Department of Community Medicine and School of Public Health, PGIMER, Chandigarh, Chandigarh, India.
Department of Community Medicine and School of Public Health, PGIMER, Chandigarh, Chandigarh, India
BMJ Open. 2021 Jul 1;11(7):e046825. doi: 10.1136/bmjopen-2020-046825.
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.
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.
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.
CTRI/2018/10/016108; Pre-results.
糖尿病（DM）的管理取决于药物治疗的依从性、自我护理和定期随访，以预防并发症和过早死亡。本研究旨在开发和实施基于行为改变理论和模型的糖尿病自我护理干预包，以改善 2 型糖尿病患者的自我护理实践。
这是一项探索性序贯混合方法研究设计，其中定量研究紧随定性研究，用于开发、实施和评估 2 型糖尿病患者自我护理干预包的效果。定性研究方法将用于确定 2 型糖尿病患者自我护理实践的障碍和促进因素，并为开发糖尿病自我护理干预包提供依据。准实验对照研究设计将用于评估 220 名随机选择的 2 型糖尿病患者在干预组和对照组中开发的干预包。使用相同的预验证和结构化问卷，在基线、随访和终点收集每个自我护理活动的数据。差异分析将用于测量在干预前后，两组中不同自我护理实践成分的 2 型糖尿病患者人数的变化。
本研究已获得昌迪加尔 PGIMER 机构伦理委员会的许可（参考号：NK/4538/PhD/226，日期：18.08.18）。试验结果将通过在同行评议期刊上发表文章进行传播。
CTRI/2018/10/016108；预结果。
