Blood Pressure Self Management for Hypertension & Prehypertension Using an Internet Enabled, Automated Self Management Program
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
We propose to conduct a randomized controlled trial of an Internet-enabled, automated self-management program. The study will be carried out through six local sites (offices) of a large employer. 3 sites will be intervention sites and 3 will be control sites.
Subjects enrolled from the intervention sites will receive a blood pressure meter and access to an Internet site where they can view their readings, read educational material regarding hypertension management and receive personalized tips and feedback.
Subjects enrolled from the control sites will have access to a blood pressure monitor located at their workplace but will only be provided with basic written information about hypertension at the start of the trial and will receive no feedback.
The trial will run for 6 months from the time of enrollment and the primary outcome measure will be a change in systolic blood pressure.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Massachusetts
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Boston, Massachusetts, États-Unis, 02114
- Massachusetts General Hospital
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Full-time employees of EMC
- Aged 30 to 65 years at time of enrollment
- Any of the following
- A diagnosis of hypertension as defined by one of the following
- Taking an antihypertensive medication
- Being told at least twice by a physician or other health professional that the subject has high blood pressure†
- A BP > 140/90 detected at screening by the research team on 2 separate occasions.
- A diagnosis of prehypertension as defined by a systolic BP between 120-139 or a diastolic BP between 80-89 detected at screening by the research team on 2 separate occasions
- Access to the Internet at work and / or at home
Exclusion Criteria:
- Inability to self-monitor blood pressure due to musculoskeletal or cognitive impairment
- Known secondary cause of hypertension e.g. renal artery stenosis, Cushing's disease.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Intervention
Internet-based hypertension self-management platform
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An internet platform to display blood pressure readings and provide subjects with automated messages and educational information about hypertension management.
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Comparateur actif: Control
Installation of BP cuff for communal use at the worksite
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Provided BP cuff for communal use at the worksite
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Change in systolic blood pressure.
Délai: 6 months
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6 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Assess whether the intervention increases the motivation and self-efficacy of patients managing blood pressure. Assess patient satisfaction with the intervention. Assess the impact of the intervention on healthcare utilization and expenditure
Délai: 6 months
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6 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Joseph C. Kvedar, MD, Harvard Medical School (HMS and HSDM)
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2006-P-002440
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