Mobile Health Coaching for High Blood Pressure

Recruiting at 1 trial location

Overseen By Amber Johnson, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Must be taking: Antihypertensives

Disqualifiers: Malignant HTN, Sensory deficit, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

40 Participants Needed

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.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, since participants must be on at least one antihypertensive medication, it seems likely you will continue your current treatment.

What data supports the effectiveness of this treatment for high blood pressure?

Research shows that mobile health applications and health coaching can improve medication adherence and blood pressure control. For example, a study using a mobile app called Medisafe found that 64% of participants improved their blood pressure control, and another study showed that health coaching increased medication adherence and reduced blood pressure over time. ^{1 2 3 4 5}

Is mobile health coaching for high blood pressure safe for humans?

The available research suggests that mobile health applications, like Medisafe and the Personal Education Program, are generally safe for humans. These programs have been tested in adults with high blood pressure and have shown positive results in improving medication adherence and blood pressure control without reported safety concerns. ^{1 5 6 7 8}

How does the mHealth Coaching Intervention for high blood pressure differ from other treatments?

The mHealth Coaching Intervention is unique because it combines mobile health technology with personalized coaching to help manage high blood pressure, focusing on self-management and behavior change rather than just medication. This approach is designed to improve patient engagement and adherence to treatment plans, which can be particularly beneficial for young adults and underserved populations. ^{2 4 9 10 11}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

2 visits (in-person)

Baseline and Training

Participants receive a confirmatory interview, informed consent, and baseline device training via telephone

1 week

1 visit (virtual)

Intervention

Participants receive smartphones with preloaded applications and BP monitors; daily BP readings are encouraged and uploaded automatically

12 weeks

Ongoing virtual engagement

Follow-up

Participants are monitored for safety and effectiveness after intervention completion

4 weeks

1 visit (virtual)

Treatment Details

Interventions

• Enhanced Usual Care
• mHealth Coaching 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 United States, European Union, China for the following indications:

Approved in United States as Lactulose for:

• Hepatic encephalopathy
• Constipation

Approved in European Union as Lactulose for:

• Hepatic encephalopathy
• Constipation

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+

Findings from Research

A health-coaching intervention significantly improved medication adherence among 477 patients with hypertension, leading to an increase in adherence scores from 5.75 to 5.94 (P = .04).

The intervention also resulted in a notable decrease in diastolic blood pressure from 81.6 to 76.1 mm Hg (P < .001), with improvements in medication adherence being linked to these reductions in blood pressure over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a practice-based multicomponent intervention that includes health coaching on medication adherence and blood pressure control in rural primary care. Wu, JR., Cummings, DM., Li, Q., et al.[2021]

Pharmacist health coaching significantly improved medication management and exercise behaviors in 20 participants with poorly controlled hypertension, leading to a notable decrease in systolic blood pressure by 7.53 mmHg over four months.

Participants receiving health coaching showed better medication adherence, with scores on the Adherence to Refills and Medications Scale decreasing from 15.60 to 13.05, while the control group did not experience significant changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pharmacist health coaching trial evaluating behavioural changes in participants with poorly controlled hypertension. Singh, HK., Kennedy, GA., Stupans, I.[2022]

In a study involving 25 uninsured hypertensive patients, the use of trained student health coaches led to a significant increase in medication adherence and a notable reduction in systolic blood pressure by 11 mmHg.

Qualitative feedback indicated high patient satisfaction with the coaching intervention, suggesting that this model could be a feasible approach to improve blood pressure management in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approach to antihypertensive adherence: a feasibility study on the use of student health coaches for uninsured hypertensive adults. Leung, LB., Busch, AM., Nottage, SL., et al.[2021]

In a study involving 1372 participants with high blood pressure, automated SMS text message support led to a small but significant reduction in systolic blood pressure compared to usual care, with a mean change of -2.2 mm Hg for information-only messages.

Both information-only and interactive SMS messaging improved the odds of achieving blood pressure control (<140/90 mm Hg) compared to usual care, but the interactive approach did not provide additional benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Phone Text Messages to Support Treatment Adherence in Adults With High Blood Pressure (SMS-Text Adherence Support [StAR]): A Single-Blind, Randomized Trial. Bobrow, K., Farmer, AJ., Springer, D., et al.[2022]

The Smart Hypertension Control Study is a randomized controlled trial involving 350 adults with uncontrolled hypertension, aiming to assess the effectiveness of a smartphone application that provides personalized coaching for hypertension management alongside home blood pressure monitoring.

The primary outcome of the study is to evaluate changes in systolic blood pressure after six months, with additional outcomes focusing on medication adherence and self-management practices, which could enhance hypertension control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a randomized controlled trial comparing a mobile phone-based hypertension health coaching application to home blood pressure monitoring alone: The Smart Hypertension Control Study. Persell, SD., Karmali, KN., Stein, N., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Mobile Health Application and Hypertension Management in Rural, Middle-Aged Adults: A Quality Improvement Project. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The effect of a practice-based multicomponent intervention that includes health coaching on medication adherence and blood pressure control in rural primary care. [2021]

3. England pubmed.ncbi.nlm.nih.gov

A pharmacist health coaching trial evaluating behavioural changes in participants with poorly controlled hypertension. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Approach to antihypertensive adherence: a feasibility study on the use of student health coaches for uninsured hypertensive adults. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Mobile Phone Text Messages to Support Treatment Adherence in Adults With High Blood Pressure (SMS-Text Adherence Support [StAR]): A Single-Blind, Randomized Trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Beta testing of a network-based health literacy program tailored for older adults with hypertension. [2021]

7. New Zealand pubmed.ncbi.nlm.nih.gov

A pilot program at the worksite to reduce adverse self-medication behaviors. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Comparing the effectiveness of the BPMAP (Blood Pressure Management Application) and usual care in self-management of primary hypertension and adherence to treatment in patients aged 30-60 years: study protocol for a randomized controlled trial. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Design of a randomized controlled trial comparing a mobile phone-based hypertension health coaching application to home blood pressure monitoring alone: The Smart Hypertension Control Study. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Health coaching to improve hypertension treatment in a low-income, minority population. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

MyHEART: A Non Randomized Feasibility Study of a Young Adult Hypertension Intervention. [2023]