Mobile Health Coaching for High Blood Pressure

Recruiting at 1 trial location

Overseen by Amber Johnson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Chicago

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Amber Johnson, MD

Principal Investigator

University of Chicago

Eligibility Criteria

This trial is for adults over 18 with high blood pressure that isn't controlled, even though they're on medication. Participants must speak English and live in a disadvantaged neighborhood. It's not for those who can't understand the study, are institutionalized, have had malignant hypertension or serious sensory or brain function issues.

Inclusion Criteria

You live in a neighborhood that faces challenges or difficulties.

English-speaking

I am taking medication for high blood pressure.

Exclusion Criteria

Institutionalized status

Inability to comprehend the study protocol

I have had severe high blood pressure that caused organ damage.

Treatment Details

Interventions

• Enhanced Usual Care (Behavioral Intervention)
• mHealth Coaching Intervention (Behavioral Intervention)

Trial Overview The study is testing a new way to manage high blood pressure using mobile health coaching compared to enhanced usual care. The goal is to see if this approach works well and if people like it before moving on to a larger test.

Participant Groups

Group I: Behavioral mHealth Coaching Intervention Experimental Treatment 1 Intervention

Those 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.

Group II: Enhanced Usual Care Active Control 1 Intervention

The 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.

Enhanced Usual Care is already approved in China for the following indications:

Approved in China as Lactulose for:

• Hepatic encephalopathy
• Constipation

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+