Nurse-led Reminder Program for the Prevention of Cardiovascular Diseases

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lamberto Manzoli, Università degli Studi 'G. d'Annunzio' Chieti e Pescara
ClinicalTrials.gov Identifier:
NCT01823588
First received: March 28, 2013
Last updated: May 10, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Hypertension
Cardiovascular Disease
Behavioral: Nurse-led reminder through email.

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

Resource links provided by NLM:


Further study details as provided by Università degli Studi 'G. d'Annunzio' Chieti e Pescara:

Primary Outcome Measures:
  • 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean difference between groups in the average reduction in LDL cholesterol between baseline and the end of follow-up [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mean difference between groups in the average reduction in physical activity between baseline and the end of follow-up [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mean difference between groups in the average reduction in BMI between baseline and the end of follow-up [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 203
Study Start Date: April 2013
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual care
Educational program and usual cardiovascular prevention.
Experimental: Nurse-led reminder through email
In addition to usual care and educational program, the intervention group will also receive email alerts and phone calls from the nurse-care manager (NCM)
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.


  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01823588

Locations
Italy
ASL02Abruzzo
Chieti, Abruzzo, Italy, 66100
Department of Medicine and Aging Sciences, University of Chieti
Chieti, CH, Italy, 66100
Sponsors and Collaborators
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Investigators
Principal Investigator: Giancarlo GC Cicolini, PhD ASL 02 Abruzzo - Abruzzo Region - Italy
  More Information

No publications provided

Responsible Party: Lamberto Manzoli, Associate Professor of Epidemiology and Public Health, Università degli Studi 'G. d'Annunzio' Chieti e Pescara
ClinicalTrials.gov Identifier: NCT01823588     History of Changes
Other Study ID Numbers: Nurse led
Study First Received: March 28, 2013
Last Updated: May 10, 2013
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertension
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014