Mobile Health Coaching for High Blood Pressure

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for managing high blood pressure through mobile health coaching. The study compares two groups: one receives enhanced usual care with some tech tools, while the other uses a special app providing daily reminders to check blood pressure. It targets individuals who take blood pressure medication, speak English, and live in areas with limited healthcare access. The goal is to determine if this approach is user-friendly and effective, potentially leading to larger studies in the future. As an unphased trial, it offers a unique opportunity to contribute to innovative healthcare solutions and improve future access to care.

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 prior data suggests that this mHealth coaching intervention is safe for managing high blood pressure?

Research has shown that using mobile health (mHealth) tools to manage high blood pressure is both popular and effective. Studies have found that these tools help people control their blood pressure and are easy to use. No major reports of negative effects have emerged, indicating that mHealth coaching is safe.

In one study, participants using a mobile health program improved their habits for managing high blood pressure. Another study found that users of mHealth tools gained a better understanding of how to manage their blood pressure. These results suggest that this approach is safe and well-accepted by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mHealth Coaching Intervention for high blood pressure because it offers a unique blend of technology and health management. Unlike traditional treatments that primarily rely on medication, this intervention uses a smartphone-based program to provide reminders and support for daily blood pressure monitoring. This tech-driven approach not only encourages more consistent self-monitoring but also facilitates real-time data sharing with healthcare providers, potentially leading to better personalized care. By integrating modern technology with health coaching, the mHealth intervention aims to empower patients with tools for more proactive blood pressure management.

What evidence suggests that this trial's treatments could be effective for high blood pressure?

Research has shown that mobile health (mHealth) coaching can effectively manage high blood pressure. In this trial, participants will join either the Enhanced Usual Care group or the Behavioral mHealth Coaching Intervention group. One study found that mHealth tools led to a noticeable drop in the systolic blood pressure by about 3.85 points. Another study discovered that using a wearable blood pressure monitor with an app could lower this number by 8.52 points. These tools also seem to enhance individuals' understanding and confidence in managing their high blood pressure. Overall, mHealth coaching appears promising for helping people control their blood pressure. ^{1 2 5 6 7}

Who Is on the Research Team?

Amber Johnson, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12035198/

Using mHealth to support health coaching for patients with ...

Participants' mean score for knowledge of hypertension showed a nonsignificant increase from 70.8% (SD = 11.1) to 74.7% (SD = 11.3) during the ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10014612/

Effectiveness of a mHealth intervention on hypertension ...

The results of this randomized control trial showed that the wearable BP wristband and app-based management could decreased SBP by 8.52 (19.73) ...

3.

formative.jmir.org

formative.jmir.org/2020/5/e13989/

A Mobile Health Coaching Intervention for Controlling ...

In this pilot study, we found that an interactive mobile app (DASH Mobile) to promote healthy behaviors that reduce hypertension was feasible ...

4.

journals.sagepub.com

journals.sagepub.com/doi/10.1177/20552076231215904

Investigating the effect of an mHealth coaching intervention ...

A mobile health coaching intervention may help participants improve beliefs regarding hypertension self-management.

5.

ahajournals.org

ahajournals.org/doi/10.1161/HYPERTENSIONAHA.119.13273

Interactive Mobile Health Intervention and Blood Pressure ...

Compared with the control group, mhealth intervention was associated with significant changes in systolic BP and diastolic BP of −3.85 mm Hg; 95 ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05546931

Mobile Health Program for Rural Hypertension

The 6-month intervention provides a personalized curriculum to promote HBPM; medication adherence; HTN education; non-pharmacologic strategies for HTN ...

7.

frontiersin.org

frontiersin.org/journals/public-health/articles/10.3389/fpubh.2023.1049396/full

Effectiveness of a mHealth intervention on hypertension ...

After 12 weeks of follow-up, the mean (SD) hypertension compliance increased by 7.35 (7.31) in the intervention group and by 3.01 (4.92) in the ...