NCT03650166

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

September 21, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

October 25, 2019

Status Verified

October 1, 2019

Enrollment Period

11 months

First QC Date

August 23, 2018

Last Update Submit

October 23, 2019

Conditions

High Blood Pressure

Keywords

mhealthshort-messaging systemself-managementhome blood pressure monitoringhealth literacy

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    5-8 months

  • Change in systolic BP from baseline to trial mid-point

    Approximately 14 weeks

Study Arms (2)

Enhanced usual care

ACTIVE COMPARATOR

Participants receive a personal, validated home BP monitor with oral and written instruction.

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.

Other: MyBPOther: Personal BP monitor

Interventions

MyBPOTHER

This program includes online video high BP education and longitudinal, personalized assistance of home BP self-monitoring.

MyBP
Personal BP monitorOTHER

Battery-powered BP monitor for personal use

Also known as: A&D Medical Blood Pressure Monitor, model UA-767FAC
Enhanced usual careMyBP

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of High blood pressure
  • Office systolic BP reading 150 mm Hg or higher
  • Owns a cell phone with unlimited texting

You may not qualify if:

  • Arm circumference \> 45 cm
  • Dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (1)

  • 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.

    PMID: 38048147DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Matthew F Muldoon, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessor will be blinded to group assignment
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 23, 2018

First Posted

August 28, 2018

Study Start

September 21, 2018

Primary Completion

August 2, 2019

Study Completion

August 30, 2019

Last Updated

October 25, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)