Efficacy of Pharmacist Interventions Through the "Medication Therapy Management Pathway in Hypertensive Patients"

NCT ID: NCT06310512

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-06-30

Brief Summary

The goal of this Randomized Controlled Trial is to carry out in adult patients with primary hypertension whose blood pressure control is not up to standard. The main question it aims to answer are:

To explore the effect of pharmacists' implementation of "the medication therapy management pathway in hypertensive patients"on the patients with hypertension.

Participants will receive structured drug treatment management at the first diagnosis. During on-site follow-up in the first, third and sixth months, as well as telephone follow-up in the second week, second and fourth months, patients will be evaluated, corresponding information will be collected and possible interventions will be taken.

Researchers will compare the non intervention group to see if patients' blood pressure will also be reduced without intervention.

Detailed Description

The purpose of this study is to explore the effectiveness, safety, and cost-effectiveness of pharmacists implementing the Drug Treatment Management Pathway in the treatment of hypertension patients. This trial is a prospective, multi-center, randomized, controlled study. We plan to enroll 420 patients with primary hypertension who are over 18 years old and whose blood pressure control is not up to standard. Qualified participants who meet the inclusion and exclusion criteria were randomly divided into an intervention group of 280 cases and a non intervention group of 140 cases in a 2:1 ratio.

Conditions

Hypertension; Medication Therapy Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention group

Intervention group patients will undergo structured drug treatment management at their first visit. During on-site follow-up at 1, 3, and 6 months, as well as telephone follow-up at the second week, 2 and 4 months, the patient's condition will be evaluated, corresponding information will be collected, and possible intervention measures will be taken for the patient.

Group Type: EXPERIMENTAL

Structured drug therapy management

Intervention Type: BEHAVIORAL

Interventions mainly included (1) information collection, clinical assessment, and evaluation of medication regimens; (2) identification of and intervention for medication-related problems; (3) pharmacy instruction and education, and development of personal medication lists; and (4) follow-up and reassessment

Non-Intervention group

For non intervention group patients, pharmacists evaluate the patient's condition and collect corresponding information at the first visit and on-site follow-up at 1, 3, and 6 months, explain the dosage and dosage of drugs to the patient, and remind them of medication contraindications. Necessary intervention measures are taken at the 6th month.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Structured drug therapy management

Interventions mainly included (1) information collection, clinical assessment, and evaluation of medication regimens; (2) identification of and intervention for medication-related problems; (3) pharmacy instruction and education, and development of personal medication lists; and (4) follow-up and reassessment

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years old, male or female;

2. Outpatients diagnosed with primary hypertension who have not received treatment or are receiving antihypertensive medication;

3. Mild to moderate hypertensive patients with substandard blood pressure: home blood pressure >140/90 mmHg at least once in the last month or more, and the average sitting blood pressure in the clinic on the day of enrollment is >140/90 mmHg;

4. Expected survival > 12 months;

5. Voluntary participation in the trial and signing the informed consent form.

Exclusion Criteria

1. Severe hypertension (mean SBP ≥180mmHg, or mean DBP ≥110mmHg), hypertensive emergency or hypertensive sub-emergency (systolic blood pressure >180 mmHg or diastolic blood pressure >120 mmHg);

2. Have a history or diagnosis of secondary hypertension, including but not limited to the following: renal hypertension, renal vascular hypertension, aortic stenosis, pheochromocytoma, Cushing's syndrome, cystic nephropathy, etc., but drug-induced hypertension is not an exclusion criterion;

3. Patients in the acute stage of the disease requiring emergency medical consultation;

4. patients with mental disorder, hearing impairment, intellectual disability, aphasia, etc., resulting in the inability to communicate or to comply with the study agreement

5. Patients with tumors;

6. Any other reasons that the investigator considers unsuitable for participation in the clinical trial that may affect the efficacy and safety evaluation of the study (including, but not limited to, the investigator's judgment that the subject lives far away and cannot be followed up as scheduled).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Anzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lin Yang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yang Lin

Role: STUDY_DIRECTOR

Beijing Anzhen Hospital

Locations

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

JuanJuan Wei, MS

Role: CONTACT

weijj2005@163.com

01064456609

Other Identifiers

ANZHEN HOSPITOL-LY-04

Identifier Type: -

Identifier Source: org_study_id