Clinical trial NCT04681703: Nurse-led Program Efficacy on Blood Pressure Control
Official title: Efficacy of a Family Nurse-led Program on Accuracy of Blood Pressure Self-measurement: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Home Blood Pressure Measurement
Lead sponsor: Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Change in percentage (%) of patients' adherence to the recommendations for corrrect home blood pressure measurement (HBPM) from baseline (T0) to 1 month (T1)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
name: Giancarlo Cicolini
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.