Pragmatic, multicentre, randomised controlled trial of a Hospital-Community-Home Tiered Transitional Care (HCH-TTC)...

Type 2 Diabetes Mellitus (T2DM) and its complications significantly increase the risk of premature mortality and disability among patients, placing a considerable burden on socioeconomic development. Evidence has shows that effective transitional care can improve health outcomes for patients with T2DM. However, T2DM transitional care faces challenges including service discontinuity, communication breakdowns and a lack of personalised design, leading to potential issues of undertreatment and overtreatment, increasing the risk of improper blood sugar management. To address these challenges, our research team developed the Hospital-Community-Home Tiered Transitional Care (HCH-TTC) programme for patients with T2DM, aiming to evaluate its effectiveness and feasibility through a randomised controlled trial (RCT).

The multicentre, pragmatic, double-blind RCT will enrol 180 patients with T2DM from the Jinqiao Medical Union in Pudong New Area, Shanghai, China. Participants will be randomly assigned to either the experimental group or the control group. The experimental group will participate in a 6-month HCH-TTC programme, which provides personalised transitional care strategies tailored to patients' evolving health conditions and nursing needs. This tiered management approach includes follow-up, health education, personalised guidance and health monitoring, with variations in intensity, frequency and type based on individual requirements. The control group will receive Hospital-Community-Home Routine Transitional Care programme, consisting of routine follow-up, health education and health monitoring during the same period. Data collection will be conducted at baseline, 1 month postintervention, 3 months and 6 months. The primary outcomes are glycated haemoglobin (HbA1c). Secondary outcomes include fasting plasma glucose (FPG), 2-hour postprandial blood glucose (2hPPG), diabetes knowledge level, diabetes self-management ability, diabetes treatment adherence, nursing service satisfaction, diabetes complications rate and unplanned readmission rate. Statistical analysis will employ independent sample t-tests and repeated measures analysis of variance.

The Gongli Hospital Ethics Committee (GLYY1s2021-010) approved the study. Results will be disseminated through publication in a peer-reviewed journal.

Chinese Clinical Trial Registry ChiCTR2200063322.