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

March 28, 2013
May 10, 2013
April 2013
May 2013   (final data collection date for primary outcome 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01823588 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Nurse-led Reminder Program for the Prevention of Cardiovascular Diseases
Efficacy of a Nurse-led Reminder Program for the Management of the Risk Factors for Cardiovascular Diseases in Hypertensive Patients: a Randomized Controlled Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
  • Hypertension
  • Cardiovascular Disease
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.

  • 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)
    Intervention: Behavioral: Nurse-led reminder through email.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
203
May 2013
May 2013   (final data collection date for primary outcome measure)

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).
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01823588
Nurse led
No
Lamberto Manzoli, Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Not Provided
Principal Investigator: Giancarlo GC Cicolini, PhD ASL 02 Abruzzo - Abruzzo Region - Italy
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP