Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558877
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Effect of a Pharmacist-led Multifaceted Intervention on Treatment Outcomes in Hypertensive Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of a Pharmacist-led Multifaceted Intervention on Treatment Outcomes in Hypertensive Patients a Cluster Randomised Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this cluster randomized controlled trial is to evaluate the effectiveness of a pharmacist-led multifaceted intensive blood pressure intervention on poorly controlled hypertensive patients in phase 1 1 month 3 months 6 months 12 months and phase 2 24 months post randomization
Detailed Description:
This cluster randomized trial is conducted in eight tertiary hospitals of China and we planned to enroll 100 participants at each hospital The eight hospitals will be randomly divided into an intervention group or a control group in a 11 ratio A total of 800 patients with poorly controlled blood pressure aged 18-80 years will be recruited into the study The pharmacist-led multifaceted intervention is comprised of all the following five components 1 Health education lectures on hypertension related knowledge the potential risks of hypertension and guidance on healthy lifestyle etc 2 home blood pressure telemonitoring 3 Medication consultation including the usage dosage precautions and adverse reactions of hypertension drugs 4 Medication reminders remind subjects to take medication on time by Wechat or Messages 5 Formulation of individualized medication regimen efficacy evaluation and drug realignment However the control group received routine hypertension health education standardized blood pressure measurement and regular follow-up
The primary outcome is to assess the change in blood pressure control rate time in target range TTR adherence to antihypertensive medication rate and cardiovascular disease CVDs between the intervention group and the control group from baseline to follow-up at 1 month 3 months 6 months 12 and 24 months post randomization The secondary outcome is to assess the change in the mean systolic and diastolic pressures and the medication appropriateness measured by the medication appropriateness index MAI between the two groups in phase 1 and 2 Meanwhile the BMI alcohol use and smoking will be also assessed in phase 1 and the incidence of hypertension-related adverse events will be assessed in phase 2
The primary outcome is to assess the change in blood pressure control rate time in target range TTR adherence to antihypertensive medication rate and cardiovascular disease CVDs between the intervention group and the control group from baseline to follow-up at 1 month 3 months 6 months 12 and 24 months post randomization The secondary outcome is to assess the change in the mean systolic and diastolic pressures and the medication appropriateness measured by the medication appropriateness index MAI between the two groups in phase 1 and 2 Meanwhile the BMI alcohol use and smoking will be also assessed in phase 1 and the incidence of hypertension-related adverse events will be assessed in phase 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None