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Nurse-led Program Efficacy on Blood Pressure Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04681703
Recruitment Status : Completed
First Posted : December 23, 2020
Last Update Posted : December 23, 2020
Sponsor:
Information provided by (Responsible Party):
Giancarlo Cicolini, Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : September 1, 2016
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Family Issues

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04681703


Sponsors and Collaborators
Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
Investigators
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Principal Investigator: Giancarlo Cicolini Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: December 23, 2020    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases