Nurse-led Program Efficacy on Blood Pressure Control

NCT04681703 | Completed

• 1 other identifier: 11-19-2015
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension; Home Blood Pressure Measurement

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Conrol group

NO INTERVENTION

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.

Interventions

Nurse-led program on accuracy of blood pressure self-measurement BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti: lead

Related Publications (1)

• Simonetti V, Comparcini D, Tomietto M, Pavone D, Flacco ME, Cicolini G. Effectiveness of a family nurse-led programme on accuracy of blood pressure self-measurement: A randomised controlled trial. J Clin Nurs. 2021 Aug;30(15-16):2409-2419. doi: 10.1111/jocn.15784. Epub 2021 Apr 19.

  PMID: 33872417 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Giancarlo Cicolini

  Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 23, 2020
• Study Start: September 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: September 30, 2017
• Last Updated: December 23, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share