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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 October 02, 2014