Community Support and Mobile Apps to Help Black Women Control High Blood Pressure After Pregnancy (PRIME CARE)
19 mei 2026 bijgewerkt door: University of Nebraska
Postpartum Remote Monitoring and Integration of Mobile Health With Engagement From Community Health Workers for Regulating Elevated Blood Pressure
The goal of this randomized clinical trial is to evaluate the effectiveness of a collaborative care intervention, consisting of remote blood pressure monitoring and support from community health workers, in improving blood pressure control and reducing postpartum complications among Black women with hypertensive disorders of pregnancy (HDP).
The primary objectives are to determine whether the intervention leads to improved blood pressure control at 12 months postpartum compared to standard care, and whether it reduces the incidence of serious maternal morbidity, including hospitalizations and cardiovascular events.
Secondary objectives include examining whether patient activation and trust in the healthcare system mediate the relationship between the intervention and clinical outcomes.
Participants will be enrolled at approximately 6 weeks postpartum and randomized to either the collaborative care intervention or standard postpartum care.
All participants will self-monitor blood pressure using a provided device, receive guidance on hypertension management, and complete study assessments at multiple time points.
Participants assigned to the intervention arm will additionally receive ongoing support from community health workers, including health education, care coordination, and assistance with healthcare navigation.
Clinical outcomes and patient-reported measures will be assessed over a 12-month follow-up period.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
404
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Sajid Shahul, MD, PhD
- Telefoonnummer: 773-398-2956
- E-mail: sshahul@unmc.edu
Studie Contact Back-up
- Naam: Mridula Ghotane, MPH
- Telefoonnummer: 445-260-9532
- E-mail: mghotane@unmc.edu
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- Black/ African American patients
- Age: 19 and 50 years of age
- Diagnosis: Hypertension Disorders of Pregnancy
- Enrolled in STAMPP-HTN for first 6 weeks postpartum
Exclusion Criteria:
- Age: <19 years
- Significant Kidney or Liver disease that may limit antihypertensive medication adjustment
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Collaborative Care Intervention
Participants assigned to this arm will receive a collaborative care intervention that includes home blood pressure monitoring using a provided device and support from community health workers.
The intervention includes education on hypertension management, assistance with care coordination, and support with healthcare navigation.
Participants will regularly measure blood pressure and receive ongoing guidance throughout the 12-month postpartum follow-up period.
|
Bluetooth-enabled Remote Patient Monitoring (RPM) with algorithm-driven Community Health Worker (CHW) support.
CHWs provide support (averaging 2.3 contacts/week) to facilitate medication titration and address social determinants of health.
Treatment follows a standardized protocol using guideline-directed medical therapy targeting a blood pressure of <130/80 mmHg.
|
|
Actieve vergelijker: Standard Postpartum Care
Participants assigned to this arm will receive standard postpartum care.
In addition, participants will be provided with a home blood pressure monitoring device and instructed to measure their blood pressure regularly.
No additional community health worker support will be provided.
|
Traditional clinical management consisting of manual blood pressure monitoring and clinic-based medication titration.
Treatment follows the same standardized protocol as the intervention arm, using guideline-directed medical therapy targeting a blood pressure of <130/80 mmHg.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Blood Pressure Control (BP <130/80 mmHg)
Tijdsspanne: Baseline (6 weeks) postpartum to 12 months postpartum
|
Primary endpoint - The proportion of patients achieving a target blood pressure of less than 130/80 mmHg.
Blood pressure will be analyzed both as a dichotomous variable (normal <130/80 mmHg vs. elevated) and as a continuous variable (mean systolic and diastolic readings).
|
Baseline (6 weeks) postpartum to 12 months postpartum
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Patient Activation Measure (PAM-13)
Tijdsspanne: At Baseline (6 weeks) postpartum, 6 months postpartum and 12 months (1 year) postpartum
|
Evaluation of survey-based mechanisms of action to determine if they mediate the impact of the Collaborative Care intervention on blood pressure outcome.
It assesses patient engagement and activation.
A 13-item survey instrument with scores ranging from a minimum of 0 to a maximum of 100.
Higher scores indicate a better outcome (greater patient engagement and activation).
|
At Baseline (6 weeks) postpartum, 6 months postpartum and 12 months (1 year) postpartum
|
|
Morisky Medication Adherence Scale (MMAS-8)
Tijdsspanne: At Baseline (6 weeks) postpartum, 6 months postpartum, and 12 months (1 year) postpartum.
|
A survey-based mechanism of action evaluated via an 8-item self-report survey scale to determine if it mediates the impact of the Collaborative Care intervention on blood pressure outcome.
It measures medication adherence behavior.
Scores range from a minimum of 0 to a maximum of 8, where higher scores indicate a better outcome (higher medication adherence).
Scores are categorized into low (<6), medium (6 to <8), and high (8) adherence.
|
At Baseline (6 weeks) postpartum, 6 months postpartum, and 12 months (1 year) postpartum.
|
|
Trust in Physician Scale
Tijdsspanne: At Baseline (6 weeks) postpartum, 6 months postpartum, and 12 months (1 year) postpartum.
|
An 11-item exploratory survey instrument used to evaluate trust in the health care system and determine if it mediates the impact of the Collaborative Care intervention on blood pressure outcome.
Scores range from a minimum of 11 to a maximum of 55, where higher scores indicate a better outcome (greater trust in the healthcare provider).
|
At Baseline (6 weeks) postpartum, 6 months postpartum, and 12 months (1 year) postpartum.
|
|
Severe Maternal Morbidity (SMM) Composite Rate
Tijdsspanne: Baseline (6weeks) postpartum to 12 months (1 year) postpartum
|
Composite Endpoint - Incidence rates of severe maternal morbidity events to assess the efficacy of the Collaborative Care model in reducing overall maternal risk.
This composite variable tracks the occurrence of any unplanned emergency department (ED) visit, unplanned hospitalization, or the presence of a severe morbidity event.
Severe morbidity events are strictly defined as the clinical occurrence of severe hypertension, acute heart failure, pulmonary edema, eclampsia, acute renal failure, shock, sepsis, cardiac arrest, arrhythmias, myocardial infarction, pulmonary embolism, stroke, or death.
|
Baseline (6weeks) postpartum to 12 months (1 year) postpartum
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Sajid Shahul, MD, PhD, Department of Anesthesia, University of Nebraska Medical Center, Omaha, NE, USA
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
- Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.
- Fritz MS, Mackinnon DP. Required sample size to detect the mediated effect. Psychol Sci. 2007 Mar;18(3):233-9. doi: 10.1111/j.1467-9280.2007.01882.x.
- Hibbard JH, Mahoney ER, Stock R, Tusler M. Do increases in patient activation result in improved self-management behaviors? Health Serv Res. 2007 Aug;42(4):1443-63. doi: 10.1111/j.1475-6773.2006.00669.x.
- Brownstein JN, Chowdhury FM, Norris SL, Horsley T, Jack L Jr, Zhang X, Satterfield D. Effectiveness of community health workers in the care of people with hypertension. Am J Prev Med. 2007 May;32(5):435-47. doi: 10.1016/j.amepre.2007.01.011.
- Royston P, Parmar MK. The use of restricted mean survival time to estimate the treatment effect in randomized clinical trials when the proportional hazards assumption is in doubt. Stat Med. 2011 Aug 30;30(19):2409-21. doi: 10.1002/sim.4274. Epub 2011 May 25.
- Anderson LA, Dedrick RF. Development of the Trust in Physician scale: a measure to assess interpersonal trust in patient-physician relationships. Psychol Rep. 1990 Dec;67(3 Pt 2):1091-100. doi: 10.2466/pr0.1990.67.3f.1091.
- Hameed AB, Lawton ES, McCain CL, Morton CH, Mitchell C, Main EK, Foster E. Pregnancy-related cardiovascular deaths in California: beyond peripartum cardiomyopathy. Am J Obstet Gynecol. 2015 Sep;213(3):379.e1-10. doi: 10.1016/j.ajog.2015.05.008. Epub 2015 May 13.
- Kangovi S, Mitra N, Norton L, Harte R, Zhao X, Carter T, Grande D, Long JA. Effect of Community Health Worker Support on Clinical Outcomes of Low-Income Patients Across Primary Care Facilities: A Randomized Clinical Trial. JAMA Intern Med. 2018 Dec 1;178(12):1635-1643. doi: 10.1001/jamainternmed.2018.4630.
- Bluemke DA, Kronmal RA, Lima JA, Liu K, Olson J, Burke GL, Folsom AR. The relationship of left ventricular mass and geometry to incident cardiovascular events: the MESA (Multi-Ethnic Study of Atherosclerosis) study. J Am Coll Cardiol. 2008 Dec 16;52(25):2148-55. doi: 10.1016/j.jacc.2008.09.014.
- VanderWeele TJ, Vansteelandt S. Mediation Analysis with Multiple Mediators. Epidemiol Methods. 2014 Jan;2(1):95-115. doi: 10.1515/em-2012-0010.
- Hauspurg A, Lemon L, Cabrera C, Javaid A, Binstock A, Quinn B, Larkin J, Watson AR, Beigi RH, Simhan H. Racial Differences in Postpartum Blood Pressure Trajectories Among Women After a Hypertensive Disorder of Pregnancy. JAMA Netw Open. 2020 Dec 1;3(12):e2030815. doi: 10.1001/jamanetworkopen.2020.30815.
- Howell EA. Reducing Disparities in Severe Maternal Morbidity and Mortality. Clin Obstet Gynecol. 2018 Jun;61(2):387-399. doi: 10.1097/GRF.0000000000000349.
- Cairns AE, Tucker KL, Leeson P, Mackillop LH, Santos M, Velardo C, Salvi D, Mort S, Mollison J, Tarassenko L, McManus RJ; SNAP-HT Investigators. Self-Management of Postnatal Hypertension: The SNAP-HT Trial. Hypertension. 2018 Aug;72(2):425-432. doi: 10.1161/HYPERTENSIONAHA.118.10911. Epub 2018 Jul 2.
- Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):e13-e115. doi: 10.1161/HYP.0000000000000065. Epub 2017 Nov 13. No abstract available.
- Islam NS, Wyatt LC, Ali SH, Zanowiak JM, Mohaimin S, Goldfeld K, Lopez P, Kumar R, Beane S, Thorpe LE, Trinh-Shevrin C. Integrating Community Health Workers into Community-Based Primary Care Practice Settings to Improve Blood Pressure Control Among South Asian Immigrants in New York City: Results from a Randomized Control Trial. Circ Cardiovasc Qual Outcomes. 2023 Mar;16(3):e009321. doi: 10.1161/CIRCOUTCOMES.122.009321. Epub 2023 Feb 23.
- Health IDoP. llinois Maternal Morbidity and Mortality Report: October 2023; 2023 [01082024]. Available from: https://dph.illinois.gov /content/dam/soi/en/web/idph/publications/idph/topics-and-services/life-stages-populations/ maternal-child-family-health-services/maternal-health/mmmr/maternal-morbidity-mortalityreport2023.pdf.
- AHA. Postpartum Systems of Care Recommendations. https://wwwheartorg/-/media/files /professional/quality-improvement/maternal-health/recommendationsformatted. 2024.
- Assistant Secretary for Public Affairs (ASPA) DoHaHSH. Strengthening Maternal Health. Available from: https://www.hhs.gov/healthcare/maternal-health/index.html.
- Roderick J. A. Little DBR. Statistical Analysis with Missing Data 2002.
- Patricia M. Grambsch TMT. Proportional Hazards Tests and Diagnostics Based on Weighted Residuals. Biometrika, Vol 81, No 3 (Aug, 1994), pp 515-526 (12 pages).
- Kaplan EL, & Meier, P. . Nonparametric Estimation from Incomplete Observations. Journal of the American Statistical Association. 1958.
- Cox DR. Regression Models and Life-Tables Journal of the Royal Statistical Society: Series B (Methodological), Volume 34, Issue 2.
- Karrison T. Data editing in a clinical trial. Control Clin Trials. 1981 May;2(1):15-29. doi: 10.1016/0197-2456(81)90055-6.
- Shahul S, Ramadan H, Mueller A, Nizamuddin J, Nasim R, Lopes Perdigao J, Chinthala S, Tung A, Rana S. Abnormal mid-trimester cardiac strain in women with chronic hypertension predates superimposed preeclampsia. Pregnancy Hypertens. 2017 Oct;10:251-255. doi: 10.1016/j.preghy.2017.10.009. Epub 2017 Oct 23.
- Shahul S, Ramadan H, Nizamuddin J, Mueller A, Patel V, Dreixler J, Tung A, Lang RM, Weinert L, Nasim R, Chinthala S, Rana S. Activin A and Late Postpartum Cardiac Dysfunction Among Women With Hypertensive Disorders of Pregnancy. Hypertension. 2018 Jul;72(1):188-193. doi: 10.1161/HYPERTENSIONAHA.118.10888. Epub 2018 May 29.
- Shahul S, Medvedofsky D, Wenger JB, Nizamuddin J, Brown SM, Bajracharya S, Salahuddin S, Thadhani R, Mueller A, Tung A, Lang RM, Arany Z, Talmor D, Karumanchi SA, Rana S. Circulating Antiangiogenic Factors and Myocardial Dysfunction in Hypertensive Disorders of Pregnancy. Hypertension. 2016 Jun;67(6):1273-80. doi: 10.1161/HYPERTENSIONAHA.116.07252. Epub 2016 Apr 25.
- Karrison TG. Use of Irwin's restricted mean as an index for comparing survival in different treatment groups--interpretation and power considerations. Control Clin Trials. 1997 Apr;18(2):151-67. doi: 10.1016/s0197-2456(96)00089-x.
- VanderWeele TJ. Mediation Analysis: A Practitioner's Guide. Annu Rev Public Health. 2016;37:17-32. doi: 10.1146/annurev-publhealth-032315-021402. Epub 2015 Nov 30.
- Ding P, Vanderweele TJ. Sharp sensitivity bounds for mediation under unmeasured mediator-outcome confounding. Biometrika. 2016 Jun;103(2):483-490. doi: 10.1093/biomet/asw012. Epub 2016 Apr 30.
- Jacobs JA, Derington CG, Zheutlin AR, King JB, Cohen JB, Bucheit J, Kronish IM, Addo DK, Morisky DE, Greene TH, Bress AP. Association Between Self-Reported Medication Adherence and Therapeutic Inertia in Hypertension: A Secondary Analysis of SPRINT (Systolic Blood Pressure Intervention Trial). J Am Heart Assoc. 2024 Feb 6;13(3):e031574. doi: 10.1161/JAHA.123.031574. Epub 2024 Jan 19.
- Boulware LE, Ephraim PL, Hill-Briggs F, Roter DL, Bone LR, Wolff JL, Lewis-Boyer L, Levine DM, Greer RC, Crews DC, Gudzune KA, Albert MC, Ramamurthi HC, Ameling JM, Davenport CA, Lee HJ, Pendergast JF, Wang NY, Carson KA, Sneed V, Gayles DJ, Flynn SJ, Monroe D, Hickman D, Purnell L, Simmons M, Fisher A, DePasquale N, Charleston J, Aboutamar HJ, Cabacungan AN, Cooper LA. Hypertension Self-management in Socially Disadvantaged African Americans: the Achieving Blood Pressure Control Together (ACT) Randomized Comparative Effectiveness Trial. J Gen Intern Med. 2020 Jan;35(1):142-152. doi: 10.1007/s11606-019-05396-7. Epub 2019 Nov 8.
- Brownstein JN, Bone LR, Dennison CR, Hill MN, Kim MT, Levine DM. Community health workers as interventionists in the prevention and control of heart disease and stroke. Am J Prev Med. 2005 Dec;29(5 Suppl 1):128-33. doi: 10.1016/j.amepre.2005.07.024.
- Viswanathan M, Kraschnewski JL, Nishikawa B, Morgan LC, Honeycutt AA, Thieda P, Lohr KN, Jonas DE. Outcomes and costs of community health worker interventions: a systematic review. Med Care. 2010 Sep;48(9):792-808. doi: 10.1097/MLR.0b013e3181e35b51.
- Jones DW, Whelton PK, Allen N, Clark D 3rd, Gidding SS, Muntner P, Nesbitt S, Mitchell NS, Townsend R, Falkner B; American Heart Association Council on Hypertension; Council on the Kidney in Cardiovascular Disease; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Lifelong Congenital Heart Disease and Heart Health in the Young; and Stroke Council. Management of Stage 1 Hypertension in Adults With a Low 10-Year Risk for Cardiovascular Disease: Filling a Guidance Gap: A Scientific Statement From the American Heart Association. Hypertension. 2021 Jun;77(6):e58-e67. doi: 10.1161/HYP.0000000000000195. Epub 2021 Apr 29.
- US Preventive Services Task Force; Barry MJ, Nicholson WK, Silverstein M, Cabana MD, Chelmow D, Coker TR, Davis EM, Donahue KE, Jaen CR, Li L, Ogedegbe G, Rao G, Ruiz JM, Stevermer J, Tsevat J, Underwood SM, Wong JB. Screening for Hypertensive Disorders of Pregnancy: US Preventive Services Task Force Final Recommendation Statement. JAMA. 2023 Sep 19;330(11):1074-1082. doi: 10.1001/jama.2023.16991.
- Devan GS, Chee KT. Munchausen syndrome: a case report. Singapore Med J. 1985 Dec;26(7):556-7. No abstract available.
- Bisson C, Patel E, Mueller A, Suresh S, Duncan C, Premkumar A, Shahul S, Rana S. Extended postpartum outcomes with systematic treatment of and management of postpartum hypertension program. Pregnancy Hypertens. 2024 Sep;37:101138. doi: 10.1016/j.preghy.2024.101138. Epub 2024 Jun 14.
- Runesha L, Yordan NT, Everett A, Mueller A, Patel E, Bisson C, Silasi M, Duncan C, Rana S. Patient perceptions of remote patient monitoring program for hypertensive disorders of pregnancy. Arch Gynecol Obstet. 2024 Sep;310(3):1563-1576. doi: 10.1007/s00404-024-07580-5. Epub 2024 Jul 8.
- Moustafa ASZ, Yimer W, Perry A, Solis L, Belk S, Morris R, Spencer SK, Rana S, Wallace K. Report from a text-based blood pressure monitoring prospective cohort trial among postpartum women with hypertensive disorders of pregnancy. BMC Pregnancy Childbirth. 2024 May 3;24(1):340. doi: 10.1186/s12884-024-06511-1.
- Oladipo V, Dada T, Suresh SC, Mueller A, Khosla K, Lopes Perdigao J, Stewart K, Duncan C, Rana S. Racial Differences in Readmissions in Hypertensive Disorders of Pregnancy. Reprod Sci. 2022 Jul;29(7):2071-2078. doi: 10.1007/s43032-022-00929-8. Epub 2022 Mar 29.
- Khosla K, Suresh S, Mueller A, Perdigao JL, Stewart K, Duncan C, Oladipo V, Fess E, Heimberger S, Rana S. Elimination of racial disparities in postpartum hypertension follow-up after incorporation of telehealth into a quality bundle. Am J Obstet Gynecol MFM. 2022 May;4(3):100580. doi: 10.1016/j.ajogmf.2022.100580. Epub 2022 Feb 1.
- Suresh SC, Duncan C, Kaur H, Mueller A, Tung A, Perdigao JL, Khosla K, Dhir R, Stewart K, Wallace K, Ahn R, Rana S. Postpartum Outcomes With Systematic Treatment and Management of Postpartum Hypertension. Obstet Gynecol. 2021 Nov 1;138(5):777-787. doi: 10.1097/AOG.0000000000004574.
- Lutenbacher M, Elkins T, Dietrich MS. Using Community Health Workers to Improve Health Outcomes in a Sample of Hispanic Women and Their Infants: Findings from a Randomized Controlled Trial. Hisp Health Care Int. 2023 Sep;21(3):129-141. doi: 10.1177/15404153221107680. Epub 2022 Jun 14.
- Pasha M, Brewer LC, Sennhauser S, Alsawas M, Murad MH. Health Care Delivery Interventions for Hypertension Management in Underserved Populations in the United States: A Systematic Review. Hypertension. 2021 Sep;78(4):955-965. doi: 10.1161/HYPERTENSIONAHA.120.15946. Epub 2021 Aug 15.
- Tsao CW, Gona PN, Salton CJ, Chuang ML, Levy D, Manning WJ, O'Donnell CJ. Left Ventricular Structure and Risk of Cardiovascular Events: A Framingham Heart Study Cardiac Magnetic Resonance Study. J Am Heart Assoc. 2015 Sep 15;4(9):e002188. doi: 10.1161/JAHA.115.002188.
- Kitt J, Krasner S, Barr L, Frost A, Tucker K, Bateman PA, Suriano K, Kenworthy Y, Lapidaire W, Lacharie M, Mills R, Roman C, Mackillop L, Cairns A, Aye C, Ferreira V, Piechnik S, Lukaschuk E, Thilaganathan B, Chappell LC, Lewandowski AJ, McManus RJ, Leeson P. Cardiac Remodeling After Hypertensive Pregnancy Following Physician-Optimized Blood Pressure Self-Management: The POP-HT Randomized Clinical Trial Imaging Substudy. Circulation. 2024 Feb 13;149(7):529-541. doi: 10.1161/CIRCULATIONAHA.123.067597. Epub 2023 Nov 11.
- Kitt J, Fox R, Frost A, Shanyinde M, Tucker K, Bateman PA, Suriano K, Kenworthy Y, McCourt A, Woodward W, Lapidaire W, Lacharie M, Santos M, Roman C, Mackillop L, Delles C, Thilaganathan B, Chappell LC, Lewandowski AJ, McManus RJ, Leeson P. Long-Term Blood Pressure Control After Hypertensive Pregnancy Following Physician-Optimized Self-Management: The POP-HT Randomized Clinical Trial. JAMA. 2023 Nov 28;330(20):1991-1999. doi: 10.1001/jama.2023.21523.
- Suresh S, Amegashie C, Patel E, Nieman KM, Rana S. Racial Disparities in Diagnosis, Management, and Outcomes in Preeclampsia. Curr Hypertens Rep. 2022 Apr;24(4):87-93. doi: 10.1007/s11906-022-01172-x. Epub 2022 Mar 7.
- Churchwell K, Elkind MSV, Benjamin RM, Carson AP, Chang EK, Lawrence W, Mills A, Odom TM, Rodriguez CJ, Rodriguez F, Sanchez E, Sharrief AZ, Sims M, Williams O; American Heart Association. Call to Action: Structural Racism as a Fundamental Driver of Health Disparities: A Presidential Advisory From the American Heart Association. Circulation. 2020 Dec 15;142(24):e454-e468. doi: 10.1161/CIR.0000000000000936. Epub 2020 Nov 10.
- Sims M, Diez-Roux AV, Gebreab SY, Brenner A, Dubbert P, Wyatt S, Bruce M, Hickson D, Payne T, Taylor H. Perceived discrimination is associated with health behaviours among African-Americans in the Jackson Heart Study. J Epidemiol Community Health. 2016 Feb;70(2):187-94. doi: 10.1136/jech-2015-206390. Epub 2015 Sep 28.
- Gunderson EP, Greenberg M, Nguyen-Huynh MN, Tierney C, Roberts JM, Go AS, Tao W, Alexeeff SE. Early Pregnancy Blood Pressure Patterns Identify Risk of Hypertensive Disorders of Pregnancy Among Racial and Ethnic Groups. Hypertension. 2022 Mar;79(3):599-613. doi: 10.1161/HYPERTENSIONAHA.121.18568. Epub 2021 Dec 29.
- Fleszar LG, Bryant AS, Johnson CO, Blacker BF, Aravkin A, Baumann M, Dwyer-Lindgren L, Kelly YO, Maass K, Zheng P, Roth GA. Trends in State-Level Maternal Mortality by Racial and Ethnic Group in the United States. JAMA. 2023 Jul 3;330(1):52-61. doi: 10.1001/jama.2023.9043.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 juli 2026
Primaire voltooiing (Geschat)
30 juni 2031
Studie voltooiing (Geschat)
30 juni 2031
Studieregistratiedata
Eerst ingediend
8 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
19 mei 2026
Eerst geplaatst (Werkelijk)
26 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
26 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
19 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Urogenitale ziekten
- Vaatziekten
- Hart-en vaatziekten
- Vrouwelijke urogenitale ziekten en zwangerschapscomplicaties
- Zwangerschap Complicaties
- Hypertensie
- Hypertensie, door zwangerschap veroorzaakt
- Health Services Administration
- Kwaliteit, toegang en evaluatie van de gezondheidszorg
- Kwaliteit van de gezondheidszorg
- Kwaliteitsindicatoren, gezondheidszorg
- Zorgstandaard
Andere studie-ID-nummers
- 0312-26-EP
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .