Nurse-led Program Efficacy on Blood Pressure Control

Hypertension Clinical Trial

Official title:

Efficacy of a Family Nurse-led Program on Accuracy of Blood Pressure Self-measurement: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04681703
• Other study ID #: 11-19-2015
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: September 30, 2017

Study information

• Verified date: December 2020
• Source: Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The diagnosis and control of hypertension depend on accurate measurements of blood pressure (BP); alternative approaches to measuring BP, such as ambulatory blood pressure monitoring or home blood-pressure self-measurement (HBPM), are gaining increasing acceptance in the diagnosis of hypertension and the monitoring of hypertensive patients.To achieve accurate BP measurements at home, measurement guidelines must be closely followed. However, previous studies have shown that patient compliance is in most cases unsatisfactory.The study aims at evaluating the efficacy of a family nurse (FN)-led home blood pressure management (HBPM) training program in improving BP control based on a comparison with routine care and management.

Description:

The quality of HBPM was found to be higher in patients who received some form of training in BP measurement from healthcare professionals than in patients who did not receive training. Although self-estimation of BP may be prone to error, this risk can be minimized through adequate patient education and training that includes simple but nonetheless important recommendations. However, unclear is whether specific training offered by nurses, who frequently have a close relationship with their hypertensive patients, could result higher patient adherence to HBPM recommendations. Therefore, we assume that a specifically tailored training program conducted by a family nurse (FN), when provided in addition to usual care, could improve patient adherence to HBPM recommendations.

Study design: single-blind, multicenter, randomized controlled trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: September 30, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion criteria:

• Clinical diagnosis of hypertension.

• Patients who visited one of two family practice offices located in Chieti or Pescara.

• Speaking and reading Italian.

• Having an active phone number and an email address.

• Providing a signed informed consent.

Exclusion Criteria:

• Mental illness.

• Cognitive impairments.

• Pregnancy.

• Institutionalization (nursing home).

Related Conditions & MeSH terms

• Home Blood Pressure Measurement
• Hypertension

Intervention

Behavioral:
• Nurse-led program on accuracy of blood pressure self-measurement
The training program was performed in accordance with current guidelines and consisted of a 1-h educational session led by one family nurse (FN) tasked with instruction of the patients. During the training program the FN emphasized that since morning and evening blood pressure (BP) values can widely differ, especially in patients taking medications, BP should be measured twice a day, in the morning and at evening, at specific fixed times (between 6:00 am and 9:00 am and between 6:00 pm and 9:00 pm) at least during the first week of monitoring. Thereafter, measurements can be taken before antihypertensive drugs are taken.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in percentage (%) of patients' adherence to the recommendations for corrrect home blood pressure measurement (HBPM) from baseline (T0) to 1 month (T1)	Response assessed using a structured questionnaire specifically designed to evaluate patients'adherence to current Italian guidelines on HBPM	1 month