Blood Pressure Self Management for Hypertension & Prehypertension Using an Internet Enabled, Automated Self Management Program
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention
Internet-based hypertension self-management platform
|
An internet platform to display blood pressure readings and provide subjects with automated messages and educational information about hypertension management.
|
|
Aktiv komparator: Control
Installation of BP cuff for communal use at the worksite
|
Provided BP cuff for communal use at the worksite
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in systolic blood pressure.
Tidsramme: 6 months
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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
Tidsramme: 6 months
|
6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Joseph C. Kvedar, MD, Harvard Medical School (HMS and HSDM)
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2006-P-002440
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