- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01823588
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Abruzzo
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Chieti, Abruzzo, Italia, 66100
- ASL02Abruzzo
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CH
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Chieti, CH, Italia, 66100
- Department of Medicine and Aging Sciences, University of Chieti
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Nessun intervento: Usual care
Educational program and usual cardiovascular prevention.
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Sperimentale: 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)
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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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
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
Lasso di tempo: 6 months
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6 months
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Mean difference between groups in the average reduction in LDL cholesterol between baseline and the end of follow-up
Lasso di tempo: 6 months
|
6 months
|
Mean difference between groups in the average reduction in physical activity between baseline and the end of follow-up
Lasso di tempo: 6 months
|
6 months
|
Mean difference between groups in the average reduction in BMI between baseline and the end of follow-up
Lasso di tempo: 6 months
|
6 months
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Giancarlo GC Cicolini, PhD, ASL 02 Abruzzo - Abruzzo Region - Italy
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Nurse led
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .