Effectiveness of diabetes little helper video intervention on medication adherence among elderly patients with type 2 diabetes mellitus in Henan, China: study protocol for a randomised controlled trial.

INTRODUCTION

In the management of medication adherence in elderly patients with type 2 diabetes mellitus (T2DM), traditional methods such as verbal guidance and written materials may have certain limitations. Therefore, the development of digital intervention measures may play a key role in addressing these shortcomings. The objective of this study is to investigate the effects of Diabetes Little Helper (DLH) video intervention in improving medication adherence among elderly patients with T2DM in Henan province, China.

METHODS AND ANALYSIS

A parallel cluster randomised controlled trial will be applied in the current study. The two hospitals will be randomly divided into a control group and an intervention group, with 68 patients in each arm. Both groups will receive standard care, meanwhile the intervention group will receive an additional DLH video intervention. Data collection is planned at baseline, 1 month after intervention and at 3-month follow-up. Once the study is completed, the control group will also receive the similar video as in the intervention arm to uphold the ethical issues.

ETHICS AND DISSEMINATION

This study has obtained ethical approval from the Institutional Review Board of University Putra Malaysia (JKEUPM-2023-1279) and Henan Provincial People's Hospital (20240107). The research results will also be submitted for publication in peer-reviewed journals.

TRIAL REGISTRATION NUMBER

Chinese Clinical Trial Registry, ChiCTR2400083282.