Nurse-led Program Efficacy on Blood Pressure Control

December 22, 2020 updated by: Giancarlo Cicolini, Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

170

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2016

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

September 30, 2017

Study Registration Dates

First Submitted

December 17, 2020

First Submitted That Met QC Criteria

December 22, 2020

First Posted (ACTUAL)

December 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 23, 2020

Last Update Submitted That Met QC Criteria

December 22, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-19-2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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