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Mechanism Exploration and Effect Evaluation of a Tiered Home-Based Pharmaceutical Care Model for Hypertensive Patients in Communities: A Prospective, Multicenter, Randomized Controlled Study

Mechanism Exploration and Effect Evaluation of a Tiered Home-Based Pharmaceutical Care Model for Hypertensive Patients in Communities: A Prospective, Multicenter, Randomized Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120759
Enrollment
Unknown
Registered
2026-03-19
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypertension

Interventions

Intervention group:Triangle Model–Based Stratified Home Pharmaceutical Care Program for Chronic Disease Patients
Control group:Usual care

Sponsors

The Second Affiliated Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 80 years, both males and females are eligible; 2. A confirmed diagnosis of primary hypertension according to the criteria of the National Primary Hypertension Prevention and Management Guideline (2025 Edition): in the absence of antihypertensive medication, clinic systolic blood pressure (SBP) >=140 mmHg and/or diastolic blood pressure (DBP) >=90 mmHg measured on three separate days within 4 weeks; or home blood pressure >=135/85 mmHg. Patients who are treatment-naïve or currently receiving antihypertensive therapy (with continuous medication for >=4 weeks) are eligible; 3. Hypertensive patients with uncontrolled blood pressure: at least one home blood pressure reading >=140/90 mmHg within the past month, and mean seated clinic blood pressure >=140/90 mmHg on the day of enrollment; 4. Expected survival >12 months; 5. Stable clinical condition, clear consciousness, and no communication or comprehension barriers; 6. Willingness to participate in the study and provision of written informed consent.

Exclusion criteria

Exclusion criteria: 1. Hypertensive emergency (systolic blood pressure >=180 mmHg and/or diastolic blood pressure >=120 mmHg) accompanied by new or progressive acute target organ damage; 2. Confirmed secondary hypertension, including but not limited to: renal parenchymal hypertension, renovascular hypertension, aortic coarctation/stenosis, pheochromocytoma, Cushing’s syndrome, polycystic kidney disease, etc. Drug-induced hypertension is not an exclusion criterion; 3. Patients with cognitive impairment, psychiatric disorders, mental illness, hearing impairment, intellectual disability, aphasia, or other conditions that prevent effective communication or adherence to the study protocol; 4. Patients with severe hepatic disease (Child-Pugh class C, or with decompensated cirrhosis, liver failure, etc.), severe renal impairment (chronic kidney disease stage 4 or 5), malignancy, or other critical illnesses that make them unable to tolerate study assessments or participation; 5. Patients concurrently participating in other clinical trials; 6. Patients expected to relocate out of the study community within 6 months or unable to complete the 6-month follow-up; 7. Any other conditions that, in the investigator’s judgment, make the patient unsuitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Blood pressure;

Secondary

MeasureTime frame
Medication Adherence Score;Medication Use Behavior Risk Score;EQ-5D Quality of Life Score;

Countries

China

Contacts

Public ContactZhang Yin

Department of Pharmacy, The Second Affiliated Hospital of Fujian Medical University

zyin1973@163.com+86 133 2857 9972

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026