ArticleBMJ open2024
Pre-diabetes virtual health management community (VHMC) intervention and group interaction management model in China: a randomised clinical trial protocol.
Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
introductionIndividuals with pre-diabetes are at high risk for developing type 2 diabetes mellitus (T2DM), which makes them prone to serious complications such as stroke, kidney failure, blindness and lower-limb amputation. Pre-diabetes can be reversed, and lifestyle modification is considered the best intervention method for diabetes prevention. However, it is difficult for individuals with pre-diabetes to maintain a long-term modified healthy lifestyle owing to psychological burnout in daily management over time due to poor adherence. We developed a novel virtual health management community (VHMC) model based on group interaction management. We present the protocol for the VHMC model applied to the pre-diabetic population-a randomised controlled trial (RCT). METHODS AND ANALYSIS: This study will be conducted to determine the effectiveness of the pre-diabetes VHMC-group interaction management model on improving long-term lifestyle intervention adherence to reduce the incidence of T2DM in China. We will conduct a prospective, multicentre, single-blinded, two-arm, RCT, and a total of 706 patients will be recruited. Those randomly assigned to the intervention group will receive group interaction management based on the VHMC platform. Measures of incidence of T2DM, diabetes outcomes, lifestyle modification and psychosocial outcomes will be assessed at baseline, 3, 6, 12, 24 and 36 months. If the VHMC-group interaction management model shows efficacy in improving the self-management of pre-diabetes or metabolic control, similar interventions may be applied to other chronic conditions. The cost-utility analysis of this model may indicate that this platform could be a potentially cost-effective and efficient way to integrate the VHMC platform into the health management of patients with pre-diabetes. ETHICS AND DISSEMINATION: The Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University approved this study (No. RG2023-262-02). The results of this study will be disseminated through conference presentations and peer-reviewed publications. TRIAL REGISTRATION NUMBER: ChiCTR2400081268. Study start: 1 July 2024, completion: 1 December 2026.
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