Nurse-led Program Efficacy on Blood Pressure Control

NCT ID: NCT04681703

Last Updated: 2020-12-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2017-09-30

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.

Conditions

Hypertension; Home Blood Pressure Measurement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti

OTHER

Sponsor Role: lead

Responsible Party

Giancarlo Cicolini

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giancarlo Cicolini

Role: PRINCIPAL_INVESTIGATOR

Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti

References

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.

Reference Type: DERIVED

PMID: 33872417 (View on PubMed)

Other Identifiers

11-19-2015

Identifier Type: -

Identifier Source: org_study_id