- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00781365
Home Blood Pressure Telemonitoring and Case Management to Control Hypertension (Hyperlink)
15. mars 2017 oppdatert av: HealthPartners Institute
In this project we develop and implement an intervention to improve hypertension control in a primary care setting that takes advantage of new technology (home blood pressure telemonitoring) and team models of care (pharmacist case management).
The results of the project will have important implications for future efforts to improve care provided to many of the estimated 20 million Americans with uncontrolled hypertension.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Blood pressure (BP) is controlled to recommended levels in only 1 in 3 people with hypertension, and there has been little improvement since the late 1980s, despite advances in evidence to support aggressive hypertension control, and availability of many new and effective antihypertensive drugs.
It is clear that meaningful and sustained improvement in hypertension control will likely require fundamental changes in the current physician-centered office-visit based model of caring for hypertension.
In this project we develop and implement an intervention that takes advantage of new technology and team models of care to improve BP measurement and control, solving the problems that have limited the application of case management approaches to hypertension care improvement.
The study will take place in a diverse population of adults with hypertension cared for in a real-world primary care setting.
The Telemonitoring Intervention (TI) integrates 2 innovative components: First, home BP measures are done using state-of-the-art modem-enabled automated equipment that internally stores and electronically transmits BP data through a simple touch-tone telephone connection to a secure web site.
Second, a pharmacist case manager integrated with the primary care team through a jointly used electronic medical record (EMR) and formulary adjusts antihypertensive therapy using an approved written protocol, under a collaborative practice agreement with physicians.
Treatment decisions are based on home BP data and are discussed and communicated to patients in telephone visits with the pharmacist case manager.
Two-way communication between the pharmacist case manager and the patient's primary care team is assured by using a shared EMR and by additional secure messaging of the results of every pharmacist encounter to the primary care team.
To assess the impact of the TI on hypertension control, patient satisfaction, and costs of care, we will conduct a cluster-randomized trial, assigning 16 primary care clinics and 450 of their nested patients with uncontrolled hypertension to either a Usual Care (UC) control group or TI.
Blood pressure outcomes in both groups will be determined at baseline, 6, 12, 18 and 54 months in an identical and blinded fashion in a research clinic separate from the clinical setting where patients received their medical care.
We hypothesize that guideline BP control will be achieved at 6 months and maintained at 12 months in more than 60% of patients from TI clinics, compared to < 40% in patients from UC clinics.
We will compare satisfaction with care and costs in the TI and UC groups.
The TI has the potential to improve hypertension control for millions of patients, and could be implemented widely in diverse and large patient populations based on performance in this randomized trial.
The results of the project will have important implications for future efforts to improve care provided to many of the estimated 20 million Americans with uncontrolled hypertension.
Studietype
Intervensjonell
Registrering (Faktiske)
450
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Minnesota
-
Minneapolis, Minnesota, Forente stater, 55440
- HealthPartners Institute
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
21 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Age 21 years or more
- Linked using EMR data to a HealthPartners Medical Group primary care clinic
- Within the 12-month period of time prior to screening have had at least 2 primary care outpatient encounters, in the two most recent of which the blood pressure was above Joint National Committee 7 (JNC7) goal (<140/90 mmHg or <130/80 for patients with diabetes or kidney disease).
- Have a measured blood pressure at a research clinic screening visit above the JNC7 goal
Exclusion Criteria:
- Acute coronary syndrome or stroke within the past 3 months
- Class III (marked limitation of physical activity) or IV (symptoms at rest) New York Heart Association heart failure, or known left ventricular ejection fraction (<30%)
- Severe renal dysfunction, with epidermal growth factor receptor (eGFR) ,30 ml/min/1.73 m2 using the abbreviated Modification of Diet in Renal Disease Study (MDRD) equation
- Known secondary causes of hypertension such as coarctation of the aorta, pheochromocytoma, adrenal cortical hypertension or renal vascular hypertension
- Unwillingness to be followed for a period of 18 months
- Pregnancy or unwillingness to use reliable bith control for females of child-bearing age
- Participation in another clinical trial
- Requires an interpreter to communicate with health care providers
- Dementia, mental illness or any condition that would limit ability to give informed consent
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: Control
Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
|
|
Eksperimentell: Telemonitors and pharmacy management
The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure.
Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.
|
Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Blood Pressure Control
Tidsramme: Baseline, 6 months, 12 months, 18 months
|
Percentage of patients with controlled blood pressure at each time point (less than 140/90 mmHg or 130/80 mmHg for patients with kidney disease or diabetes)
|
Baseline, 6 months, 12 months, 18 months
|
Mean Systolic Blood Pressure
Tidsramme: Baseline, 6 months, 12 months, 18 months, 54 months
|
Systolic blood pressure at baseline and 4 time points
|
Baseline, 6 months, 12 months, 18 months, 54 months
|
Mean Diastolic Blood Pressure
Tidsramme: Baseline, 6 months, 12 months, 18 months, 54 months
|
Mean diastolic blood pressure at baseline and 4 time points
|
Baseline, 6 months, 12 months, 18 months, 54 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Karen L Margolis, MD, MPH, HealthPartners Institute
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Margolis KL, Crain AL, Green BB, O'Connor PJ, Solberg LI, Beran M, Bergdall AR, Pawloski PA, Ziegenfuss JY, JaKa MM, Appana D, Sharma R, Kodet AJ, Trower NK, Rehrauer DJ, McKinney Z, Norton CK, Haugen P, Anderson JP, Crabtree BF, Norman SK, Sperl-Hillen JM. Comparison of explanatory and pragmatic design choices in a cluster-randomized hypertension trial: effects on enrollment, participant characteristics, and adherence. Trials. 2022 Aug 17;23(1):673. doi: 10.1186/s13063-022-06611-3.
- Margolis KL, Asche SE, Bergdall AR, Dehmer SP, Maciosek MV, Nyboer RA, O'Connor PJ, Pawloski PA, Sperl-Hillen JM, Trower NK, Tucker AD, Green BB. A Successful Multifaceted Trial to Improve Hypertension Control in Primary Care: Why Did it Work? J Gen Intern Med. 2015 Nov;30(11):1665-72. doi: 10.1007/s11606-015-3355-x.
- Margolis KL, Kerby TJ, Asche SE, Bergdall AR, Maciosek MV, O'Connor PJ, Sperl-Hillen JM. Design and rationale for Home Blood Pressure Telemonitoring and Case Management to Control Hypertension (HyperLink): a cluster randomized trial. Contemp Clin Trials. 2012 Jul;33(4):794-803. doi: 10.1016/j.cct.2012.03.014. Epub 2012 Apr 1.
- Pawloski PA, Asche SE, Trower NK, Bergdall AR, Dehmer SP, Maciosek MV, Nyboer RA, O'Connor PJ, Sperl-Hillen JM, Green BB, Margolis KL. A substudy evaluating treatment intensification on medication adherence among hypertensive patients receiving home blood pressure telemonitoring and pharmacist management. J Clin Pharm Ther. 2016 Oct;41(5):493-8. doi: 10.1111/jcpt.12414. Epub 2016 Jun 30.
- Asche SE, O'Connor PJ, Dehmer SP, Green BB, Bergdall AR, Maciosek MV, Nyboer RA, Pawloski PA, Sperl-Hillen JM, Trower NK, Margolis KL. Patient characteristics associated with greater blood pressure control in a randomized trial of home blood pressure telemonitoring and pharmacist management. J Am Soc Hypertens. 2016 Nov;10(11):873-880. doi: 10.1016/j.jash.2016.09.004. Epub 2016 Sep 25.
- Margolis KL, Asche SE, Bergdall AR, Dehmer SP, Groen SE, Kadrmas HM, Kerby TJ, Klotzle KJ, Maciosek MV, Michels RD, O'Connor PJ, Pritchard RA, Sekenski JL, Sperl-Hillen JM, Trower NK. Effect of home blood pressure telemonitoring and pharmacist management on blood pressure control: a cluster randomized clinical trial. JAMA. 2013 Jul 3;310(1):46-56. doi: 10.1001/jama.2013.6549.
- Kerby TJ, Asche SE, Maciosek MV, O'Connor PJ, Sperl-Hillen JM, Margolis KL. Adherence to blood pressure telemonitoring in a cluster-randomized clinical trial. J Clin Hypertens (Greenwich). 2012 Oct;14(10):668-74. doi: 10.1111/j.1751-7176.2012.00685.x. Epub 2012 Jul 26.
- Margolis KL, Dehmer SP, Sperl-Hillen J, O'Connor PJ, Asche SE, Bergdall AR, Green BB, Nyboer RA, Pawloski PA, Trower NK, Maciosek MV. Cardiovascular Events and Costs With Home Blood Pressure Telemonitoring and Pharmacist Management for Uncontrolled Hypertension. Hypertension. 2020 Oct;76(4):1097-1103. doi: 10.1161/HYPERTENSIONAHA.120.15492. Epub 2020 Aug 31.
- Margolis KL, Asche SE, Dehmer SP, Bergdall AR, Green BB, Sperl-Hillen JM, Nyboer RA, Pawloski PA, Maciosek MV, Trower NK, O'Connor PJ. Long-term Outcomes of the Effects of Home Blood Pressure Telemonitoring and Pharmacist Management on Blood Pressure Among Adults With Uncontrolled Hypertension: Follow-up of a Cluster Randomized Clinical Trial. JAMA Netw Open. 2018 Sep 7;1(5):e181617. doi: 10.1001/jamanetworkopen.2018.1617.
- Annuzzi G, Bozzetto L, Costabile G, Giacco R, Mangione A, Anniballi G, Vitale M, Vetrani C, Cipriano P, Della Corte G, Pasanisi F, Riccardi G, Rivellese AA. Diets naturally rich in polyphenols improve fasting and postprandial dyslipidemia and reduce oxidative stress: a randomized controlled trial. Am J Clin Nutr. 2014 Mar;99(3):463-71. doi: 10.3945/ajcn.113.073445. Epub 2013 Dec 24.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2009
Primær fullføring (Faktiske)
1. oktober 2012
Studiet fullført (Faktiske)
1. oktober 2012
Datoer for studieregistrering
Først innsendt
28. oktober 2008
Først innsendt som oppfylte QC-kriteriene
28. oktober 2008
Først lagt ut (Anslag)
29. oktober 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. april 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. mars 2017
Sist bekreftet
1. mars 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 07116
- 1R01HL090965 (U.S. NIH-stipend/kontrakt)
- 2R01HL090965 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Hypertensjon
-
University Hospital of CologneUkjentNAFLD; Hypertensjon, White-Coat Hypertension, Masked HypertensionTyskland
-
Karolinska InstitutetFullførtWhite Coat Hypertension
-
Clinical Hospital Centre ZagrebEuropean Society of HypertensionUkjentWhite Coat Hypertension | Blodtrykk | LivsstilsrisikoreduksjonIsrael, Hellas, Belgia, Tyskland, Armenia, Østerrike, Bulgaria, Kroatia, Tsjekkia, Estland, Italia, Libanon, Litauen, Nederland, Polen, Portugal, Romania, Serbia, Spania, Sverige, Ukraina, Storbritannia
-
Regional Hospital HolstebroFullførtSunn | White Coat Hypertension | Essensiell hypertensjonDanmark
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Aktiv, ikke rekrutterendeWhite Coat Hypertension | Hypertensjon, viktigForente stater
-
University of Alabama at BirminghamTroy UniversityFullførtHypertensjon | Hypertensjon, motstandsdyktig mot konvensjonell terapi | Ukontrollert hypertensjon | Hypertensjon, hvit pelsForente stater
-
PD Dr. Grégoire WuerznerSwiss National Science FoundationFullførtHypertensjon | Overvekt | White Coat Hypertension | Resistent hypertensjonSveits
-
University Hospital, ToursFullførtPTFE-dekkede stenter versus nakne stenter i TIPS (Transjugulær Intra-hepatisk Porto-systemisk shunt)Cirrhotic Portal HypertensionFrankrike
-
Sun Yat-sen UniversityFullførtHepatocellulært karsinom (HCC) | Cirrhotic Portal HypertensionKina
Kliniske studier på Telemonitors and pharmacy management
-
University of ArkansasNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Rekruttering
-
Dana-Farber Cancer InstituteFullførtKreft | Kjemoterapi-indusert perifer nevropatiForente stater
-
University of ArkansasNational Institute on Minority Health and Health Disparities (NIMHD)RekrutteringType 2 diabetesForente stater
-
University of MichiganNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Fullført
-
Baylor College of MedicineFullførtAngstlidelser | RusmisbruksforstyrrelserForente stater
-
Omada Health, Inc.Palo Alto Medical Foundation; Sutter HealthAvsluttetType 2 diabetesForente stater
-
Université de SherbrookeQuebec Pain Research NetworkFullførtMekanisk korsryggsmerterCanada
-
Karamanoğlu Mehmetbey UniversityKaraman Training and Research HospitalFullført
-
Akdeniz UniversityHar ikke rekruttert ennåEldre mennesker | Katastrofe
-
University of WashingtonFullførtSchizofreni | Bipolar lidelse | Alvorlig psykisk sykdom