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Completed

NCT Number: NCT01823588

Nurse-led Reminder Program for the Prevention of Cardiovascular Diseases

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.

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Key information

Conditions

Hypertension Cardiovascular Disease Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ASL02Abruzzo, Chieti, Abruzzo, Italy

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Nurse-led reminder through email.

Behavioral

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.

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

    Time frame: 6 months

Secondary outcomes

  1. Mean difference between groups in the average reduction in LDL cholesterol between baseline and the end of follow-up

    Time frame: 6 months

  2. Mean difference between groups in the average reduction in physical activity between baseline and the end of follow-up

    Time frame: 6 months

  3. Mean difference between groups in the average reduction in BMI between baseline and the end of follow-up

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 4, 2013
Registry last updated
Jul 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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