- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00133068
Collaboration to Reduce Disparities in Hypertension
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
The objective of this study is to determine the effectiveness and cost-effectiveness of two interventions aimed at reducing barriers to blood pressure (BP) control in an indigent and African-American population. Specifically, we will conduct a randomized controlled trial comparing BP control using either: (1) reimbursing patients for filling prescriptions (reimbursement arm); (2) a computer-based behavioral intervention (behavioral arm); (3) both the reimbursement and behavioral arms (combined arms); or (4) neither.
The ultimate goal of this study is to reduce the incidence of HTN-related CVD among these populations thereby reducing cardiovascular health disparities. Specific aims of the study are to:
test whether receiving money each time the patient fills a prescription for medications improves BP control by a clinically significant amount.
H1: Reimbursing patients for filling prescriptions will significantly improve BP control.
test whether a computer-based behavioral intervention improves BP control by a clinically significant amount.
H2: A computer-based behavioral intervention will significantly improve BP control.
test whether the two interventions are more effective in improving BP control than either alone.
H3: The effect of improving BP control of administering both interventions together will be greater than the sum of the individual effects of each intervention alone.
- examine the relative cost effectiveness of reimbursement for filling prescriptions, a computer-based behavioral intervention, and the combination of the two.
H4: Both interventions will be cost-effective relative to other commonly-covered services.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
Pennsylvania
-
Harrisburg, Pennsylvania, Forenede Stater, 17101
- PinnacleHealth Adult Outpatient Clinics
-
Philadelphia, Pennsylvania, Forenede Stater, 19104
- Veterans Administration Medical Center
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Pittsburgh, Pennsylvania, Forenede Stater, 15240
- VA Pittsburgh Healthcare System
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients of the Philadelphia Veterans Administration Hospital Primary Care Clinic, PinnacleHealth Adult Outpatient Clinics and the VA Pittsburgh Healthcare System who have a diagnosis of hypertension; are currently taking antihypertensive medications; and have elevated blood pressure.
Exclusion Criteria:
- Under 21 years of age
Have a diagnosis of:
- Atrial fibrillation;
- Metastatic cancer;
- End stage renal disease (ESRD) with dialysis;
- Dementia;
- New York Heart Association (NYHA) class IV congestive heart failure (CHF);
- Blind or deaf;
- Other reason for life expectancy of less than 1 year.
- Are currently participating in another experimental study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: 1
Control
|
Ingen indgriben
|
Eksperimentel: 2
Reduction of financial barrier
|
Copay only
|
Eksperimentel: 3
Computer Intervention
|
Computer intervention only
|
Eksperimentel: 4
Reduction of financial barrier and Computer Intervention
|
computer intervention & copay
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Blodtryk
Tidsramme: 6 måneder
|
6 måneder
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Blodtryk
Tidsramme: 12 måneder
|
12 måneder
|
Cost
Tidsramme: 12 months
|
12 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Stephen E. Kimmel, MD, MSCE, University of Pennsylvania
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
- 707850
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Kliniske forsøg med Styring
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