Hypertensive Disorders of Pregnancy (HDP)PRIME CARENCT07606027
Community Support and Mobile Apps to Help Black Women Control High Blood Pressure After Pregnancy
A study testing Collaborative care in people with Hypertensive Disorders of Pregnancy (HDP) and Hypertension, Pregnancy Induced, run by University of Nebraska.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 to 50 years, women only
- Conditions the study is for
- Hypertensive Disorders of Pregnancy (HDP), Hypertension, Pregnancy Induced, Severe Maternal Morbidity
- What is being tested?
- Collaborative care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Age: <19 years
- Significant Kidney or Liver disease that may limit antihypertensive medication adjustment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Hypertensive Disorders of Pregnancy (HDP), Hypertension, Pregnancy Induced, Severe Maternal Morbidity, Postpartum Hypertension
- Being tested
- Collaborative care, Standard of Care (SOC)
- Keywords
- Hypertension, Pregnancy-Induced, Postpartum Period, Remote Blood Pressure Monitoring, Community Health Workers, Postpartum Care, African American Women
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative careOther
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.
Standard of Care (SOC)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Collaborative Care Intervention | Experimental | 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. Receives: Other: Collaborative care |
| Standard Postpartum Care | Active comparator | 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. Receives: Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Control (BP <130/80 mmHg)
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).
Measured: Baseline (6 weeks) postpartum to 12 months postpartum
Secondary outcomes (3)
Patient Activation Measure (PAM-13)
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).
Measured: At Baseline (6 weeks) postpartum, 6 months postpartum and 12 months (1 year) postpartum
Trust in Physician Scale
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).
Measured: At Baseline (6 weeks) postpartum, 6 months postpartum, and 12 months (1 year) postpartum.
Severe Maternal Morbidity (SMM) Composite Rate
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.
Measured: Baseline (6weeks) postpartum to 12 months (1 year) postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Jun 2031 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for Hypertensive Disorders of Pregnancy (HDP)Studies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a parallel assignment design to either the collaborative care intervention or standard postpartum care at approximately 6 weeks postpartum. The collaborative care intervention includes remote blood pressure monitoring using a home device and support from community health workers who provide education, care coordination, and assistance with healthcare navigation. The standard care group will receive usual postpartum care along with home blood pressure monitoring. Participants will be followed for 12 months postpartum to assess blood pressure control, clinical outcomes, and patient-reported measures
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 404 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sajid Shahul, MD, PhD, Principal investigator, Department of Anesthesia, University of Nebraska Medical Center, Omaha, NE, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606027
- Sponsor's protocol ID
- 0312-26-EP
- Acronym
- PRIME CARE
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 2084735Health 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.
PubMed 7261636Shahul 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.
PubMed 29111424Shahul 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.
PubMed 29844146Shahul 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.
PubMed 27113052Royston 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.
PubMed 21611958Karrison 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.
PubMed 9129859Fritz 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.
PubMed 17444920
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Remote Monitoring and Integration of Mobile Health With Engagement From Community Health Workers for Regulating Elevated Blood Pressure
- ClinicalTrials.gov ID
- NCT07606027
- Acronym / sponsor ID
- PRIME CARE / 0312-26-EP
- Conditions
- Hypertensive Disorders of Pregnancy (HDP), Hypertension, Pregnancy Induced, Severe Maternal Morbidity, Postpartum Hypertension
- Keywords
- Hypertension, Pregnancy-Induced, Postpartum Period, Remote Blood Pressure Monitoring, Community Health Workers, Postpartum Care, African American Women
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 404 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a parallel assignment design to either the collaborative care intervention or standard postpartum care at approximately 6 weeks postpartum. The collaborative care intervention includes remote blood pressure monitoring using a home device and support from community health workers who provide education, care coordination, and assistance with healthcare navigation. The standard care group will receive usual postpartum care along with home blood pressure monitoring. Participants will be followed for 12 months postpartum to assess blood pressure control, clinical outcomes, and patient-reported measures
| Arm | Type | Receives |
|---|---|---|
| Collaborative Care Intervention | Experimental | Other: Collaborative careParticipants 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. |
| Standard Postpartum Care | Active comparator | Other: Standard of Care (SOC)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. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Age: <19 years
- Significant Kidney or Liver disease that may limit antihypertensive medication adjustment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative careBluetooth-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. | Other | Collaborative Care Intervention |
| Standard of Care (SOC)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. | Other | Standard Postpartum Care |
Primary outcome
Blood Pressure Control (BP <130/80 mmHg)
Time frame: 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).
3 secondary outcomes
Patient Activation Measure (PAM-13)
Time frame: At Baseline (6 weeks) postpartum, 6 months postpartum and 12 months (1 year) postpartum
Trust in Physician Scale
Time frame: At Baseline (6 weeks) postpartum, 6 months postpartum, and 12 months (1 year) postpartum.
Severe Maternal Morbidity (SMM) Composite Rate
Time frame: Baseline (6weeks) postpartum to 12 months (1 year) postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 2084735Anderson 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.
- BackgroundHealth 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.
- BackgroundAHA. Postpartum Systems of Care Recommendations. https://wwwheartorg/-/media/files /professional/quality-improvement/maternal-health/recommendationsformatted. 2024.
- BackgroundAssistant Secretary for Public Affairs (ASPA) DoHaHSH. Strengthening Maternal Health. Available from: https://www.hhs.gov/healthcare/maternal-health/index.html.
- BackgroundRoderick J. A. Little DBR. Statistical Analysis with Missing Data 2002.
- BackgroundPatricia M. Grambsch TMT. Proportional Hazards Tests and Diagnostics Based on Weighted Residuals. Biometrika, Vol 81, No 3 (Aug, 1994), pp 515-526 (12 pages).
- BackgroundKaplan EL, & Meier, P. . Nonparametric Estimation from Incomplete Observations. Journal of the American Statistical Association. 1958.
- BackgroundCox DR. Regression Models and Life-Tables Journal of the Royal Statistical Society: Series B (Methodological), Volume 34, Issue 2.
- Background: PubMed 7261636Karrison T. Data editing in a clinical trial. Control Clin Trials. 1981 May;2(1):15-29. doi: 10.1016/0197-2456(81)90055-6.
- Background: PubMed 29111424Shahul 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.
- Background: PubMed 29844146Shahul 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.
- Background: PubMed 27113052Shahul 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sajid Shahul, MD, PhD principal investigator
Department of Anesthesia, University of Nebraska Medical Center, Omaha, NE, USA
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative care in people with Hypertensive Disorders of Pregnancy (HDP) and Hypertension, Pregnancy Induced, run by University of Nebraska.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sajid Shahul, MD, PhD (773-398-2956, sshahul@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure Control (BP <130/80 mmHg) (time frame: Baseline (6 weeks) postpartum to 12 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07606027, which also lists 52 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.