Mobile Health Management of Hypertension
Mobile Health for Enhanced Hypertension Self-Management
2 other identifiers
interventional
40
1 country
1
Brief Summary
The investigators will pilot test a hypertension self-management intervention for feasibility and acceptability. The investigators will enroll adults (age ≥18) with uncontrolled hypertension, identified from the electronic health record. In this feasibility trial, the research aim is to explore trial design, participant acceptability of the intervention and outcome measures, and to generate data to inform the design of a future randomized controlled trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hypertension
Started Sep 2027
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2023
CompletedFirst Posted
Study publicly available on registry
May 12, 2023
CompletedStudy Start
First participant enrolled
September 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
Study Completion
Last participant's last visit for all outcomes
November 1, 2028
June 6, 2025
May 1, 2025
11 months
May 3, 2023
June 3, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Participant acceptance and adherence to program
80% of participants receiving intervention will have strong engagement, defined by \>60 logins
90 days
Participant satisfaction and usability
80% of participants receiving intervention will indicate talking with the coach was easy on a 7-point Likert scale (1=Easy; 7=Difficult)
90 days post index discharge
Practicality of participant self-monitoring behavior
80% of participants receiving intervention will have recorded their BP \>60 times
90 days
Secondary Outcomes (5)
Locus of control
90 days
Resilience
90 days
Medication Adherence
90 days
Blood pressure change
90 days
Blood pressure control
90 days
Study Arms (2)
Enhanced Usual Care
ACTIVE COMPARATORThe active comparison group will receive a smartphone with the WebMD® health information application preloaded and a BP monitor. After recruitment, participants will receive a confirmatory interview, informed consent, and baseline device training via telephone, delivered by an experienced research assistant. Participants will be encouraged to complete 1 morning BP reading daily, irrespective of study arm. BP readings are automatically uploaded via Bluetooth to a centralized, secure platform to be accessible to the study PI.
Behavioral mHealth Coaching Intervention
EXPERIMENTALThose randomized to the intervention group will receive a smartphone with the intervention program preloaded in addition to a BP monitor. After recruitment, participants will receive a confirmatory interview, informed consent, and baseline device training via telephone, delivered by an experienced research assistant. Participants will be encouraged to complete 1 morning BP reading daily, irrespective of study arm, however, only the intervention group will receive reminders from the mHealth coaching intervention to check BP daily. BP readings are automatically uploaded via Bluetooth to a centralized, secure platform to be accessible to the study PI.
Interventions
The intervention uses a mHealth virtual tool that facilitates human-device interaction and is delivered by smartphone application. The program has coaching and education components that lead to chronic disease behavior change. It has been previously validated to improve self-management, medication adherence, and quality of life in individuals with CVD. The participant engages by selecting responses on the touch screen. In this manner, participants converse with the coach, develop a therapeutic alliance, and record responses. The investigators will institute behavior change methodology to enhance intervention efficacy.
Smart phone without health coach. A basic health application is installed on the smart phone provided to the participant.
Eligibility Criteria
You may qualify if:
- Prescribed use of 1 or more antihypertensive medications
- English-speaking
- Residence in a disadvantaged neighborhood
You may not qualify if:
- History of malignant HTN
- Inability to comprehend the study protocol
- Institutionalized status
- Significant sensory or neurocognitive deficit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Chicago
Chicago, Illinois, 60637, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amber Johnson, MD
University of Chicago
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2023
First Posted
May 12, 2023
Study Start (Estimated)
September 1, 2027
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
November 1, 2028
Last Updated
June 6, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share
This award does not meet sponsor criteria for a Data Sharing Plan as the direct costs are \<$500,000/year.