Nurse-led Reminder Program for the Prevention of Cardiovascular Diseases

Not Applicable

Completed

• Conditions: Hypertension; Cardiovascular Disease

• Registration Number: NCT01823588
• Lead Sponsor: Università degli Studi 'G. d'Annunzio' Chieti e Pescara

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-28
• Study Start: 2013-04
• Study First Submitted QC: 2013-04-02
• Study First Posted: 2013-04-04
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-20
• Last Update Posted: 2015-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Mean difference between groups in the average reduction in physical activity between baseline and the end of follow-up	6 months
Mean difference between groups in the average reduction in LDL cholesterol between baseline and the end of follow-up	6 months
Mean difference between groups in the average reduction in BMI between baseline and the end of follow-up	6 months

Trial Locations

Locations (2)

ASL02Abruzzo; 🇮🇹 Chieti, Abruzzo, Italy

Department of Medicine and Aging Sciences, University of Chieti; 🇮🇹 Chieti, CH, Italy