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

NCT06310512 | Not Yet Recruiting

• 1 other identifier: ANZHEN HOSPITOL-LY-04
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Medication Therapy Management

Outcome Measures

Primary Outcomes (1)

• systolic blood pressure

  Change from baseline in mean seated systolic blood pressure at 6 months

  6 months

Secondary Outcomes (9)

• diastolic blood pressure

  6 months

• Change from baseline in mean sitting systolic blood pressure at 3 months

  3 months

• Change from baseline in number of medication-related problems (MRP) at 6 months

  6 months

• Average number of medication-related problems (MRP) resolved after 6 months

  6 months

• The compliance rate of blood pressure after 6 months

  6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: Structured drug therapy management

Non-Intervention group

NO INTERVENTION

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.

Interventions

Structured drug therapy management 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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old, male or female;
• Outpatients diagnosed with primary hypertension who have not received treatment or are receiving antihypertensive medication;
• 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;
• Expected survival \> 12 months;
• Voluntary participation in the trial and signing the informed consent form.

You may not qualify if:

• 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);
• Patients in the acute stage of the disease requiring emergency medical consultation;
• patients with mental disorder, hearing impairment, intellectual disability, aphasia, etc., resulting in the inability to communicate or to comply with the study agreement
• Patients with tumors;
• 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).

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yang Lin

  Beijing Anzhen Hospital

  STUDY DIRECTOR

Central Study Contacts

JuanJuan Wei, MS

CONTACT

01064456609; weijj2005@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: March 15, 2024
• Study Start: May 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)