Hypertension (HTN)NCT07599579
Mobile Health Program for Post-Preeclampsia Hypertension
A study testing Coaching application, Home-based blood pressure monitoring and WebMD in people with Hypertension (HTN) and Preeclampsia, run by University of Pittsburgh at 1 site in United States.
Trial summary
Strategies targeted to optimize hypertension (HTN) control for midlife women after hypertensive disorders of pregnancy (HDP) have not been studied, despite evidence of a critical need. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypertension (HTN), Preeclampsia, Hypertensive Disorders of Pregnancy (HDP)
- What is being tested?
- Coaching application, Home-based blood pressure monitoring and WebMD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2026to Oct 2027
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who had a history of HDP (either gestational HTN or preeclampsia) diagnosed by ACOG guidelines at the time of delivery at Magee-Womens Hospital between 2008 and 2015, thus 10 to 20 years from their index pregnancy complicated by HDP.
- Evidence of current stage 2 HTN (BP ≥ 140/90 mmHg with or without treatment with antihypertensive medication).
Who cannot join
- Known clinical CVD (prior myocardial infarction, stroke, heart failure, or peripheral arterial disease).
- Males will also be excluded from this study as it focuses on pregnancy related conditions.
- Children will be excluded as the study is only recruiting people who are 10-20 years postpartum.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
Amy Travis, 4126413295, travisam@upmc.edu
Samantha Bryan, myslinskisg@mwri.magee.edu
About this study
Official title: Multilevel Mobile Health Program to Improve Hypertension Among Midlife Women After Hypertensive Disorder of Pregnancy
Strategies targeted to optimize hypertension (HTN) control for midlife women after hypertensive disorders of pregnancy (HDP) have not been studied, despite evidence of a critical need. This proposal targets the 10-20 years postpartum as a key time when women have subclinical cardiovascular (CV) sequelae of uncontrolled HTN and are primed for CV prevention interventions. Before proceeding with large-scale intervention trials of a home blood pressure monitoring (HBPM) and coaching intervention following HDP, further pilot testing is necessary. The overarching hypothesis of this proposal is that a new monitoring and treatment paradigm utilizing HBPM combined with a virtual coaching intervention would be better than standard of care for mid-life women with prior HDP who develop HTN. Women will be assigned in an unblinded manner to the intervention or standard of care control group.
- Being tested
- Coaching application, Home-based blood pressure monitoring, WebMD
- Keywords
- hypertension, preeclampsia, coaching, home blood pressure monitoring
- Medical subject headings
- Hypertension, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coaching applicationBehavioural
A digital application for providing education and support for home-based blood pressure monitoring.
Home-based blood pressure monitoringBehavioural
Device for measuring blood pressure at home with blue tooth connectivity for automated collection.
WebMDOther
Smartphone-based application for health education and/or monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Coaching Application + HBPM | Experimental | A smartphone-based, interactive coaching application designed to enhance adherence to home-based blood pressure monitoring and provide guidance on blood pressure management, patient-facing education, and assistance with modifying behaviors associated with poor blood pressure control. The application is connected to a wireless blood pressure cuff for accurate blood pressure measurement and automated storage on a digital platform. All participants in the experimental arm receive a smartphone for the 3-month intervention duration and a Bluetooth blood pressure cuff. Receives: Behavioral: Coaching application; Behavioral: Home-based blood pressure monitoring |
| Enhanced usual care with WebMD | Active comparator | Enhanced usual care participants will receive a smartphone for the 3-month intervention duration and the wireless Bluetooth blood pressure cuff. Through this, enhanced usual care participants will have access to WebMD, a smartphone-based tool for learning about blood pressure and other health conditions. Enhanced usual care participants will also receive a wireless blood pressure cuff for accurate blood pressure measurement and automated storage on a digital platform. Receives: Behavioral: Home-based blood pressure monitoring; Other: WebMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure from baseline to 3 months
Change in home-based systolic blood pressure from baseline to 3 months between the intervention and usual care arms.
Measured: Baseline, 3 Months
Secondary outcomes (9)
Change in diastolic BP and mean arterial pressure from baseline to 3 months
Change in diastolic BP and mean arterial pressure from baseline to 3 months
Measured: Baseline, 3 months
Adherence to antihypertensive medications at 3 months and 6 months
Adherence to antihypertensive medication from baseline to 6 months between the intervention and usual care arms using Proportion of Days Covered, ranging from 0 to 100%, where higher values indicate superior medication adherence.
Measured: Baseline, 6 months
Proportion with BP controlled <130/80 mmHg at 3 months and 6 months
Measured: Baseline, 3 months, 6 months
Adherence to home blood pressure monitoring
Quantification of home blood pressure monitoring during the 3-month intervention phase, ranging from 0 to 100%, where higher values indicate superior adherence.
Measured: Baseline, 3 months
Feasibility of study measured using enrollment, survey completion, and retention of participants
Proportions of participants who complete all study visits and surveys out of all participants enrolled in the study
Measured: Baseline, 3 Month, 6 Month
Durable change in systolic blood pressure measures at 6 months
Durable change in SBP measures at 6 months between intervention and usual care arms
Measured: Baseline, 6 months
Durable change in diastolic BP measures at 6 months
Durable change in DBP measures at 6 months between intervention and usual care arms
Measured: Baseline, 6 months
Blood pressure at 3 months
Systolic, diastolic, and mean arterial blood pressure at 3 months
Measured: Baseline, 3 months
Blood pressure at 6 months
Systolic, diastolic, and mean arterial blood pressure at 6 months
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start22 Jul 2026
- Primary completionJul 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension (HTN)Studies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to the intervention or usual care by the study team, and they will be informed at the time of consent what group they will participate in
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- McKamish Family Foundation
- Responsible party
- Principal investigator, Malamo Countouris, University of Pittsburgh
- Investigators
- Malamo Countouris, MD, MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599579
- Sponsor's protocol ID
- STUDY25070197
- Status last verified
- Jul 2026
- First submitted
- 14 May 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study team will share all of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multilevel Mobile Health Program to Improve Hypertension Among Midlife Women After Hypertensive Disorder of Pregnancy
- ClinicalTrials.gov ID
- NCT07599579
- Acronym / sponsor ID
- STUDY25070197
- Keywords
- hypertension, preeclampsia, coaching, home blood pressure monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- McKamish Family Foundation
- Study start
- 22 Jul 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 20 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.
Strategies targeted to optimize hypertension (HTN) control for midlife women after hypertensive disorders of pregnancy (HDP) have not been studied, despite evidence of a critical need. This proposal targets the 10-20 years postpartum as a key time when women have subclinical cardiovascular (CV) sequelae of uncontrolled HTN and are primed for CV prevention interventions. Before proceeding with large-scale intervention trials of a home blood pressure monitoring (HBPM) and coaching intervention following HDP, further pilot testing is necessary. The overarching hypothesis of this proposal is that a new monitoring and treatment paradigm utilizing HBPM combined with a virtual coaching intervention would be better than standard of care for mid-life women with prior HDP who develop HTN. Women will be assigned in an unblinded manner to the intervention or standard of care control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to the intervention or usual care by the study team, and they will be informed at the time of consent what group they will participate in
| Arm | Type | Receives |
|---|---|---|
| Coaching Application + HBPM | Experimental | Behavioral: Coaching application, Behavioral: Home-based blood pressure monitoringA smartphone-based, interactive coaching application designed to enhance adherence to home-based blood pressure monitoring and provide guidance on blood pressure management, patient-facing education, and assistance with modifying behaviors associated with poor blood pressure control. The application is connected to a wireless blood pressure cuff for accurate blood pressure measurement and automated storage on a digital platform. All participants in the experimental arm receive a smartphone for the 3-month intervention duration and a Bluetooth blood pressure cuff. |
| Enhanced usual care with WebMD | Active comparator | Behavioral: Home-based blood pressure monitoring, Other: WebMDEnhanced usual care participants will receive a smartphone for the 3-month intervention duration and the wireless Bluetooth blood pressure cuff. Through this, enhanced usual care participants will have access to WebMD, a smartphone-based tool for learning about blood pressure and other health conditions. Enhanced usual care participants will also receive a wireless blood pressure cuff for accurate blood pressure measurement and automated storage on a digital platform. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women who had a history of HDP (either gestational HTN or preeclampsia) diagnosed by ACOG guidelines at the time of delivery at Magee-Womens Hospital between 2008 and 2015, thus 10 to 20 years from their index pregnancy complicated by HDP.
- Evidence of current stage 2 HTN (BP ≥ 140/90 mmHg with or without treatment with antihypertensive medication).
Key exclusion criteria (3 listed)
- Known clinical CVD (prior myocardial infarction, stroke, heart failure, or peripheral arterial disease).
- Males will also be excluded from this study as it focuses on pregnancy related conditions.
- Children will be excluded as the study is only recruiting people who are 10-20 years postpartum.
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 |
|---|---|---|
| Coaching applicationA digital application for providing education and support for home-based blood pressure monitoring. | Behavioural | Coaching Application + HBPM |
| Home-based blood pressure monitoringDevice for measuring blood pressure at home with blue tooth connectivity for automated collection. | Behavioural | Coaching Application + HBPM, Enhanced usual care with WebMD |
| WebMDSmartphone-based application for health education and/or monitoring. | Other | Enhanced usual care with WebMD |
Primary outcome
Change in systolic blood pressure from baseline to 3 months
Time frame: Baseline, 3 Months
Change in home-based systolic blood pressure from baseline to 3 months between the intervention and usual care arms.
9 secondary outcomes
Change in diastolic BP and mean arterial pressure from baseline to 3 months
Time frame: Baseline, 3 months
Adherence to antihypertensive medications at 3 months and 6 months
Time frame: Baseline, 6 months
Proportion with BP controlled <130/80 mmHg at 3 months and 6 months
Time frame: Baseline, 3 months, 6 months
Adherence to home blood pressure monitoring
Time frame: Baseline, 3 months
Feasibility of study measured using enrollment, survey completion, and retention of participants
Time frame: Baseline, 3 Month, 6 Month
Durable change in systolic blood pressure measures at 6 months
Time frame: Baseline, 6 months
Durable change in diastolic BP measures at 6 months
Time frame: Baseline, 6 months
Blood pressure at 3 months
Time frame: Baseline, 3 months
Blood pressure at 6 months
Time frame: Baseline, 6 months
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 Jul 2026.
- Individual participant dataSharing planned: Yes. The study team will share all of the individual participant data collected during the trial, after deidentification.
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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.
Malamo Countouris, MD, MS principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coaching application, Home-based blood pressure monitoring and WebMD in people with Hypertension (HTN) and Preeclampsia, run by University of Pittsburgh at 1 site 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 2 inclusion and 3 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 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Amy Travis (4126413295, travisam@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic blood pressure from baseline to 3 months (time frame: Baseline, 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2026.