Clinical trial NCT01823588: Nurse-led Reminder Program for the Prevention of Cardiovascular Diseases
Official title: Efficacy of a Nurse-led Reminder Program for the Management of the Risk Factors for Cardiovascular Diseases in Hypertensive Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Cardiovascular Disease
Lead sponsor: Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A number of strategies have been evaluated to improve the prevention and control of the main cardiovascular (CVD) risk factors. Nursing telephonic and tele-counseling individualized lifestyle educational programs were found to improve blood pressure (BP) control and adherence to healthy lifestyle. This study aims at evaluating for the first time the efficacy of a nurse-led reminder program through email (NRP-e) to improve CVD risk factors among hypertensive adults.

Participants will receive usual care and a guideline-based educational program on BP control and healthy lifestyle habits. Subjects in the NRP-e group will also receive weekly email alerts and phone calls from a nurse care manager for 6 months. Emails contain a reminder program on the compliance with a healthy lifestyle based upon current guidelines for CVD prevention. Follow-up visits will be scheduled at 1, 3 and 6 months after enrollment; randomization will be made centrally and blood samples will be evaluated into a single, accredited laboratory.


Eligibility criteria: Inclusion Criteria:

* to be eligible, all subjects had to be hypertensive (on active treatment for hypertension, or systolic blood pressure ≥ 140 mmHg; or
* diastolic blood pressure ≥ 90 mmHg).
* speaking and reading Italian,
* having a active phone number and an email address, and
* providing a signed informed consent.

Exclusion Criteria:

* mental illness;
* nursing home institutionalization;
* pregnancy;
* previous cardiovascular major events, non-modifiable cardiovascular risk-factors (i.e. diabetes).

Primary outcomes:
measure: The main outcome of the study was the mean difference between groups in the average reduction in systolic and diastolic blood pressure between baseline and the end of follow-up
timeFrame: 6 months
Secondary outcomes:
measure: Mean difference between groups in the average reduction in LDL cholesterol between baseline and the end of follow-up
timeFrame: 6 months
measure: Mean difference between groups in the average reduction in physical activity between baseline and the end of follow-up
timeFrame: 6 months
measure: Mean difference between groups in the average reduction in BMI between baseline and the end of follow-up
timeFrame: 6 months
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: ASL02Abruzzo
state: Abruzzo
city: Chieti
country: Italy
facility: Department of Medicine and Aging Sciences, University of Chieti
state: CH
Study officials:
affiliation: ASL 02 Abruzzo - Abruzzo Region - Italy
name: Giancarlo GC Cicolini, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cicolini G, Simonetti V, Comparcini D, Celiberti I, Di Nicola M, Capasso LM, Flacco ME, Bucci M, Mezzetti A, Manzoli L. Efficacy of a nurse-led email reminder program for cardiovascular prevention risk reduction in hypertensive patients: a randomized controlled trial. Int J Nurs Stud. 2014 Jun;51(6):833-43. doi: 10.1016/j.ijnurstu.2013.10.010. Epub 2013 Oct 25.