Clinical trial NCT03650166: High BP and Home Monitoring Experience (HoME) Study
Official title: Adoption and Effectiveness of a mHealth Intervention for Hypertension in Older Adults: a Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Blood Pressure
Keywords: mhealth
short-messaging system
self-management
home blood pressure monitoring
health literacy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 62
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in systolic BP from baseline to trial completion
timeFrame: 5-8 months (Trial duration is not identical across participants but is anticipated to be between 5 and 8 months.)
Secondary outcomes:
measure: Change in participants' hypertension self-efficacy (confidence in ability to fully understand and manage his or her high BP)
timeFrame: 5-8 months
measure: Change in systolic BP from baseline to trial mid-point
timeFrame: Approximately 14 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Matthew F Muldoon, MD
role: PRINCIPAL_INVESTIGATOR
References: