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
1 other identifier
interventional
203
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hypertension
Started Apr 2013
Shorter than P25 for not_applicable hypertension
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedFirst Posted
Study publicly available on registry
April 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedJuly 22, 2015
July 1, 2015
1 month
March 28, 2013
July 20, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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 physical activity 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
Study Arms (2)
Usual care
NO INTERVENTIONEducational program and usual cardiovascular prevention.
Nurse-led reminder through email
EXPERIMENTALIn addition to usual care and educational program, the intervention group will also receive email alerts and phone calls from the nurse-care manager (NCM)
Interventions
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- mental illness;
- nursing home institutionalization;
- pregnancy;
- previous cardiovascular major events, non-modifiable cardiovascular risk-factors (i.e. diabetes).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
ASL02Abruzzo
Chieti, Abruzzo, 66100, Italy
Department of Medicine and Aging Sciences, University of Chieti
Chieti, CH, 66100, Italy
Related 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 controlled trial. Int J Nurs Stud. 2014 Jun;51(6):833-43. doi: 10.1016/j.ijnurstu.2013.10.010. Epub 2013 Oct 25.
PMID: 24225325RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giancarlo GC Cicolini, PhD
ASL 02 Abruzzo - Abruzzo Region - Italy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Epidemiology and Public Health
Study Record Dates
First Submitted
March 28, 2013
First Posted
April 4, 2013
Study Start
April 1, 2013
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
July 22, 2015
Record last verified: 2015-07