Development and evaluation of self-care intervention to improve self-care practices among people living with type 2 diabetes mellitus: a mixed-methods study protocol

INTRODUCTION: The management of diabetes mellitus (DM) depends on medication adherence, self-care and regular follow-up to prevent complications and premature mortality. This study aims to develop and implement the behavioural change theory and model based diabetes self-care intervention package to improve self-care practices among people living with type 2 DM. METHODS AND ANALYSIS: An exploratory sequential mixed-method study design wherein, quantitative follows qualitative will be used to develop, implement and evaluate the effect of diabetes self-care intervention package among people living with type 2 diabetes. The qualitative research method will be used to identify barriers and facilitators for self-care practices among people living with type 2 DM and will also provide the basis for the development of the diabetes self-care intervention package. The quasi-experimental with control study design will be used to evaluate the developed intervention package among 220 randomly selected people living with type 2 diabetes in both intervention and control arms. Baseline, follow-ups and endline data will be collected using same prevalidated and structured questionnaire for each self-care activity. Difference-in-difference analysis will be used to measure for changes in the proportion of people living with type 2 DM doing different component of self-care practices, preintervention and postintervention in both arms. ETHICS AND DISSEMINATION: Permission for conducting the study has been taken from Institutional Ethical Committee of PGIMER, Chandigarh (Ref no. NK/4538/PhD/226, Dated 18.08.18). The findings of the trial will be disseminated through publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: CTRI/2018/10/016108; Pre-results.