Stratified support pattern-based internet-assisted self-management therapy for diabetes mellitus -mild cognitive impairment: a randomized controlled trial protocol

Abstract

Background: Mild cognitive impairment (MCI) associated with diabetes mellitus (DM) is common among older adults, and self-management is critical to controlling disease progression. However, both MCI and DM are heterogeneous diseases, and existing integrated self-management interventions do not consider patient differences. Grouping patients by disease characteristics could help to individualize disease management and improve the use of available resources. The current study sought to explore the feasibility and effectiveness of a stratified support model for DM-MCI patients. Methods: Eighty-four DM-MCI patients will be randomly divided into an intervention group and a control group in a 1:1 ratio. The intervention group will receive a self-management intervention using the stratified support pattern-based internet-assisted therapy (SISMT), while the control group will receive the health manual intervention (HMI). The study recruiter will be blinded to the group allocation and unable to foresee which group the next participant will be assigned to. At the same time, the allocation will be also hidden from the research evaluators and participants. After 12 weeks and 24 weeks, cognitive function, blood glucose, self-management ability, psychological status, health literacy, and self-management behavior of patients in both groups will be measured and compared. Discussion: This study developed a stratified support pattern-based internet-assisted to provide self-management intervention for patients with DM-MCI. The impact of different models and forms of self-management intervention on cognitive function, blood glucose management, and psychological status health literacy and self-management behavior of patients will be assessed. The results of this study will inform related intervention research on the stratified support pattern-based internet-assisted self-management therapy, and help to slow the decline of cognitive function in patients with DM-MCI. Trial registration: ChiCTR2200061991. Registered 16 July 2022.