Nurse-led Reminder Program for the Prevention of Cardiovascular Diseases

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01823588
• Other study ID #: Nurse led
• Status: Completed
• Phase: N/A
• First received: March 28, 2013
• Last updated: July 20, 2015
• Start date: April 2013
• Est. completion date: May 2013

Study information

• Verified date: July 2015
• Source: Università degli Studi 'G. d'Annunzio' Chieti e Pescara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Hypertension

Intervention

Behavioral:
• Nurse-led reminder through email.
Both groups will receive an educational program and usual care. The educational program will consist of 1-hour sessions, during which the NCM emphasize the importance of blood pressure control and correct measurement, give advice for a correct blood pressure self-measurement; report non-pharmacological strategies for a healthy lifestyle, and instruction on how to fill the daily self-assessment form. Educational program and usual cardiovascular prevention. The educational program will consist of 1-hour sessions, during which the NCM emphasize the importance of blood pressure control and correct measurement, give advice for a correct blood pressure self-measurement; report non-pharmacological strategies for a healthy lifestyle, and instruction on how to fill the daily self-assessment form.

Locations

Country	Name	City	State
Italy	ASL02Abruzzo	Chieti	Abruzzo
Italy	Department of Medicine and Aging Sciences, University of Chieti	Chieti	CH

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 cont — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		6 months	No
Secondary	Mean difference between groups in the average reduction in LDL cholesterol between baseline and the end of follow-up		6 months	No
Secondary	Mean difference between groups in the average reduction in physical activity between baseline and the end of follow-up		6 months	No
Secondary	Mean difference between groups in the average reduction in BMI between baseline and the end of follow-up		6 months	No