- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT02321618
Cut Your Pressure Too: The Los Angeles Barbershop Blood Pressure Study
Barber-Pharmacist Coordination to Improve Blood Pressure Management in Black Men
African-American men suffer more than most other groups from hypertension (HTN) but often have less access and less contact with doctors. Previous work by the study's Principal Investigator in Dallas, Texas, and Altadena, California, showed that barbershops are an excellent place to identify black men with high blood pressure and to enlist the aid of their barbers as healthcare extenders.
The purpose of this study in Metro Los Angeles (LA) is to compare two types of barber-based patient-centered blood pressure programs to see which type is more effective in improving the customers' high blood pressure. One type emphasizes blood pressure medication and the other type emphasizes lifestyle modification for high blood pressure.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
Uncontrolled hypertension (HTN) is one of the most important causes of premature disability and death among non-Hispanic black men. Indeed, black men have the highest HTN death rate of any U.S. race, ethnic, or gender group, contributing to a lower life expectancy. The age-adjusted HTN-related death rate is 3.3-times higher among black men than white men. To address this major health disparity, the investigators designed a novel community-partnered team approach to improve HTN management among black men and prevent needless strokes, heart attacks, kidney failure, and heart failure.
HTN requires physician (or middle-level provider) interaction to optimize blood pressure (BP) medication; black men have less interaction than black women; and thus far lower rates of HTN treatment (73% vs. 86%) and control (36% vs. 50%). Black-owned barbershops are a uniquely personal setting to discuss health with influential male peers. Barbershop health outreach is well-established, but untested as a vehicle for improving HTN control. Scientific evaluation is crucial to best allocate finite healthcare dollars and avoid promoting a "community health industry" that benefits only the promoters.
Under-treatment of HTN is common in primary care due to competing demands on physicians' time. The best way to improve HTN control is with team-based approaches enlisting pharmacists. They are more accessible than physicians, more knowledgeable about medication, and receive training on patient education. The investigators' new conceptual model links the barber-based intervention to team-based care delivery.
The purpose of this research study is to compare this new conceptual model to another barber-based patient-centered blood pressure program to see which is more effective in improving high blood pressure among Black patrons of African American owned barbershops in LA. Patrons randomized to Group 1 (the new conceptual model) will provide blood pressure readings for patrons aged 35 to 79 years of age and refer those with HTN to a Clinical Pharmacist to work with their doctors in optimizing blood pressure medication.
Patrons of Group 1 shops will also be exposed to role model posters are not intended as recruitment materials, but rather are educational tools that intend to highlight positive experiences of participation. The text of the role model stories will in no way provide statements of the effectiveness of the intervention being evaluated by the present research study. Rather, they are the main health messaging tools needed to promote completion of the program in order to achieve the experiences described. Essentially the document will be used as an intervention tool for peer-based health messaging - stories from real customers in the barbershop modeling target behaviors leading that promote continued participation in the protocol by peers with the hopes of achieving to the detection, treatment, and control of high blood pressure. Each role model story will encourage one of two desired health behaviors of potential subjects with elevated BP: 1) ask the barber to check patients' BP with each haircut, 2) schedule a follow-up visit with the study pharmacist to get patient's blood pressure under control. Large posters in the barbershop will show the model customer, his barber, and the study pharmacist who facilitated the desired behavior change. The model's (participants) own words will be used on the poster.
Group 2 barbershop patrons will be exposed to up-to-date information on high blood pressure and on lifestyle topics for blood pressure and heart health including weight management, healthy cooking, cholesterol lowering, and exercise.
A pre-specified cross-sectional sub study utilized the trial's initial screening population to test for an association between self-reported nocturia (>2 nightly/voids) and elevated daytime (in-barbershop) blood pressure.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
-
-
California
-
Los Angeles, California, Egyesült Államok, 90048
- Cedars-Sinai Medical Center
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- 35 to 79 years of age
- Non-Hispanic Black men
- Long-term/frequent barbershop patronage (barbershop patrons having at least one haircut every 6 weeks in the same barbershop for the past 6 months).
- Systolic BP >140 at 2 screenings on 2 separate days
- Complete set of Baseline Data
Exclusion Criteria:
- Women
- Children
- <35 years of age
- Non-black
- Hispanic ethnicity
- New/infrequent patronage (<8 haircuts at same barbershop in last 12 months)
- Systolic BP <140 at either screening
- Currently receiving cancer chemotherapy
- On Dialysis
- Incomplete baseline data
- Serious Plan to Move in the next 1.5 years
- Plans to be out of the area for > 1 month in the next 1.5 years
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
---|---|
Kísérleti: BP measurement & pharmacy
BP measurements performed by barber, role model poster exposure in barbershop, and BP medication management visits with study pharmacist
|
Blood pressure monitoring by barber, blood pressure medication management by pharmacist, role model posters encouraging program participation
|
Egyéb: BP educational materials
Exposure to hypertension educational materials in barbershop
|
Exposure to hypertension educational materials
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Primary Blood Pressure Outcome - change in systolic blood pressure
Időkeret: 6 months
|
The pre-specified primary outcome was the change in systolic blood pressure from baseline to 6 months follow-up.
|
6 months
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Secondary Blood Pressure Outcome - change in diastolic blood pressure
Időkeret: 6 months
|
The change in diastolic blood pressure from baseline to 6 month follow-up
|
6 months
|
The percentage of participants achieving blood pressure goal
Időkeret: 6 months
|
The percentage of participants who achieved blood pressure goal after 6 months follow-up (140/90,135/85, 130/80)
|
6 months
|
The change in number/type of drug classes prescribed
Időkeret: 6 months
|
The change in number/class of prescription drugs prescribed from baseline to 6 month follow-up
|
6 months
|
Adverse Drug Reactions
Időkeret: 6 months
|
The number and type of adverse drug reactions reported from baseline to 6 month follow-up
|
6 months
|
Self-Rated Health
Időkeret: 6 months
|
The change in self-rated health score from baseline to 6 month follow-up
|
6 months
|
Self-Rated Patient Engagement
Időkeret: 6 months
|
The change in PACIC patient engagement score from baseline to 6 month follow-up
|
6 months
|
Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Extension Study Primary Blood Pressure Outcome - change in systolic blood pressure
Időkeret: 12 months
|
The primary outcome of the extension study is the change in systolic blood pressure from baseline to 12 months follow-up.
|
12 months
|
Extension Study Secondary Blood Pressure Outcome - change in diastolic blood pressure
Időkeret: 12 months
|
The change in diastolic blood pressure from baseline to 12 month follow-up
|
12 months
|
Extension Study Secondary Outcome - the percentage of participants achieving blood pressure goal
Időkeret: 12 months
|
The percentage of participants who achieved blood pressure goal after 12 months follow-up (140/90,135/85, 130/80)
|
12 months
|
Extension Study Secondary Outcome - the change in number/type of drug classes prescribed
Időkeret: 12 months
|
The change in number/class of prescription drugs prescribed from baseline to 12 month follow-up
|
12 months
|
Extension Study Secondary Outcome - adverse drug reactions
Időkeret: 12 months
|
The number and type of adverse drug reactions reported from baseline to 12 month follow-up
|
12 months
|
Extension Study Secondary Outcome - self-rated health
Időkeret: 12 months
|
The change in self-rated health from baseline to 12 month follow-up
|
12 months
|
Extension Study Secondary Outcome - self-rated patient engagement
Időkeret: 12 months
|
The change in PACIC patient engagement score from baseline to 12 month follow-up
|
12 months
|
Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Ronald G Victor, MD, Cedars-Sinai Medical Center
Publikációk és hasznos linkek
Általános kiadványok
- Victor RG, Li N, Blyler CA, Mason OR, Chang LC, Moy NPB, Rashid MA, Weiss JP, Handler J, Brettler JW, Sagisi MB, Rader F, Elashoff RM. Nocturia as an Unrecognized Symptom of Uncontrolled Hypertension in Black Men Aged 35 to 49 Years. J Am Heart Assoc. 2019 Mar 5;8(5):e010794. doi: 10.1161/JAHA.118.010794.
- Victor RG, Blyler CA, Li N, Lynch K, Moy NB, Rashid M, Chang LC, Handler J, Brettler J, Rader F, Elashoff RM. Sustainability of Blood Pressure Reduction in Black Barbershops. Circulation. 2019 Jan 2;139(1):10-19. doi: 10.1161/CIRCULATIONAHA.118.038165.
- Victor RG, Lynch K, Li N, Blyler C, Muhammad E, Handler J, Brettler J, Rashid M, Hsu B, Foxx-Drew D, Moy N, Reid AE, Elashoff RM. A Cluster-Randomized Trial of Blood-Pressure Reduction in Black Barbershops. N Engl J Med. 2018 Apr 5;378(14):1291-1301. doi: 10.1056/NEJMoa1717250. Epub 2018 Mar 12.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- Pro00035347
- 5R01HL117983-02 (Az Egyesült Államok NIH támogatása/szerződése)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
Klinikai vizsgálatok a BP measurement & pharmacy
-
University of MinnesotaMayo Clinic; University of Pennsylvania; University of Alabama at Birmingham; Vanderbilt... és más munkatársakBefejezveMagas vérnyomásEgyesült Államok
-
Hospital General Universitario ElcheBefejezve
-
MGB Biopharma LimitedHammersmith Medicines Research; Innovate UK; Cambridge Regulatory Services; Phases Clinical... és más munkatársakBefejezve
-
University of Missouri-ColumbiaJelentkezés meghívóvalMetabolikus szindróma | Elhízás, morbid | NASH - Nem alkoholos steatohepatitisEgyesült Államok
-
University of IowaBefejezveMagas vérnyomás | AsztmaEgyesült Államok
-
Mercy Health OhioBefejezve
-
Erasme University HospitalBefejezve
-
University of California, DavisJelentkezés meghívóval
-
Activ'insideCIC Inserm 1405, University Hospital Clermont-Ferrand, FranceBefejezveEgészségesFranciaország
-
William Beaumont HospitalsBefejezveCukorbetegség, 2-es típusúEgyesült Államok