifestyle practices (LS7 questionnaires), and were then interviewed by the researcher to verify their risk factors for stroke (i.e. hypertension, diabetes, dyslipidaemia, previous history of stroke), including physical examination (i.e. blood pressure, body mass index) and reviewing blood tests for total cholesterol and fasting blood sugar levels within the last 6 months. The researcher then used the SRA™ to calculate stroke risk and informed study participants about the findings. All participants in the usual care and SRA™ intervention group received standard counselling and explanation about their stroke risk. Once briefed about their stroke risk, they were randomly assigned to either intervention (SRA™) or conventional care group (i.e., education pamphlet from Ministry of Health, MOH).An assistant researcher, who was not part of the study, managed allocation concealment. This involved enrolling participants and assigning them to different treatments using a randomly generated code from sealed envelopes. The main researcher created the code before the study and kept it concealed until participants were recruited after baseline measurements.Due to the nature of the intervention, masking was not possible. Caregivers in the intervention group received the SRA™ which was downloaded onto their smartphones by the researcher during intervention assignment, in addition to the standard health education (pamphlet). The pamphlet, which is authored by the MOH contains general healthy lifestyle advice and did not contain any information or endorsement on usage of app to reduce risk of stroke or NCD (MOH 2012).To prevent contamination of data among participants during the study, caregivers were asked if they were aware or have downloaded any healthcare application on stroke risk reduction prior to the study and during exit visit assessment. Study participants were then assessed three months later (exit visit assessment), during a face-to-face evaluation visit or via telephone by the researcher based on participants’ availability for assessment.