HypertensionNCT06331754
Technology-Enabled Remote Hypertension Management To Advance Health Equity
A study testing Technology-enabled blood pressure management in people with Hypertension, run by Atman Health, Inc.
Trial summary
The primary objective of this study is to reliably estimate the difference in blood pressure control of a technology-enabled solution for blood pressure (BP) management over usual care. The study will also assess patient and provider satisfaction with the solution. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Technology-enabled blood pressure management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 18 Mar 2024to 17 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years - 100 years
- uncontrolled hypertension: as defined as SBP > 140 or DBP > 90 on 2 successive clinic visits
Who cannot join
- hearing impaired
- visually impaired
- cognitively impaired
- hospice care
- on hemodialysis at enrollment
- New York Heart Association Class IV heart failure
Trial locations and contacts
No sites are listed yet.
About this study
The primary objective of this study is to reliably estimate the difference in blood pressure control of a technology-enabled solution for blood pressure (BP) management over usual care. The study will also assess patient and provider satisfaction with the solution. Finally, the investigators will estimate the economic impact of the intervention in terms of resource utilization.
Read the detailed description
The study design is a non-blinded pragmatic cluster-randomized controlled trial with a single intervention. Participants with uncontrolled hypertension will be identified from a randomly selected group of primary care clinics. Participants from half of the clinics will be enrolled in the intervention arm while the others will receive usual care. Participants in the intervention arm will undergo a series of software-driven medication initiation and titration steps until they reach a blood pressure target of systolic blood pressure < 130 mmHg and diastolic blood pressure < 80 mmHg. Participants will be subsequently monitored for up to 12 more months.
- Conditions
- Hypertension
- Being tested
- Technology-enabled blood pressure management
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-enabled blood pressure managementOther
The intervention will consist of a technology-enabled remote hypertension management program.
| Study group | Role | What they receive |
|---|---|---|
| Technology-enabled blood pressure management | Experimental | The intervention will consist of a technology-enabled remote hypertension management program. Participants will be given a cellular blood pressure (BP) cuff and patients with heart failure and chronic kidney disease stage 3b-5 will be given a scale also. Patients will undergo a series of protocolized software-driven medication initiation and titration steps until they reach a blood pressure target of systolic blood pressure < 130 mmHg and diastolic blood pressure < 80 mmHg. Patients will be subsequently monitored for up to 12 more months. If their blood pressure increases, they can re-enter active management. Receives: Other: Technology-enabled blood pressure management |
| No intervention | No intervention | Patients meeting inclusion care undergoing usual care in control clinics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in SBP change
Difference in mean change in systolic blood pressure (SBP)
Measured: 6 months after enrollment
Secondary outcomes (2)
HEDIS proportion
Difference in the proportion of patients meeting HEDIS definition of controlled hypertension (SBP < 140 AND DBP < 90) between intervention and usual care: overall and by patient group and by age, race, sex strata
Measured: 6 months after enrollment
Difference in DBP change
Difference in mean change in diastolic blood pressure (DBP)
Measured: 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start18 Mar 2024 (estimated)
- Primary completion17 Sep 2025 (estimated)
- Study completion17 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- non-blinded pragmatic cluster-randomized controlled trial with a single intervention
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atman Health, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331754
- Sponsor's protocol ID
- ATMANHEALTH001
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-Enabled Remote Hypertension Management To Advance Health Equity
- ClinicalTrials.gov ID
- NCT06331754
- Acronym / sponsor ID
- ATMANHEALTH001
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Atman Health, IncIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2024 (estimated)
- Primary completion
- 17 Sep 2025 (estimated)
- Study completion
- 17 Mar 2026 (estimated)
- First posted
- 26 Mar 2024 (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 primary objective of this study is to reliably estimate the difference in blood pressure control of a technology-enabled solution for blood pressure (BP) management over usual care. The study will also assess patient and provider satisfaction with the solution. Finally, the investigators will estimate the economic impact of the intervention in terms of resource utilization.
Detailed description
The study design is a non-blinded pragmatic cluster-randomized controlled trial with a single intervention. Participants with uncontrolled hypertension will be identified from a randomly selected group of primary care clinics. Participants from half of the clinics will be enrolled in the intervention arm while the others will receive usual care. Participants in the intervention arm will undergo a series of software-driven medication initiation and titration steps until they reach a blood pressure target of systolic blood pressure < 130 mmHg and diastolic blood pressure < 80 mmHg. Participants will be subsequently monitored for up to 12 more months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- non-blinded pragmatic cluster-randomized controlled trial with a single intervention
| Arm | Type | Receives |
|---|---|---|
| Technology-enabled blood pressure management | Experimental | Other: Technology-enabled blood pressure managementThe intervention will consist of a technology-enabled remote hypertension management program. Participants will be given a cellular blood pressure (BP) cuff and patients with heart failure and chronic kidney disease stage 3b-5 will be given a scale also. Patients will undergo a series of protocolized software-driven medication initiation and titration steps until they reach a blood pressure target of systolic blood pressure < 130 mmHg and diastolic blood pressure < 80 mmHg. Patients will be subsequently monitored for up to 12 more months. If their blood pressure increases, they can re-enter active management. |
| No intervention | No intervention | –Patients meeting inclusion care undergoing usual care in control clinics. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years - 100 years
- uncontrolled hypertension: as defined as SBP > 140 or DBP > 90 on 2 successive clinic visits
Key exclusion criteria (6 listed)
- hearing impaired
- visually impaired
- cognitively impaired
- hospice care
- on hemodialysis at enrollment
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 |
|---|---|---|
| Technology-enabled blood pressure managementThe intervention will consist of a technology-enabled remote hypertension management program. | Other | Technology-enabled blood pressure management |
Primary outcome
Difference in SBP change
Time frame: 6 months after enrollment
Difference in mean change in systolic blood pressure (SBP)
2 secondary outcomes
HEDIS proportion
Time frame: 6 months after enrollment
Difference in DBP change
Time frame: 6 months after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-enabled blood pressure management in people with Hypertension, run by Atman Health, Inc.
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 6 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: status not confirmed, as of the sponsor's last update on 26 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rahul C Deo, MD PhD (339-204-5454, rahul@atmanhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in SBP change (time frame: 6 months after enrollment). 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 26 Mar 2024.