Hypertension in PregnancyRI-SPHERESNCT06842875
Rhode Island - Statewide Postpartum Hypertension Remote Surveillance
A study testing RI-SPHERES and Standard self-measured blood pressure program in people with Hypertension in Pregnancy and Postpartum Preeclampsia, run by Women and Infants Hospital of Rhode Island at 5 sites in United States.
Trial summary
This is a hybrid type 1 non-inferiority implementation effectiveness trial among postpartum patients with hypertension (N=1536) that will test the hypothesis that RI-SPHERES (a technologically enabled collaborative care model) is non-inferior to a standard self-measured blood pressure program in terms of persistent… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Hypertension in Pregnancy, Postpartum Preeclampsia, Postpartum Complication
- What is being tested?
- RI-SPHERES and Standard self-measured blood pressure program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,536 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Apr 2025to 1 Mar 2029
- 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Postpartum patient aged 18 years or more at any birthing hospital in Rhode Island
- Diagnosed during pregnancy or after delivery with hypertensive disorder of pregnant
- English-, Spanish-, Portuguese-, or Haitian-Creole-speaking
- Smartphone ownership
Who cannot join
- Prior enrollment in this trial
- Prisoners or incarcerated people
- Inability or unwillingness to provide informed consent
- Inability to communicate with study team, despite an interpreter
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Not yet recruiting
Newport Hospital
Newport, Rhode Island, 02840
Emily Blosser, MD, PhD, 401-846-6400, eblosser@lifespan.org
- Recruiting
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02903
Stephanie Nunez, BS, 401-274-1122, snunez@wihri.org
Adam Lewkowitz, MD, MPHS
- Not yet recruiting
South County Hospital
Wakefield, Rhode Island, 02879
Megin Dalton, MD, 401-782-8000, mdalton@southcountyhealth.org
- Recruiting
Kent Hospital
Warwick, Rhode Island, 02886
Jen Buckley, MD, 401-227-3669, JBuckley@carene.org
Caroline Richardson, MD
- Recruiting
Landmark Hospital
Woonsocket, Rhode Island, 02895
Sue Magee, MD, 401-769-4100, susannamagee@gmail.com
About this study
Official title: Effect of a Technology-based Collaborative Model on Persistent Hypertension and Preventive Care Attendance Among Postpartum People With Hypertensive Disorders of Pregnancy
This is a hybrid type 1 non-inferiority implementation effectiveness trial among postpartum patients with hypertension (N=1536) that will test the hypothesis that RI-SPHERES (a technologically enabled collaborative care model) is non-inferior to a standard self-measured blood pressure program in terms of persistent hypertension at six weeks postpartum and preventive care receipt within one year of delivery.
Read the detailed description
Uncontrolled hypertensive disorders of pregnancy (HDP) are a major source of maternal mortality. National guidelines recommend blood pressure (BP) measurement 3-10 days after discharge and ≥1 preventive care visit within one year of delivery. Yet, barriers such as childcare or transportation issues reduce adherence to in-person BP checks, particularly among racial or ethnic minority patients. Programs in which patients self-measure BP (SMBP) at home show promising results regardless of patient race. However, a recent meta-analysis concluded current SMBP programs do not reduce maternal mortality or racial disparities in clinical outcomes, potentially due to their specific limitations: they end within six weeks of birth (though HDP can persist for months) and have decreased engagement with non-White people or those living in disadvantaged areas, though these populations are at the highest risk of persistent HTN and its adverse long-term effects. Thus, there is an urgent need to optimize SMBP programs to target short- and long-term HDP-related morbidity and to broadly implement these programs to eliminate disparities in HDP-related outcomes. One such program is Rhode Island (RI)-Statewide Postpartum HypErtension REmote Surveillance (RI-SPHERES), a technology-based SMBP program that aims to reduce short- and long-term HDP-associated morbidity in RI using the collaborative care model, a health services intervention that improves health outcomes and reduces racial disparities on a population level for people with chronic conditions. The proposed research aims to determine the effectiveness of RI-SPHERES in reducing short- and long-term morbidity associated with HDP throughout RI. This builds upon our pilot RCT (NCT05595629), in which a standard SMBP program was compared to a SMBP program that used a Bluetooth-enabled BP cuff that syncs to a smartphone application (app) to send automated reminders and provide adaptive messaging tailored to distinct BP values and symptoms. RI-SPHERES will expand this SMBP program to provide app-based patient-informed educational content on HDP-specific preventive care and bidirectional communication with RI-SPHERES staff for one year postpartum. Incorporating adaptive and automatic messaging increases RI-SPHERES' scalability by reducing clinical staff burden. However, formal analysis of factors that may hinder widespread implementation of RI-SPHERES is needed. Thus, we will conduct a Hybrid Type I Non-Inferiority Implementation-Effectiveness Trial among 1536 patients with HDP that compares a standard SMBP program to RI-SPHERES in terms of persistent HTN at six weeks postpartum and receipt of preventive care within one year of delivery (Specific Aim 1). We will examine the effect of both programs on increasing equity in terms of race, ethnicity, language, and geography for postpartum patients with HDP in Rhode Island (Specific Aim 2). We will also develop an implementation toolkit to facilitate the dissemination of RI-SPHERES (Specific Aim 3). The proposed project is expected to deliver a mechanism that will fill multiple research gaps for HDP identified by the US Preventive Services Task Force: 1) addressing health inequities through multilevel interventions, 2) evaluating SMBP programs; and 3) mitigating HDP's short- and long-term health consequences of HDP.
- Being tested
- RI-SPHERES, Standard self-measured blood pressure program
- Keywords
- postpartum hypertensive disorders of pregnancy, postpartum preeclampsia, digital health, collaborative care model, population health, self-measured blood pressure
- 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.
RI-SPHERESBehavioural
Participants assigned to the RI-SPHERES group will be introduced virtually or in-person to the care manager (CM), who demonstrate how to communicate directly with patients through the app for medical or non-medical needs. Each participant will learn how to obtain SMBP, sync the LTE-enabled BP cuff to the RI-SPHERES app, and respond to adaptive messaging pertaining to BP measurements, which include the ability to receive on-demand education on postpartum topics (e.g., HDP, breastfeeding, mood disorders) per participant preference. During the study period, the CM will respond to needs elicited from the SDoH screening by facilitating referrals to community resources. After six weeks, the focus of RI-SPHERES will transition to preventive care in addition to SMBP. The CM will engage monthly with each study participant to ensure they have a primary care provider and to facilitate preventive care visits or specialist appointments, if needed.
Standard self-measured blood pressure programBehavioural
Participants assigned to the routine care group meet virtually or in-person with a member of WIH's existing SMBP program and enroll in WIH's EPIC MyChart Portal to allow the SMBP program to receive patient-entered BP measurements and respond to messages. Participants will be provided with BP cuffs and taught how to obtain SMBP and report their BP through MyChart. At six weeks postpartum, WIH SMBP staff send a MyChart message to recommend BP ascertainment once per month and to describe the importance of attending a clinical visit with a primary care provider within a year of birth.
| Study group | Role | What they receive |
|---|---|---|
| RI-SPHERES | Experimental | A technology enabled collaborative care model. Participants will receive a LTE-enabled blood pressure (BP) cuff that syncs to a smartphone application (app) to send automated reminders and provide adaptive messaging tailored to distinct BP values and symptoms. The first six weeks of the program will focus on BP control, and the remaining time will help transition people to receive recommended preventive care. As part of the collaborative care model, the nurse practitioner will lead weekly meetings with a multidisciplinary clinical team about all enrolled people. Receives: Behavioral: RI-SPHERES |
| Standard self-measured blood pressure program | Active comparator | Our hospital has a remote hypertension monitoring program that recommends daily blood pressure ascertainment for 6 weeks, at which time they are discharged and provided printed resources to encourage preventive care in the next few months. In this program, patients manually enter their self-measured BPs into the electronic medical record for the clinical team to manually review and respond. Receives: Behavioral: Standard self-measured blood pressure program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent hypertension
Persistent stage II hypertension will be defined as systolic blood pressure of 140 mmHg or higher and/or diastolic blood pressure of 90 mmHg or higher
Measured: Six weeks postpartum
Secondary outcomes (14)
Attendance of preventive care visit
Participant attends a non-urgent appointment during which an internal medicine physician, family medicine physician, or primary care advanced practice provider (APP, including nurse practitioners or physician assistants) ascertains BP and provides patient counseling pertaining to HTN. While obstetrician-gynecologists (OBGYNs) or certified nurse midwives (CNMs) can provide preventive care, for this aim, visits provided by an OBGYN or CNM will only qualify if the visit occurs ≥6 weeks postpartum and the medical record states that HTN was discussed in the visit.
Measured: From six weeks postpartum until one year postpartum
Blood pressure ascertainment
Participant measured any BP (either in-person or via self-measured blood pressure)
Measured: 1-10 days after hospital discharge
Total number of self-measured blood pressure assessments provided to program in immediate postpartum period
Number of blood pressures sent in to the participant's self-measured blood pressure program (RI-SPHERES or standard program)
Measured: Hospital discharge to six weeks postpartum
Total number of self-measured blood pressure assessments provided to program after six weeks postpartum
Number of blood pressures sent in to the participant's self-measured blood pressure program (RI-SPHERES or standard program)
Measured: Six weeks postpartum until one year postpartum
Severe maternal morbidity after hospital discharge
Severe maternal morbidity, as defined by the Centers for Disease Control's composite.
Measured: Hospital discharge until 6 weeks postpartum
Persistent stage I hypertension
Systolic blood pressure between 130-139 mmHg and/or diastolic blood pressure between 80-89 mmHg
Measured: Six weeks, six months, and 12 months postpartum
Persistent stage II hypertension
Systolic blood pressure at or above 140 mmHg and/or diastolic blood pressure at or above 90 mmHg
Measured: Six and 12 months postpartum
Severe hypertension after hospital discharge
Systolic blood pressure at or above 160 mmHg or diastolic blood pressure at or above 110 mmHg on two or more occasions
Measured: Hospital discharge to 6 weeks postpartum
Emergency room visit for hypertension-related etiology
Presentation to emergency room for hypertension-related chief complaint
Measured: Hospital discharge to 6 weeks postpartum
Readmission to inpatient hospital for hypertension-related etiology
Readmission to inpatient hospital for hypertension-related chief complaint
Measured: Hospital discharge until 6 weeks postpartum
Initiation or titration of antihypertension medication
Initiation or increase in dose titration of antihypertensive medication(s)
Measured: Hospital discharge to 6 weeks postpartum
Postpartum visit attendance
Attendance to the recommended in-person postpartum visit
Measured: Four to six weeks postpartum
System usability scale
A 10-question survey designed to provide a global view of subjective assessments of usability for a technology-based program or intervention
Measured: Six weeks, six months, and 12 months postpartum
Client satisfaction questionnaire
A survey designed to provide an overview of individual satisfaction with a program or intervention
Measured: Six weeks, six months, and 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start15 Apr 2025
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension in PregnancyStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,536 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University, Kent Hospital, Rhode Island
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842875
- Sponsor's protocol ID
- 2184383
- Acronym
- RI-SPHERES
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be collected from human subjects and will be shared according to NIH guidelines. The investigators are committed to the sharing of final data, being mindful that the rights and privacy of people who participate in research must be protected at all times. The investigators will make a complete study dataset available for sharing. The investigators will have a description of study dataset, including code books, meta-data related to the dataset, and documented programming code used for creating the final study population, for creating variables, and for conducting all outcomes analyses. The investigators will remain HIPAA compliant, and therefore any datasets resulting from participants will be free of any identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of individual subjects.
Publications
Nunez SD, Spratt LM, Ware CF, Machado S, Rousseau J, Jackson TL, Buckley J, Magee S, Wohler D, Blosser E, Sales S, Simmons D, Ramos VN, Castillo MM, Murray C, Bailey K, Gutman R, Richardson CR, Grobman WA, Hauspurg A, Miller ES, Tuuli MG, Lewkowitz AK. Protocol for a type 1 hybrid effectiveness implementation trial to evaluate whether a technology-based collaborative care model is non-inferior to remote blood pressure monitoring on persistent hypertension and preventive care attendance among postpartum people with hypertension. Contemp Clin Trials. 2025 Dec;159:108114. doi: 10.1016/j.cct.2025.108114. Epub 2025 Oct 23.
PubMed 41139061
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Technology-based Collaborative Model on Persistent Hypertension and Preventive Care Attendance Among Postpartum People With Hypertensive Disorders of Pregnancy
- ClinicalTrials.gov ID
- NCT06842875
- Acronym / sponsor ID
- RI-SPHERES / 2184383
- Keywords
- postpartum hypertensive disorders of pregnancy, postpartum preeclampsia, digital health, collaborative care model, population health, self-measured blood pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,536 participants (estimated)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Collaborators
- Brown University, Kent Hospital, Rhode Island
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 24 Feb 2025 (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.
This is a hybrid type 1 non-inferiority implementation effectiveness trial among postpartum patients with hypertension (N=1536) that will test the hypothesis that RI-SPHERES (a technologically enabled collaborative care model) is non-inferior to a standard self-measured blood pressure program in terms of persistent hypertension at six weeks postpartum and preventive care receipt within one year of delivery.
Detailed description
Uncontrolled hypertensive disorders of pregnancy (HDP) are a major source of maternal mortality. National guidelines recommend blood pressure (BP) measurement 3-10 days after discharge and ≥1 preventive care visit within one year of delivery. Yet, barriers such as childcare or transportation issues reduce adherence to in-person BP checks, particularly among racial or ethnic minority patients. Programs in which patients self-measure BP (SMBP) at home show promising results regardless of patient race. However, a recent meta-analysis concluded current SMBP programs do not reduce maternal mortality or racial disparities in clinical outcomes, potentially due to their specific limitations: they end within six weeks of birth (though HDP can persist for months) and have decreased engagement with non-White people or those living in disadvantaged areas, though these populations are at the highest risk of persistent HTN and its adverse long-term effects. Thus, there is an urgent need to optimize SMBP programs to target short- and long-term HDP-related morbidity and to broadly implement these programs to eliminate disparities in HDP-related outcomes. One such program is Rhode Island (RI)-Statewide Postpartum HypErtension REmote Surveillance (RI-SPHERES), a technology-based SMBP program that aims to reduce short- and long-term HDP-associated morbidity in RI using the collaborative care model, a health services intervention that improves health outcomes and reduces racial disparities on a population level for people with chronic conditions. The proposed research aims to determine the effectiveness of RI-SPHERES in reducing short- and long-term morbidity associated with HDP throughout RI. This builds upon our pilot RCT (NCT05595629), in which a standard SMBP program was compared to a SMBP program that used a Bluetooth-enabled BP cuff that syncs to a smartphone application (app) to send automated reminders and provide adaptive messaging tailored to distinct BP values and symptoms. RI-SPHERES will expand this SMBP program to provide app-based patient-informed educational content on HDP-specific preventive care and bidirectional communication with RI-SPHERES staff for one year postpartum. Incorporating adaptive and automatic messaging increases RI-SPHERES' scalability by reducing clinical staff burden. However, formal analysis of factors that may hinder widespread implementation of RI-SPHERES is needed. Thus, we will conduct a Hybrid Type I Non-Inferiority Implementation-Effectiveness Trial among 1536 patients with HDP that compares a standard SMBP program to RI-SPHERES in terms of persistent HTN at six weeks postpartum and receipt of preventive care within one year of delivery (Specific Aim 1). We will examine the effect of both programs on increasing equity in terms of race, ethnicity, language, and geography for postpartum patients with HDP in Rhode Island (Specific Aim 2). We will also develop an implementation toolkit to facilitate the dissemination of RI-SPHERES (Specific Aim 3). The proposed project is expected to deliver a mechanism that will fill multiple research gaps for HDP identified by the US Preventive Services Task Force: 1) addressing health inequities through multilevel interventions, 2) evaluating SMBP programs; and 3) mitigating HDP's short- and long-term health consequences of HDP.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RI-SPHERES | Experimental | Behavioral: RI-SPHERESA technology enabled collaborative care model. Participants will receive a LTE-enabled blood pressure (BP) cuff that syncs to a smartphone application (app) to send automated reminders and provide adaptive messaging tailored to distinct BP values and symptoms. The first six weeks of the program will focus on BP control, and the remaining time will help transition people to receive recommended preventive care. As part of the collaborative care model, the nurse practitioner will lead weekly meetings with a multidisciplinary clinical team about all enrolled people. |
| Standard self-measured blood pressure program | Active comparator | Behavioral: Standard self-measured blood pressure programOur hospital has a remote hypertension monitoring program that recommends daily blood pressure ascertainment for 6 weeks, at which time they are discharged and provided printed resources to encourage preventive care in the next few months. In this program, patients manually enter their self-measured BPs into the electronic medical record for the clinical team to manually review and respond. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Postpartum patient aged 18 years or more at any birthing hospital in Rhode Island
- Diagnosed during pregnancy or after delivery with hypertensive disorder of pregnant
- English-, Spanish-, Portuguese-, or Haitian-Creole-speaking
- Smartphone ownership
Key exclusion criteria (4 listed)
- Prior enrollment in this trial
- Prisoners or incarcerated people
- Inability or unwillingness to provide informed consent
- Inability to communicate with study team, despite an interpreter
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 |
|---|---|---|
| RI-SPHERESParticipants assigned to the RI-SPHERES group will be introduced virtually or in-person to the care manager (CM), who demonstrate how to communicate directly with patients through the app for medical or non-medical needs. Each participant will learn how to obtain SMBP, sync the LTE-enabled BP cuff to the RI-SPHERES app, and respond to adaptive messaging pertaining to BP measurements, which include the ability to receive on-demand education on postpartum topics (e.g., HDP, breastfeeding, mood disorders) per participant preference. During the study period, the CM will respond to needs elicited from the SDoH screening by facilitating referrals to community resources. After six weeks, the focus of RI-SPHERES will transition to preventive care in addition to SMBP. The CM will engage monthly with each study participant to ensure they have a primary care provider and to facilitate preventive care visits or specialist appointments, if needed. | Behavioural | RI-SPHERES |
| Standard self-measured blood pressure programParticipants assigned to the routine care group meet virtually or in-person with a member of WIH's existing SMBP program and enroll in WIH's EPIC MyChart Portal to allow the SMBP program to receive patient-entered BP measurements and respond to messages. Participants will be provided with BP cuffs and taught how to obtain SMBP and report their BP through MyChart. At six weeks postpartum, WIH SMBP staff send a MyChart message to recommend BP ascertainment once per month and to describe the importance of attending a clinical visit with a primary care provider within a year of birth. | Behavioural | Standard self-measured blood pressure program |
Primary outcome
Persistent hypertension
Time frame: Six weeks postpartum
Persistent stage II hypertension will be defined as systolic blood pressure of 140 mmHg or higher and/or diastolic blood pressure of 90 mmHg or higher
14 secondary outcomes
Attendance of preventive care visit
Time frame: From six weeks postpartum until one year postpartum
Blood pressure ascertainment
Time frame: 1-10 days after hospital discharge
Total number of self-measured blood pressure assessments provided to program in immediate postpartum period
Time frame: Hospital discharge to six weeks postpartum
Total number of self-measured blood pressure assessments provided to program after six weeks postpartum
Time frame: Six weeks postpartum until one year postpartum
Severe maternal morbidity after hospital discharge
Time frame: Hospital discharge until 6 weeks postpartum
Persistent stage I hypertension
Time frame: Six weeks, six months, and 12 months postpartum
Persistent stage II hypertension
Time frame: Six and 12 months postpartum
Severe hypertension after hospital discharge
Time frame: Hospital discharge to 6 weeks postpartum
Emergency room visit for hypertension-related etiology
Time frame: Hospital discharge to 6 weeks postpartum
Readmission to inpatient hospital for hypertension-related etiology
Time frame: Hospital discharge until 6 weeks postpartum
Initiation or titration of antihypertension medication
Time frame: Hospital discharge to 6 weeks postpartum
Postpartum visit attendance
Time frame: Four to six weeks postpartum
System usability scale
Time frame: Six weeks, six months, and 12 months postpartum
Client satisfaction questionnaire
Time frame: Six weeks, six months, and 12 months 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 17 Jun 2025.
- Derived from this study: PubMed 41139061Nunez SD, Spratt LM, Ware CF, Machado S, Rousseau J, Jackson TL, Buckley J, Magee S, Wohler D, Blosser E, Sales S, Simmons D, Ramos VN, Castillo MM, Murray C, Bailey K, Gutman R, Richardson CR, Grobman WA, Hauspurg A, Miller ES, Tuuli MG, Lewkowitz AK. Protocol for a type 1 hybrid effectiveness implementation trial to evaluate whether a technology-based collaborative care model is non-inferior to remote blood pressure monitoring on persistent hypertension and preventive care attendance among postpartum people with hypertension. Contemp Clin Trials. 2025 Dec;159:108114. doi: 10.1016/j.cct.2025.108114. Epub 2025 Oct 23.
- Individual participant dataSharing planned: Yes. Data will be collected from human subjects and will be shared according to NIH guidelines. The investigators are committed to the sharing of final data, being mindful that the rights and privacy of people who participate in research must be protected at all times. The investigators will make a complete study dataset available for sharing. The investigators will have a description of study dataset, including code books, meta-data related to the dataset, and documented programming code used for creating the final study population, for creating variables, and for conducting all outcomes analyses. The investigators will remain HIPAA compliant, and therefore any datasets resulting from participants will be free of any identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of individual subjects.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RI-SPHERES and Standard self-measured blood pressure program in people with Hypertension in Pregnancy and Postpartum Preeclampsia, run by Women and Infants Hospital of Rhode Island at 5 sites in United States.
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 4 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: looking for participants now, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Stephanie Nunez, Research Coordinator (401-274-1122, snunez@wihri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent hypertension (time frame: Six weeks 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 NCT06842875, which also lists 1 linked publication.
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 17 Jun 2025.