HypertensionNCT04714398
SupportBP 2.0:Behavioral Science and Enrollment in Remote Monitoring for Hypertension Management
A study testing Opt-In Recruitment and Opt-Out Recruitment 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 approaches to recruiting patients to participate in a 6-month remote monitoring program for the management of hypertension (HTN). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Opt-In Recruitment and Opt-Out Recruitment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 425 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2021to 26 Aug 2022
- 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 one office visit at Penn Family Care (PFC) within the past 12 months (at time of chart review), with the last visit having a BP reading exceeding HTN guidelines (150/90 if >60 or, 140/90 if ages 21-59 yrs or has 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) cancer
- Has end stage renal disease
- Has congestive heart failure
- Has dementia
- BMI >= 50
- Is Non-English speaking requiring a translator
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: SupportBP 2.0: Behavioral Science and Enrollment in Remote Monitoring for Hypertension Management
A 3-arm randomized pilot trial aimed at comparing the effectiveness of different approaches to recruiting patients to participate in a 6-month remote monitoring program for the management of hypertension (HTN).
Read the detailed description
The investigators will utilize the Way to Health (WTH) platform to develop and evaluate a new remote monitoring enrollment 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:
- Compare the effect of sending eligible patients a blood pressure cuff with the mailed invitation letter and opt-out framing versus the more conventional method of phone calls following mailed letters.
- Evaluate the feasibility and effectiveness of a remote monitoring program with individualized stepped escalation for hypertension management.
- Conditions
- Hypertension
- Being tested
- Opt-In Recruitment, Opt-Out Recruitment
- Keywords
- blood pressure, remote monitoring
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opt-In RecruitmentBehavioural
Patients in the opt-in recruitment arm will receive a letter describing the program and inviting them to participate in the remote monitoring program. Along with the letter they will receive an informational brochure and a copy of the informed consent form. Patients in this arm will then receive a recruitment phone call explaining the program and consenting the participant verbally. If the participant consents to participate in the remote monitoring program, to receive text messaging, and to connection to care, the research coordinator will mail a blood pressure cuff and begin the remote monitoring program for the patient 6 days later.
Opt-Out RecruitmentBehavioural
Patients assigned to opt-out recruitment will receive a blood pressure cuff with instructions in the mail along with a letter describing the program and opt-out framing regarding their participation, as well as a brochure and a copy of the informed consent form. Patients in this arm will receive a recruitment phone call similar to recruitment arm A, explaining the program and consenting the participant verbally. If the participant consents to participate in the remote monitoring program, to receive text messaging, and to connection to care, the research coordinator will begin the remote monitoring program for the patient immediately.
| Study group | Role | What they receive |
|---|---|---|
| Opt-In Recruitment | Experimental | All recruitment messaging will be framed for patients as they must opt-in to participate in the remote monitoring program. Receives: Behavioral: Opt-In Recruitment |
| Opt-Out | Experimental | All recruitment messaging will be framed as though participation is the default, and patients must opt-out of participating in the remote monitoring program. Receives: Behavioral: Opt-Out Recruitment |
| Usual Care | No intervention | Patients in the usual care arm will not be contacted by study staff, they will not receive a blood pressure cuff, and they will not be asked to participate in any component of the blood pressure monitoring program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion Participating by Recruitment Method
The proportion of patients participating in each study arm out of the number randomized to that study arm.
Measured: 6 months, from date of consent to end of remote monitoring program
Secondary outcomes (4)
Proportion Engaged by Recruitment Method
The proportion of patients recruited by each method who are actively engaged with the program
Measured: 6 months, from date of consent to end of remote monitoring period
Proportion with Controlled Blood Pressure by Monitoring vs. Usual Care
The proportion with controlled blood pressure by remote monitoring and the proportion with controlled blood pressure by clinic visits (usual care).
Measured: 6 months, from date of consent to end of remote monitoring program
Blood Pressure Trajectory by Recruitment Method
The systolic and diastolic blood pressure trajectory by recruitment arm.
Measured: 6 months, from date of consent to end of remote monitoring program
Proportion of BP Measurements Submitted by Recruitment Method
The proportion of requested BP measurements submitted by each patient by recruitment arm
Measured: 6 months, from date of consent to end of remote monitoring program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start26 Feb 2021
- Primary completion21 Mar 2022
- Study completion26 Aug 2022
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shivan J Mehta, University of Pennsylvania
- Investigators
- Shivan Mehta, MD, MBA, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714398
- Sponsor's protocol ID
- 844150
- Status last verified
- Sep 2022
- First submitted
- 12 Jan 2021
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mehta SJ, Teel J, Okorie E, Reitz C, Purcell A, Snider CK, Clark K, Kersting RC, Glanz K, Putt M, Rareshide C, Volpp KG. Behavioral Economic Framing for Enrollment and Retention of Patients in Remote Blood Pressure Monitoring: A Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2529825. doi: 10.1001/jamanetworkopen.2025.29825.
PubMed 40892409
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SupportBP 2.0: Behavioral Science and Enrollment in Remote Monitoring for Hypertension Management
- ClinicalTrials.gov ID
- NCT04714398
- Acronym / sponsor ID
- 844150
- Conditions
- Hypertension
- Keywords
- blood pressure, remote monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 21 Mar 2022 (actual)
- Study completion
- 26 Aug 2022 (actual)
- First posted
- 19 Jan 2021 (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 approaches to recruiting patients to participate in a 6-month remote monitoring program for the management of hypertension (HTN).
Detailed description
The investigators will utilize the Way to Health (WTH) platform to develop and evaluate a new remote monitoring enrollment 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:
- Compare the effect of sending eligible patients a blood pressure cuff with the mailed invitation letter and opt-out framing versus the more conventional method of phone calls following mailed letters.
- Evaluate the feasibility and effectiveness of a remote monitoring program with individualized stepped escalation for hypertension management.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Opt-In Recruitment | Experimental | Behavioral: Opt-In RecruitmentAll recruitment messaging will be framed for patients as they must opt-in to participate in the remote monitoring program. |
| Opt-Out | Experimental | Behavioral: Opt-Out RecruitmentAll recruitment messaging will be framed as though participation is the default, and patients must opt-out of participating in the remote monitoring program. |
| Usual Care | No intervention | –Patients in the usual care arm will not be contacted by study staff, they will not receive a blood pressure cuff, and they will not be asked to participate in any component of the blood pressure monitoring program. |
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 one office visit at Penn Family Care (PFC) within the past 12 months (at time of chart review), with the last visit having a BP reading exceeding HTN guidelines (150/90 if >60 or, 140/90 if ages 21-59 yrs or has CKD or diabetes).
- Must have a cellular phone with texting capabilities
- Must be prescribed at least one medication for hypertension
Key exclusion criteria (6 listed)
- Has metastatic (Stage IV) cancer
- Has end stage renal disease
- Has congestive heart failure
- Has dementia
- BMI >= 50
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 |
|---|---|---|
| Opt-In RecruitmentPatients in the opt-in recruitment arm will receive a letter describing the program and inviting them to participate in the remote monitoring program. Along with the letter they will receive an informational brochure and a copy of the informed consent form. Patients in this arm will then receive a recruitment phone call explaining the program and consenting the participant verbally. If the participant consents to participate in the remote monitoring program, to receive text messaging, and to connection to care, the research coordinator will mail a blood pressure cuff and begin the remote monitoring program for the patient 6 days later. | Behavioural | Opt-In Recruitment |
| Opt-Out RecruitmentPatients assigned to opt-out recruitment will receive a blood pressure cuff with instructions in the mail along with a letter describing the program and opt-out framing regarding their participation, as well as a brochure and a copy of the informed consent form. Patients in this arm will receive a recruitment phone call similar to recruitment arm A, explaining the program and consenting the participant verbally. If the participant consents to participate in the remote monitoring program, to receive text messaging, and to connection to care, the research coordinator will begin the remote monitoring program for the patient immediately. | Behavioural | Opt-Out |
Primary outcome
Proportion Participating by Recruitment Method
Time frame: 6 months, from date of consent to end of remote monitoring program
The proportion of patients participating in each study arm out of the number randomized to that study arm.
4 secondary outcomes
Proportion Engaged by Recruitment Method
Time frame: 6 months, from date of consent to end of remote monitoring period
Proportion with Controlled Blood Pressure by Monitoring vs. Usual Care
Time frame: 6 months, from date of consent to end of remote monitoring program
Blood Pressure Trajectory by Recruitment Method
Time frame: 6 months, from date of consent to end of remote monitoring program
Proportion of BP Measurements Submitted by Recruitment Method
Time frame: 6 months, from date of consent to end of remote monitoring program
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 19 Sep 2022.
- Derived from this study: PubMed 40892409Mehta SJ, Teel J, Okorie E, Reitz C, Purcell A, Snider CK, Clark K, Kersting RC, Glanz K, Putt M, Rareshide C, Volpp KG. Behavioral Economic Framing for Enrollment and Retention of Patients in Remote Blood Pressure Monitoring: A Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2529825. doi: 10.1001/jamanetworkopen.2025.29825.
- 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, MBA 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 Opt-In Recruitment and Opt-Out Recruitment 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 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: finished, as of the sponsor's last update on 19 Sep 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?
Proportion Participating by Recruitment Method (time frame: 6 months, from date of consent to end of remote monitoring program). 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 NCT04714398, 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 19 Sep 2022.