Nurse-led Program Efficacy on Blood Pressure Control

Sponsor

Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti (Other)

Overall Status

Completed

CT.gov ID

NCT04681703

Collaborator

(none)

170

Enrollment

Arms

12.9

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Home Blood Pressure Measurement	Behavioral: Nurse-led program on accuracy of blood pressure self-measurement	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

170 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Mar 1, 2017

Actual Study Completion Date :

Sep 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group 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).	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.
No Intervention: Conrol group Management of hypertensive patients, usual care: verbal and written instructions during which the family nurse (FN) or general practitioner (GP) advised the patient to follow the recommendations regarding correct HBPM. A written summary of the recommendations was given to all participants by the GP or FN at the end of the training program.

Arm

Intervention/Treatment

Experimental: Intervention group

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).

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.

No Intervention: Conrol group

Management of hypertensive patients, usual care: verbal and written instructions during which the family nurse (FN) or general practitioner (GP) advised the patient to follow the recommendations regarding correct HBPM. A written summary of the recommendations was given to all participants by the GP or FN at the end of the training program.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti

Investigators

Principal Investigator: Giancarlo Cicolini, Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Giancarlo Cicolini, Principal Investigator, Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti

ClinicalTrials.gov Identifier:

NCT04681703

Other Study ID Numbers:

11-19-2015

First Posted:

Dec 23, 2020

Last Update Posted:

Dec 23, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension

Study Results

No Results Posted as of Dec 23, 2020