Nurse-led Program Efficacy on Blood Pressure Control

Not Applicable

Completed

• Conditions: Hypertension; Home Blood Pressure Measurement
• Interventions: Behavioral: Nurse-led program on accuracy of blood pressure self-measurement

• Registration Number: NCT04681703
• Lead Sponsor: Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-09-01
• Primary Completion: 2017-03-01
• Study Completion: 2017-09-30
• Status Verified: 2020-12
• Study First Submitted: 2020-12-17
• Study First Submitted QC: 2020-12-22
• Last Update Submitted: 2020-12-22
• Study First Posted: 2020-12-23
• Last Update Posted: 2020-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

Not provided

Exclusion Criteria

• Mental illness.
• Cognitive impairments.
• Pregnancy.
• Institutionalization (nursing home).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Nurse-led program on accuracy of blood pressure self-measurement	In addition to usual care: a 1-h educational and training program conducted by the family nurse (FN) in a dedicated room of the ambulatory care centers. During the program, the nurse instructed patients on how to self-measure blood pressure (BP) using the BP self-measurement device and on the importance of adequate device maintenance. The intervention was carried out by the FN on a daily basis during outpatient visits of the participants to the general practitioner (GP).

Primary Outcome Measures

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