HypertensionSupportBPNCT03416283
Remote Monitoring and Social Support for Hypertension Management
A study testing Remote Monitoring and Remote Monitoring + Social Support in people with Hypertension, run by University of Pennsylvania at 1 site in United States.
Trial summary
A 3-arm randomized pilot trial aimed at comparing the effectiveness of different remote approaches to improving blood pressure (BP) control. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Remote Monitoring and Remote Monitoring + Social Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2018to 26 Oct 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 75 years old with HTN (ICD-10 code I10)
- Has had at least two office visits at Penn Family Care (PFC) within the past 12 months (at time of chart review), with at least two of the visits with BP readings exceeding HTN guidelines, including the last visit (150/90 or 140/90 if ages 21-59 yrs with CKD or diabetes)
- Must have a cellular phone with texting capabilities
- Must be prescribed at least one medication for hypertension
Who cannot join
- Has metastatic (Stage IV) blood or solid tumor cancer
- Has end stage renal disease
- Has congestive heart failure
- Has dementia
- Has liver cirrhosis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Remote Monitoring and Enhanced Social Support for Hypertension Management
A 3-arm randomized pilot trial aimed at comparing the effectiveness of different remote approaches to improving blood pressure (BP) control.
Read the detailed description
The investigators plan to leverage the Way to Health (WTH) platform to develop and evaluate a new HTN service-delivery model that is integrated with routine clinical care at Penn Family Care (PFC), an academic family medicine practice in West Philadelphia. Among patients with poorly controlled HTN:
- The investigators will assess the effects of monitoring blood pressure and medication adherence with feedback to the patient and to the clinical practice, as needed if out of control.
- The investigators will also compare the impact of providing feedback to a social support partner with facilitated cheerleading.
- Conditions
- Hypertension
- Being tested
- Remote Monitoring, Remote Monitoring + Social Support
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote MonitoringBehavioural
Remote BP monitoring and medication adherence
Remote Monitoring + Social SupportBehavioural
Remote BP monitoring and medication adherence with enhanced support from a support partner ("facilitated cheerleading")
| Study group | Role | What they receive |
|---|---|---|
| Remote Monitoring (RM) | Experimental | Remote Monitoring subjects will receive a blood pressure cuff and bidirectional text messaging regarding blood pressure and medication adherence. Receives: Behavioral: Remote Monitoring |
| Remote Monitoring + Social Support (RM+SS) | Experimental | Remote Monitoring + Social Support subjects will receive a blood pressure cuff and bidirectional text messaging regarding blood pressure and medication adherence, as well as a social support partner to provide additional feedback to the participant on their monitoring and adherence practices. Receives: Behavioral: Remote Monitoring + Social Support |
| Usual Care | No intervention | Usual care subjects will not receive a blood pressure cuff or bidirectional text messaging. They will be asked to take their medication and monitor BP as usual with no additional contact from study staff until the 4 month study follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Systolic blood pressure during the 4-month study visit, adjusted for initial systolic blood pressure
Measured: 4 months
Secondary outcomes (3)
Percent of patients that are normotensive
The percent of patients with final blood pressure within the normal range.
Measured: 4 months
Medication adherence
Medication adherence as measured by the text message response
Measured: 4 months
Diastolic blood pressure
Adjusted for initial diastolic blood pressure
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start20 May 2018
- Primary completion26 Oct 2019
- Study completion26 Oct 2019
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 HypertensionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shivan Mehta, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416283
- Sponsor's protocol ID
- 828417
- Acronym
- SupportBP
- Status last verified
- Aug 2022
- First submitted
- 17 Jan 2018
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mehta SJ, Volpp KG, Troxel AB, Teel J, Reitz CR, Purcell A, Shen H, McNelis K, Snider CK, Asch DA. Remote Blood Pressure Monitoring With Social Support for Patients With Hypertension: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2413515. doi: 10.1001/jamanetworkopen.2024.13515.
PubMed 38829618
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Monitoring and Enhanced Social Support for Hypertension Management
- ClinicalTrials.gov ID
- NCT03416283
- Acronym / sponsor ID
- SupportBP / 828417
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 20 May 2018 (actual)
- Primary completion
- 26 Oct 2019 (actual)
- Study completion
- 26 Oct 2019 (actual)
- First posted
- 31 Jan 2018 (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.
A 3-arm randomized pilot trial aimed at comparing the effectiveness of different remote approaches to improving blood pressure (BP) control.
Detailed description
The investigators plan to leverage the Way to Health (WTH) platform to develop and evaluate a new HTN service-delivery model that is integrated with routine clinical care at Penn Family Care (PFC), an academic family medicine practice in West Philadelphia. Among patients with poorly controlled HTN:
- The investigators will assess the effects of monitoring blood pressure and medication adherence with feedback to the patient and to the clinical practice, as needed if out of control.
- The investigators will also compare the impact of providing feedback to a social support partner with facilitated cheerleading.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remote Monitoring (RM) | Experimental | Behavioral: Remote MonitoringRemote Monitoring subjects will receive a blood pressure cuff and bidirectional text messaging regarding blood pressure and medication adherence. |
| Remote Monitoring + Social Support (RM+SS) | Experimental | Behavioral: Remote Monitoring + Social SupportRemote Monitoring + Social Support subjects will receive a blood pressure cuff and bidirectional text messaging regarding blood pressure and medication adherence, as well as a social support partner to provide additional feedback to the participant on their monitoring and adherence practices. |
| Usual Care | No intervention | –Usual care subjects will not receive a blood pressure cuff or bidirectional text messaging. They will be asked to take their medication and monitor BP as usual with no additional contact from study staff until the 4 month study follow-up. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between 18 and 75 years old with HTN (ICD-10 code I10)
- Has had at least two office visits at Penn Family Care (PFC) within the past 12 months (at time of chart review), with at least two of the visits with BP readings exceeding HTN guidelines, including the last visit (150/90 or 140/90 if ages 21-59 yrs with CKD or diabetes)
- Must have a cellular phone with texting capabilities
- Must be prescribed at least one medication for hypertension
Key exclusion criteria (5 listed)
- Has metastatic (Stage IV) blood or solid tumor cancer
- Has end stage renal disease
- Has congestive heart failure
- Has dementia
- Has liver cirrhosis
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 |
|---|---|---|
| Remote MonitoringRemote BP monitoring and medication adherence | Behavioural | Remote Monitoring (RM) |
| Remote Monitoring + Social SupportRemote BP monitoring and medication adherence with enhanced support from a support partner ("facilitated cheerleading") | Behavioural | Remote Monitoring + Social Support (RM+SS) |
Primary outcome
Systolic blood pressure
Time frame: 4 months
Systolic blood pressure during the 4-month study visit, adjusted for initial systolic blood pressure
3 secondary outcomes
Percent of patients that are normotensive
Time frame: 4 months
Medication adherence
Time frame: 4 months
Diastolic blood pressure
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Derived from this study: PubMed 38829618Mehta SJ, Volpp KG, Troxel AB, Teel J, Reitz CR, Purcell A, Shen H, McNelis K, Snider CK, Asch DA. Remote Blood Pressure Monitoring With Social Support for Patients With Hypertension: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2413515. doi: 10.1001/jamanetworkopen.2024.13515.
- 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. This study is not recruiting at the moment.
Shivan Mehta, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Monitoring and Remote Monitoring + Social Support in people with Hypertension, run by University of Pennsylvania 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 31 Aug 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (time frame: 4 months). 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 NCT03416283, 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 31 Aug 2022.