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This study was approved by the Ethics Committee of Zhejiang University School of Medicine. Because the study involved only anonymized retrospective data and no direct patient contact, informed consent was waived. The reagents and the equipment used are listed in the Table of Materials.
Study design and patient screening
This study used a single-center retrospective cohort design; elderly patients with DN who were treated in Zhejiang University School of Medicine between January 2022 and November 2025 were included. Candidate records were first identified through the hospital information system according to age, admission date, and discharge diagnosis. Eligibility was then checked against the predefined inclusion and exclusion criteria by two investigators, and records with incomplete hospitalization information, missing core laboratory indicators, or unavailable three-month follow-up data were excluded.
Inclusion and exclusion criteria
Inclusion criteria: age ≥60 years; either sex; diagnosis of type 2 diabetes and diabetic nephropathy based on standard clinical, laboratory, and kidney-disease management criteria13; complete hospitalization, treatment, and nursing records; complete follow-up data at three months after discharge; and traceable core laboratory results.
Exclusion criteria: end-stage renal disease, defined as chronic kidney disease (CKD) stage 5; regular hemodialysis or peritoneal dialysis; previous kidney transplantation; severe hepatic insufficiency (Child-Pugh grade B or above); malignant tumor; active autoimmune disease; severe hematologic disease; major cardio-cerebrovascular events within three months before enrollment, including acute myocardial infarction, cerebral infarction, and cerebral hemorrhage; severe systemic infection, septic shock, major trauma, or major surgery-related stress at admission; severe cognitive impairment or psychiatric disease affecting standardized nursing and follow-up; or a missing rate of core clinical data greater than 10%.
Group allocation
A total of 66 eligible patients were included. Because of the retrospective cohort design, no a priori sample-size calculation was performed. The final sample size represented all consecutive eligible patients treated during the predefined study period after application of the inclusion and exclusion criteria and confirmation of complete hospitalization records and three-month follow-up data. Our hospital formally implemented the integrated nursing protocol investigated in this study in January 2024, and this time point was used for grouping. The 31 patients admitted from January 2022 to December 2023 received routine nursing during hospitalization and were assigned to the control group. The 35 patients admitted from January 2024 to November 2025 received the integrated nursing intervention and were assigned to the observation group. Because the two groups were admitted during different periods, crossover of nursing interventions was unlikely. However, this before-and-after grouping strategy introduced potential temporal bias, as changes in hospital practice, medication availability, diabetes management, discharge planning, staffing, follow-up procedures, and cost structures between 2022 and 2025 may have influenced the observed outcomes.
Conventional nursing protocol
Routine nursing was based mainly on standard disease management. It included daily monitoring of fasting and 2-h postprandial blood glucose, blood pressure, heart rate, oxygen saturation, and other vital signs; medication-related nursing according to medical orders for hypoglycemic drugs, renin-angiotensin-aldosterone system (RAAS) inhibitors, lipid-lowering agents, and renoprotective treatment, together with monitoring for adverse drug reactions; unified dietary education on a low-protein diet, with protein intake set at 0.8 g/kg ideal body weight per day and high-quality animal protein accounting for at least 50%, along with salt and fluid restriction; daily recording of 24-h intake and output; weekly assessment of renal function and serum electrolytes; observation of edema and urine output; and reporting of abnormalities in a timely manner. After discharge, patients received verbal health education and one telephone follow-up per month to assess home medication use, dietary control, and compliance with scheduled follow-up. Each telephone follow-up was recorded in the nursing follow-up log and included medication adherence, diet implementation, edema symptoms, urine-output changes, hypoglycemic symptoms, and outpatient review status.
Trinity integrated nursing protocol
The integrated nursing protocol used in the observation group was designed to replace the fragmented approach of routine care. The workflow included five sequential steps: baseline assessment within 24 h after admission, individualized nutrition-volume-electrolyte planning, daily inpatient monitoring and adjustment, discharge education, and three-month post-discharge follow-up. At baseline, nurses recorded body mass index, CKD stage, appetite, dietary intake, edema grade, 24-h intake-output balance, urine output, medication use, and core laboratory indicators. During hospitalization, diet records, fluid intake, output, edema, blood pressure, urine output, and electrolyte results were reviewed according to the nursing checklist. Abnormal findings, including persistent positive fluid balance, worsening edema, reduced urine output, poor dietary intake, hypoalbuminemia, or electrolyte abnormality, were reported to the treating physician or clinical nutrition service for adjustment. Before discharge, patients and caregivers received written instructions on protein intake, low-phosphorus food choices, salt and fluid restriction, body-weight monitoring, warning symptoms, medication adherence, and follow-up appointments, and follow-up records were maintained for three months after discharge. It was a multicomponent nursing package that combined individualized nutritional guidance, volume management, electrolyte monitoring, follow-up education, and home-care support. The nutritional component was carried out by ward nurses under nephrologist-approved dietary prescriptions, with consultation from the clinical nutrition service when patients had poor intake, evident malnutrition risk, marked hypoalbuminemia, uncontrolled edema, or recurrent electrolyte disturbance. At admission, nurses assessed body mass index, chronic kidney disease stage, appetite, usual diet, serum albumin, prealbumin, hemoglobin, transferrin, urinary protein, edema grade, 24-h intake-output balance, and serum electrolyte levels. Daily nursing tasks included diet-record review, reinforcement of protein-energy targets, education on high-quality low-phosphorus protein choices, fluid and sodium guidance, monitoring of edema and urine output, and timely reporting of abnormal nutritional or electrolyte results for medical or nutritional adjustment. A schematic overview of the protocol is shown in Figure 1. The intervention was initiated within 24 h after admission, continued throughout hospitalization, and was maintained for three months after discharge. Protocol adherence was checked using admission assessment forms, daily nursing checklists, discharge education forms, and follow-up logs. The three-month endpoint was selected because nutritional correction, volume stabilization, electrolyte adjustment, renal-function monitoring, adverse events, quality of life, and medical costs require repeated assessment after discharge. This timeframe is also consistent with recent nutritional and chronic kidney disease management literature, in which approximately twelve weeks or three months is commonly used to evaluate short-term clinical and nutritional responses.
Outcome assessment
Assessments were performed before intervention (at admission) and again three months after intervention. The primary outcomes were nutritional protein-related indicators at three months, including serum albumin, prealbumin, hemoglobin, and transferrin. Secondary outcomes included volume load-related indicators, electrolyte target attainment, renal function-related indicators, adverse events, all-cause readmission, quality-of-life scores, and health economic indicators. Three milliliters of fasting venous blood were collected from the cubital vein in the morning, and serum was separated by centrifugation at 1505 × g. for 10 min at room temperature before analysis. Measured indicators included serum albumin (ALB), prealbumin (PA), hemoglobin (HGB), and transferrin (TRF). Volume load-related indicators included 24-h fluid intake-output difference, BNP level, and edema severity score. The 24-h intake-output difference was calculated as total recorded fluid intake minus total recorded output within the same 24-h period. Edema severity was scored as 0 for no edema, 1 for mild ankle or pedal edema, 2 for edema extending to the lower leg, and 3 for generalized edema or obvious sacral edema. Electrolyte-related indicators were defined as the rates of achieving target values for serum potassium, sodium, calcium, phosphorus, and bicarbonate during the three-month intervention period, according to the reference ranges used by the hospital laboratory. Renal function-related indicators, estimated glomerular filtration rate (eGFR), serum creatinine (Scr), and 24-h urinary total protein (24-h UTP), were measured before intervention and at the follow-up endpoint.
Safety assessment
Clinical adverse events occurring within three months after intervention were recorded when documented in the medical record by the treating physician, including acute left heart failure, hyperkalemia, acute kidney injury, pulmonary infection, and severe hypoglycemia. The all-cause readmission rate was also documented14.
Quality-of-life assessment
Quality of life was assessed before intervention and again at the follow-up endpoint using the 36-Item Short Form Health Survey (SF-36)15. The scale includes eight dimensions: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Each dimension is scored on a 0–100 scale, with higher scores indicating better quality of life.
Health economic evaluation
Relevant data were obtained from the hospital information system (HIS) and follow-up records, including hospital stay during the index admission, total hospitalization cost, and outpatient cost during the three-month follow-up period. Based on these data, the per-capita total medical cost was calculated for each group (per capita total medical cost was calculated as the sum of hospitalization cost and outpatient cost during the three-month follow-up period for each patient). The cost-effectiveness ratio (CER) was then calculated using the change in ALB before and after intervention as the effect indicator.
Statistical analysis
All data were analyzed using SPSS 26.0. Quantitative data with a normal distribution are expressed as mean ± standard deviation (χ ± s); between-group comparisons were performed using the independent-samples t-test, and within-group comparisons before and after intervention were performed using the paired t-test. Quantitative data without a normal distribution are expressed as median (interquartile range) [M (P25, P75)] and were compared using the Mann-Whitney U test. Categorical data are expressed as the number of cases (percentage) [n (%)] and were compared using the χ2 test or Fisher’s exact test where appropriate. All tests were two-sided, with α = 0.05 regarded as statistically significant.