Nurse-led Reminder Program for the Prevention of Cardiovascular Diseases

NCT ID: NCT01823588

Last Updated: 2015-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 203 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2013-05-31

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.

Conditions

Hypertension; Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Usual care

Educational program and usual cardiovascular prevention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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)

Group Type: EXPERIMENTAL

Nurse-led reminder through email.

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Lamberto Manzoli

Associate Professor of Epidemiology and Public Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giancarlo GC Cicolini, PhD

Role: PRINCIPAL_INVESTIGATOR

ASL 02 Abruzzo - Abruzzo Region - Italy

Locations

ASL02Abruzzo

Chieti, Abruzzo, Italy

Department of Medicine and Aging Sciences, University of Chieti

Chieti, CH, Italy

Countries

Italy

References

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.

Reference Type: RESULT

PMID: 24225325 (View on PubMed)

Other Identifiers

Nurse led

Identifier Type: -

Identifier Source: org_study_id