High Blood PressureHoMENCT03650166
High BP and Home Monitoring Experience (HoME) Study
A study testing MyBP and Personal BP monitor in people with High Blood Pressure, run by University of Pittsburgh at 1 site in United States.
Trial summary
High blood pressure is a leading risk factor for cardiovascular and kidney disease, yet is uncontrolled in half of affected individuals, and specifically older adults. The investigators have developed an automated program for patient education and personalized assistance of systematic home BP self-monitoring. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- High Blood Pressure
- What is being tested?
- MyBP and Personal BP monitor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2018to 30 Aug 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of High blood pressure
- Office systolic BP reading 150 mm Hg or higher
- Owns a cell phone with unlimited texting
Who cannot join
- Arm circumference > 45 cm
- Dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
Official title: Adoption and Effectiveness of a mHealth Intervention for Hypertension in Older Adults: a Pilot Clinical Trial
High blood pressure is a leading risk factor for cardiovascular and kidney disease, yet is uncontrolled in half of affected individuals, and specifically older adults. The investigators have developed an automated program for patient education and personalized assistance of systematic home BP self-monitoring. Reports are sent to primary care providers at regular intervals. This investigation will collect pilot data on feasibility and effectiveness in older adults with and without a caregiver.
Read the detailed description
Background. Hypertension is a highly prevalent condition and a primary cause of heart disease, kidney failure and cognitive decline. Hypertension is uncontrolled in nearly half of diagnosed adults in the US, with the lowest control rates among older adults (i.e., over 60 y/o). Uncontrolled hypertension is attributable to a mix of factors, most notably suboptimal self-management among patients and clinical inertia due to the reliance on limited BP measurement at office visits, which results in diagnostic uncertainty.
Home BP monitoring (HBPM) is a promising solution to catalyze patient engagement in self-management while offering clinicians reliable and up-to-date data, thereby improving clinical management. Home blood pressure monitoring (HBPM) is now widely recommended as an effective additional tool for improved hypertension management, however broad implementation has not occurred. The convenience of mobile phones has led to high and increasing ownership among all age groups, thus there is great potential to leverage mobile health (mHealth) applications to make HBPM easy, convenient, and even more helpful for both clinicians and patients.
Based upon extensive stakeholder input, the investigators' multidisciplinary team designed a comprehensive mobile phone supported HBPM system called MyBP. MyBP efficiently educates patients via professionally-developed videos and supports bi-weekly BP self-monitoring with recurring feedback using proactive, bidirectional automated texting. Prior pilot testing at three unique clinical sites with middle-aged adults (mean 50 y/o) suggests good usability and positive effects on self-management behaviors. High priority next steps are to: 1) test MyBP specifically with older adults (and caregivers) to fully understand their unique experiences in regards to HBPM via mobile phone, and 2) explore how best to share MyBP data with primary care providers (PCPs). Therefore, the aims of this study are to:
- Collect pilot data on longitudinal usage of MyBP and BP reduction over 6-9 months within an older adult population.
- Examine factors influencing adoption and sustained use of MyBP and any associated BP reduction.
- Identify potentially unique user experiences among older adults with increasing frailty and in those who rely on caregivers.
Methods. Forty-eight older adults (60-85 y/o) with uncontrolled hypertension will be randomized 2:1 to active intervention (MyBP plus a home BP cuff) or usual care (home BP cuff alone) for 6-9 months. Participants will be recruited from UPMC primary care practices. For participants for whom a caregiver has primary responsibility for hypertension-related health behaviors, MyBP will be used by the caregiver. Gait speed will be measured to assess frailty. At baseline and study completion, standardized measurement of home BP will be conducted. Patients and caregivers will complete questionnaires and a semi-structured audio-recorded interview to assess factors associated with MyBP utility and engagement, BP self-management and BP lowering.
Future use of data. Findings will be used to refine the MyBP system design to best fit the target audience and as "preliminary evidence" in an NIH R01 proposal to test in a randomized clinical trial of MyBP in the primary care setting among both mid-life and older adults with uncontrolled hypertension.
- Conditions
- High Blood Pressure
- Being tested
- MyBP, Personal BP monitor
- Keywords
- mhealth, short-messaging system, self-management, home blood pressure monitoring, health literacy
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyBPOther
This program includes online video high BP education and longitudinal, personalized assistance of home BP self-monitoring.
Personal BP monitorOther
Also called A&D Medical Blood Pressure Monitor, model UA-767FAC
Battery-powered BP monitor for personal use
| Study group | Role | What they receive |
|---|---|---|
| Enhanced usual care | Active comparator | Participants receive a personal, validated home BP monitor with oral and written instruction. Receives: Other: Personal BP monitor |
| MyBP | Experimental | Participants receive a personal, validated home BP monitor with oral and written instruction. In addition patients receive instruction on, and access to, MyBP. This program provides high BP education through online videos and automated, bidirectional text messaging to assist in continuous home BP self-monitoring. Receives: Other: MyBP; Other: Personal BP monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic BP from baseline to trial completion
Seated BP will be measured in duplicate during each of two baseline assessments (4 total readings) and again in duplicate at each of two assessments at trial completion (4 readings). The primary outcome is the change in average systolic BP from baseline to follow-up. This will be calculated as the average systolic BP at follow-up minus the average systolic BP at baseline. The change in BP in two intervention groups will be compared.
Measured: 5-8 months (Trial duration is not identical across participants but is anticipated to be between 5 and 8 months.)
Secondary outcomes (2)
Change in participants' hypertension self-efficacy (confidence in ability to fully understand and manage his or her high BP)
Hypertension self-efficacy will be assessed at baseline and trial completion with this question: Please rate your confidence in your ability to fully understand and manage your high BP. [No confidence; A little confidence; Some confidence; High confidence; Very high confidence.] Answers are scored 1-5. Change in score will be compared across the two intervention groups.
Measured: 5-8 months
Change in systolic BP from baseline to trial mid-point
Seated BP will be measured in duplicate during each of two baseline assessments (4 total readings) and also during two assessments at trial mid-point (4 readings). This secondary outcome is the change in average systolic BP from baseline to trial mid-point. This will be calculated as the average systolic BP at mid-point minus the average systolic BP at baseline. The change in BP in two intervention groups will be compared.
Measured: Approximately 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start21 Sep 2018
- Primary completion2 Aug 2019
- Study completion30 Aug 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 High Blood PressureStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Muldoon, University of Pittsburgh
- Investigators
- Matthew F Muldoon, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650166
- Sponsor's protocol ID
- PRO18050328
- Acronym
- HoME
- Status last verified
- Oct 2019
- First submitted
- 23 Aug 2018
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Einhorn J, Murphy AR, Rogal SS, Suffoletto B, Irizarry T, Rollman BL, Forman DE, Muldoon MF. Automated Messaging Program to Facilitate Systematic Home Blood Pressure Monitoring: Qualitative Analysis of Provider Interviews. JMIR Cardio. 2023 Dec 4;7:e51316. doi: 10.2196/51316.
PubMed 38048147
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adoption and Effectiveness of a mHealth Intervention for Hypertension in Older Adults: a Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT03650166
- Acronym / sponsor ID
- HoME / PRO18050328
- Conditions
- High Blood Pressure
- Keywords
- mhealth, short-messaging system, self-management, home blood pressure monitoring, health literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 2 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 28 Aug 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.
High blood pressure is a leading risk factor for cardiovascular and kidney disease, yet is uncontrolled in half of affected individuals, and specifically older adults. The investigators have developed an automated program for patient education and personalized assistance of systematic home BP self-monitoring. Reports are sent to primary care providers at regular intervals. This investigation will collect pilot data on feasibility and effectiveness in older adults with and without a caregiver.
Detailed description
Background. Hypertension is a highly prevalent condition and a primary cause of heart disease, kidney failure and cognitive decline. Hypertension is uncontrolled in nearly half of diagnosed adults in the US, with the lowest control rates among older adults (i.e., over 60 y/o). Uncontrolled hypertension is attributable to a mix of factors, most notably suboptimal self-management among patients and clinical inertia due to the reliance on limited BP measurement at office visits, which results in diagnostic uncertainty.
Home BP monitoring (HBPM) is a promising solution to catalyze patient engagement in self-management while offering clinicians reliable and up-to-date data, thereby improving clinical management. Home blood pressure monitoring (HBPM) is now widely recommended as an effective additional tool for improved hypertension management, however broad implementation has not occurred. The convenience of mobile phones has led to high and increasing ownership among all age groups, thus there is great potential to leverage mobile health (mHealth) applications to make HBPM easy, convenient, and even more helpful for both clinicians and patients.
Based upon extensive stakeholder input, the investigators' multidisciplinary team designed a comprehensive mobile phone supported HBPM system called MyBP. MyBP efficiently educates patients via professionally-developed videos and supports bi-weekly BP self-monitoring with recurring feedback using proactive, bidirectional automated texting. Prior pilot testing at three unique clinical sites with middle-aged adults (mean 50 y/o) suggests good usability and positive effects on self-management behaviors. High priority next steps are to: 1) test MyBP specifically with older adults (and caregivers) to fully understand their unique experiences in regards to HBPM via mobile phone, and 2) explore how best to share MyBP data with primary care providers (PCPs). Therefore, the aims of this study are to:
- Collect pilot data on longitudinal usage of MyBP and BP reduction over 6-9 months within an older adult population.
- Examine factors influencing adoption and sustained use of MyBP and any associated BP reduction.
- Identify potentially unique user experiences among older adults with increasing frailty and in those who rely on caregivers.
Methods. Forty-eight older adults (60-85 y/o) with uncontrolled hypertension will be randomized 2:1 to active intervention (MyBP plus a home BP cuff) or usual care (home BP cuff alone) for 6-9 months. Participants will be recruited from UPMC primary care practices. For participants for whom a caregiver has primary responsibility for hypertension-related health behaviors, MyBP will be used by the caregiver. Gait speed will be measured to assess frailty. At baseline and study completion, standardized measurement of home BP will be conducted. Patients and caregivers will complete questionnaires and a semi-structured audio-recorded interview to assess factors associated with MyBP utility and engagement, BP self-management and BP lowering.
Future use of data. Findings will be used to refine the MyBP system design to best fit the target audience and as "preliminary evidence" in an NIH R01 proposal to test in a randomized clinical trial of MyBP in the primary care setting among both mid-life and older adults with uncontrolled hypertension.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced usual care | Active comparator | Other: Personal BP monitorParticipants receive a personal, validated home BP monitor with oral and written instruction. |
| MyBP | Experimental | Other: MyBP, Other: Personal BP monitorParticipants receive a personal, validated home BP monitor with oral and written instruction. In addition patients receive instruction on, and access to, MyBP. This program provides high BP education through online videos and automated, bidirectional text messaging to assist in continuous home BP self-monitoring. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of High blood pressure
- Office systolic BP reading 150 mm Hg or higher
- Owns a cell phone with unlimited texting
Key exclusion criteria (2 listed)
- Arm circumference > 45 cm
- Dementia
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 |
|---|---|---|
| MyBPThis program includes online video high BP education and longitudinal, personalized assistance of home BP self-monitoring. | Other | MyBP |
| Personal BP monitorAlso: A&D Medical Blood Pressure Monitor, model UA-767FACBattery-powered BP monitor for personal use | Other | Enhanced usual care, MyBP |
Primary outcome
Change in systolic BP from baseline to trial completion
Time frame: 5-8 months (Trial duration is not identical across participants but is anticipated to be between 5 and 8 months.)
Seated BP will be measured in duplicate during each of two baseline assessments (4 total readings) and again in duplicate at each of two assessments at trial completion (4 readings). The primary outcome is the change in average systolic BP from baseline to follow-up. This will be calculated as the average systolic BP at follow-up minus the average systolic BP at baseline. The change in BP in two intervention groups will be compared.
2 secondary outcomes
Change in participants' hypertension self-efficacy (confidence in ability to fully understand and manage his or her high BP)
Time frame: 5-8 months
Change in systolic BP from baseline to trial mid-point
Time frame: Approximately 14 weeks
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 25 Oct 2019.
- Derived from this study: PubMed 38048147Einhorn J, Murphy AR, Rogal SS, Suffoletto B, Irizarry T, Rollman BL, Forman DE, Muldoon MF. Automated Messaging Program to Facilitate Systematic Home Blood Pressure Monitoring: Qualitative Analysis of Provider Interviews. JMIR Cardio. 2023 Dec 4;7:e51316. doi: 10.2196/51316.
- 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.
Matthew F Muldoon, MD 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 MyBP and Personal BP monitor in people with High Blood Pressure, 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 3 inclusion and 2 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 25 Oct 2019. 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?
Change in systolic BP from baseline to trial completion (time frame: 5-8 months (Trial duration is not identical across participants but is anticipated to be between 5 and 8 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 NCT03650166, 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 25 Oct 2019.