- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00201136
Interventions to Improve Hypertension Control and Reduce Cardiovascular Disease Risk (HIP)
Hypertension Improvement Project (HIP)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
BACKGROUND:
Hypertension affects 25% of adults in the United States and remains a leading cause of heart disease, stroke, and kidney failure. Despite numerous effective treatments, only 25% of people with hypertension are at goal blood pressure (BP). The chronic care model suggests that BP control can be achieved by improving patient self-care and the systems through which care is delivered. Patient self-care efforts should be directed at counteracting the effects of obesity, physical inactivity, poor dietary pattern, and non-adherence to prescribed medications on BP. In addition, efforts should be directed at the use of quality improvement systems that can counteract the well-documented non-adherence of primary care MDs to established clinical practice guidelines. In addition to improving BP control, these approaches can also reduce costs associated with hypertension and its consequences. However, given the resources that would be required to implement such approaches, it is critical that their effectiveness be rigorously established. This controlled study will test the separate and combined effects of a behavioral intervention for patients and a CQI intervention for MDs on BP control. The patient intervention will employ proven behavioral methods for promoting a healthy lifestyle and adherence to medication regimens. The MD intervention will use a CQI approach to provide training, motivation, and feedback on performance in a non-threatening way to promote continuous self-improvement and adherence to clinical practice guidelines.
DESIGN NARRATIVE:
The Hypertension Improvement Project (HIP) is a randomized, controlled study that will test the separate and combined effects of a CQI intervention for MDs and a behavioral intervention for patients on BP control. MDs will be selected from practices in the Duke Primary Care Research Consortium that serve low-income and minority populations. Practices will be randomly assigned to the MD intervention or to the MD control condition. Within these practices, all MDs will receive the same intervention and their patients will be individually randomized to the patient intervention or to the patient usual care condition. The MD intervention consists of the following three main elements: 1) on-line training modules; 2) an evaluation and treatment algorithm for use in the clinic; and 3) a CQI procedure involving assessment of clinical performance measures and feedback to MDs on their adherence to guidelines. The performance data will be collected for 18 months and feedback will be provided to MDs every 3 months. Patients from these practices (approximately 50% women, at least 40% African American, and 90% low-income) will be randomly assigned to patient intervention or usual care. The patient intervention consists of a 6-month behavioral intervention aimed at lifestyle changes to lower BP and promote adherence to prescribed BP medications. BP and other follow-up measurements will be performed at the end of the intervention and a year later (at 6 and 18 months post-randomization). The primary outcome will be the proportion of patients in each treatment group that have adequate BP control at 6 months. BP control is defined by the Joint National Committee 6 (JNC-6) goals (systolic BP less than 140 mm Hg and diastolic BP less than 90 mm Hg for most patients; lower goals for patients with cardiovascular or renal disease, or diabetes). Other outcomes of this study will include BP control at 18 months, MD adherence to national guidelines, and patient adherence to lifestyle recommendations and medication regimens. A cost analysis will also be done. The study will enroll 500 patients in 10 practices (approximately 20 MDs), and will have 80% power to detect an effect size of 0.3 for the primary outcome. The HIP study will test practical interventions for improving hypertension control that can be broadly implemented and can reduce CVD risk.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
North Carolina
-
Durham, North Carolina, Förenta staterna, 27710
- Duke University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Receiving primary care from participating physicians from practices in the Duke Primary Care Research Consortium
- Hypertension
Exclusion Criteria:
- Primary care doctor advises against enrollment
- Pregnant, nursing, or planning pregnancy
- Recent CVD event
- Chronic kidney or liver disease
- Active cancer
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Inget ingripande: MD-C/PT-C
Physician and patient control group.
|
|
Experimentell: MD-I/PT-C
MD CQI-type intervention; Patient control
|
CQI-type intervention for MD adherence to JNC guidelines for BP management
|
Experimentell: MD-C/Pt-I
MD control; patient behavioral intervention
|
Weight loss, DASH dietary pattern, increased physical activity, reduced salt intake, moderation of alchohol intake.
|
Experimentell: MD-I/Pt-I
MD CQI-type intervention; Patient behavioral intervention
|
CQI-type intervention for MD adherence to JNC guidelines for BP management
Weight loss, DASH dietary pattern, increased physical activity, reduced salt intake, moderation of alchohol intake.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Change in systolic blood pressure
Tidsram: 6 months
|
6 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Change in diastolic BP
Tidsram: 6 months
|
6 months
|
Change in BP at 18 months
Tidsram: 18 months
|
18 months
|
Patient and MD adherence to intervention
Tidsram: 6 and 18 months
|
6 and 18 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studiestol: Laura P. Svetkey, Duke University
Publikationer och användbara länkar
Allmänna publikationer
- Svetkey LP, Pollak KI, Yancy WS Jr, Dolor RJ, Batch BC, Samsa G, Matchar DB, Lin PH. Hypertension improvement project: randomized trial of quality improvement for physicians and lifestyle modification for patients. Hypertension. 2009 Dec;54(6):1226-33. doi: 10.1161/HYPERTENSIONAHA.109.134874.
- Dolor RJ, Yancy WS Jr, Owen WF, Matchar DB, Samsa GP, Pollak KI, Lin PH, Ard JD, Prempeh M, McGuire HL, Batch BC, Fan W, Svetkey LP. Hypertension Improvement Project (HIP): study protocol and implementation challenges. Trials. 2009 Feb 26;10:13. doi: 10.1186/1745-6215-10-13.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pro00013310
- R01HL075373 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Hypertoni
-
Pfizer's Upjohn has merged with Mylan to form Viatris...Avslutad
-
NovartisAvslutad
-
NovartisAvslutadMETABOLISKT SYNDROM | HYPERTENSION | PRE-HYPERTENSIONFörenta staterna
-
Centre Chirurgical Marie LannelongueOkändKronisk trombo-embolisk pulmonell hypertension och pulmonell arteriell hypertensionFrankrike
-
NovartisAvslutadHYPERTENSION | HYPERKOLESTEROLEMIFörenta staterna
-
University Hospital, BonnRekryteringKardiomyopatier | Hypertoni, PortalTyskland
-
University Hospital, ToursAvslutadCirrhotic Portal HypertensionFrankrike
-
Assistance Publique - Hôpitaux de ParisAktiv, inte rekryterandeIntrahepatisk icke-cirrhotisk portalhypertoniFrankrike
-
Ain Shams UniversityAvslutad
Kliniska prövningar på MD CQI-type intervention
-
Université de SherbrookeIsabelle Gaboury; Mike Green; Tara Kiran; Janusz Kaczorowski; Maude LabergeRekrytering
-
University of VermontAvslutad
-
Fundacion CITA-alzheimerBiogipuzkoa Health Research InstituteAvslutadKognitiv försämring | Förebyggande | Riskfaktorer för demens | MultidomäninterventionSpanien
-
yu li,MDRekryteringMagnetisk resonanstomografi | Icke-alkoholisk fettleversjukdom | Bariatrisk kirurgiKina
-
Ethnicity and Disease Community Empowerment CenterSteward Carney Hospital; Boston Public Housing AuthorityOkändDiabetes mellitus | Typ II diabetesFörenta staterna
-
PATHBill and Melinda Gates Foundation; Centers for Disease Control and Prevention och andra samarbetspartnersAvslutad
-
Adhera Health, Inc.Novo Nordisk A/S; Hospital Miguel ServetAvslutadDiabetes mellitus, typ 1Spanien
-
FluGen IncAvslutadInfluensa AFörenta staterna
-
Sinovac Biotech Co., LtdAvslutadHand-fot-munsjukdom | Infektion; Viral, enterovirusKina