Hypertension, diabetes Other
Conditions
Interventions
Participants will be randomly assigned to either the intervention group (free medication group) or the control group (routine management group) in a 1:1 ratio. The randomization sequence will be gener
Sponsors
The People's Government of Gucheng County, Hebei Province
Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older 2. Meeting the diagnostic criteria of the National Guidelines for Primary Prevention and Management of Hypertension or the National Guidelines for Primary Prevention and Management of Diabetes, and having established a chronic disease management record at the local village clinic or community health service center 3. At the start of the study, residents with local county household registration or holding a local residence permit and planning to reside in the area long-term (=5 years), to ensure completion of long-term follow-up 4. No history of significant allergy to the free basic medications, such as anaphylactic shock, urticaria, or severe gastrointestinal intolerance 5. No malignant tumors, and willing to participate and able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding female patients 2. Severe physical illnesses such as cancer 3. Severe cognitive impairment or psychiatric disorders 4. Participation in other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality, defined as the time from randomization to death from any cause, measured using multiple complementary sources to ensure high completeness and accuracy, including: active follow-up records from regular visits by village doctors or general practitioners; data linkage with the national or regional Population Death Registry Information System; data linkage with the local medical insurance claims/settlement database. All suspected death events will be reviewed and adjudicated by an independent, blinded Clinical Endpoint Committee (CEC) according to pre-specified standardized criteria. The date of death will be determined based on the date recorded in the official death certificate or the registry system. Measured at continuously from the date of randomization until the end of the 10-year follow-up period. The primary outcome analysis will be performed at the 10-year time point using restricted mean survival time (RMST). A pre-specified interim analysis will be conducted once all participants have completed 5 years of follow-up, reporting 5-year all-cause mortality as an exploratory outcome to support policy decision-making. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular, hepatic, renal, and other disease-specific mortality rates, defined as death where the primary cause is attributed to cardiovascular, hepatic, renal, or other specified diseases, measured using linkage with the population death registry system and medical insurance databases, supplemented by active follow-up records. All events will be adjudicated by the independent blinded Clinical Endpoint Committee (CEC) using standardized criteria. Measured at 5 and 10 years after randomization;The incidence rate of the renal composite endpoint, defined as the first occurrence of any of the following: progression to end-stage renal disease (ESRD), a sustained decline in estimated glomerular filtration rate (eGFR) of =40% or =50% from baseline, or death due to renal disease, measured using laboratory measurements (eGFR), active follow-up records, and linkage with medical insurance and death registry databases. All potential events will be adjudicated by the independent blinded Clinical Endpoint Committee (CEC). Measured at 5 and 10 years after randomization;The incremental cost-effectiveness ratio: the ratio of the difference in total costs to the difference in effectiveness (measured in quality-adjusted life years, QALYs) between the intervention and control groups. Costs will be assessed from both societal and healthcare system perspectives, including medication costs, outpatient and inpatient care, and other related medical resource utilization. Effectiveness will be measured using quality-adjusted life years (QALYs) derived from utility values collected during follow-up. Measured at 5 and 10 years after randomization;Longitudinal medication adherence trajectory: the proportion of participants categorized as highly adherent (proportion of days covered [PDC] >=80% ) measured using using Generalized Linear Mixed Models (GLMM) longitudinally at 5 and 10 years after randomization;Clinical target achievement rates for blood pressure or glycemic control measured usin | — |
Countries
China
Contacts
Public ContactYuqing Sun
Outcome results
None listed