Nurse-led Reminder Program for the Prevention of Cardiovascular Diseases

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of a Nurse-led Reminder Program for the Management of the Risk Factors for Cardiovascular Diseases in Hypertensive Patients: a Randomized Controlled Trial

Conditions
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Hypertension, Cardiovascular Disease

Intervention / Treatment
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* Behavioral: Nurse-led reminder through email.


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Educational program and usual cardiovascular prevention. | |
| Experimental: Nurse-led reminder through email<br>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.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |