Proposal of a Mixed-Methods Study to Develop and Validate the Malaysian Anti-Hypertensive Agents Compliance Scale in Hypertensive Patients

Abstract Background: There is still insufficient blood pressure control in hypertensive patients although anti-hypertensive medications are highly available. Determinants of compliance and non-compliance with such medications in hypertensive patients have not been well documented. In response, the objective of the present study is twofold: to identify themes of compliance and non-compliance towards anti-hypertensive medications in hypertensive patients (Study 1) and to develop and validate the Malaysian Anti-Hypertensive Agents Compliance Scale (MAACS) (Study 2). Methods: This study has an exploratory mixed-methods design and will be conducted from December 2020 to December 2021. In Study 1, we will recruit hypertensive patients from two selected clinics to participate in a semi-structured interview session. Recruitment of participants will be terminated once thematic saturation is achieved. Coding and thematic analyses will be performed to identify the themes. In Study 2, based on the themes generated from Study 1, we will develop a Malaysian version of the Anti-Hypertensive Agents Compliance Scale (MAACS). Four hundred hypertensive patients will be randomly selected. Of these, data from 200 participants (serving as the calibration sample) will be subjected to exploratory factor analysis and data from 200 participants (serving as the validation sample) will be subjected to confirmatory factor analysis. Factor structure, concurrent validity, and reliability of the MAACS will be statistically tested. Discussion: With the presence of the MAACS, public health officials and health care providers can gather crucial information regarding barriers and facilitators to hypertensive treatment compliance and design effective health promotion programme in an attempt to reduce complications of uncontrolled hypertension.