High BP and Home Monitoring Experience (HoME) Study
Status: | Recruiting |
---|---|
Conditions: | High Blood Pressure (Hypertension) |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 60 - Any |
Updated: | 9/28/2018 |
Start Date: | September 21, 2018 |
End Date: | August 30, 2019 |
Contact: | Matthew F Muldoon, MD |
Email: | mfm10@pitt.edu |
Phone: | 4126248798 |
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.
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.
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:
1. Collect pilot data on longitudinal usage of MyBP and BP reduction over 6-9 months within
an older adult population.
2. Examine factors influencing adoption and sustained use of MyBP and any associated BP
reduction.
3. 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.
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:
1. Collect pilot data on longitudinal usage of MyBP and BP reduction over 6-9 months within
an older adult population.
2. Examine factors influencing adoption and sustained use of MyBP and any associated BP
reduction.
3. 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.
Inclusion Criteria:
- Diagnosis of High blood pressure
- Office systolic BP reading 150 mm Hg or higher
- Owns a cell phone with unlimited texting
Exclusion Criteria:
- Arm circumference > 45 cm
- Dementia
We found this trial at
1
site
4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: Matthew F. Muldoon, MD, MPH
Phone: 412-624-7728
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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