Mobile Cued Adherence Therapy for Hypertension

(mCAT Trial)

Overseen By Chad D Stecher, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Chad [e-mail]

Must be taking: Antihypertensives

Disqualifiers: Non-hypertension, No smartphone, others

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a mobile app can assist individuals in adhering to their blood pressure medication and reducing healthcare costs. Researchers aim to determine if daily reminders and financial rewards encourage medication adherence and help maintain blood pressure levels. The trial compares three groups: one receiving only financial incentives, another receiving incentives and planning prompts, and a control group receiving basic reminders. This trial suits individuals who have had high blood pressure for at least a year, use a smartphone daily, and frequently forget to take their medication. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance medication adherence and lower healthcare costs.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, since the study focuses on improving adherence to your existing hypertension medication, it is likely that you will continue taking them.

What prior data suggests that this mobile health-based intervention is safe for increasing medication adherence?

Research has shown that the Wellth mobile app, used in the trial, is safe for participants. Studies have found that the app helps people adhere to their medication plans by providing financial rewards and reminders. Users have managed conditions like high blood pressure without major problems.

The Wellth app with the Cue action plan is also safe. It combines the app's features with a plan that sets specific times for medication intake. This method encourages regular medication use and has not caused any significant safety issues so far.

Overall, using mobile apps like Wellth to manage medication is well-accepted. These apps aim to improve medication adherence without causing harm, making them a safe choice for those seeking better management of their medication routines. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mobile Cued Adherence Therapy (mCAT) for hypertension because it leverages technology in a way that could transform patient adherence. Unlike traditional hypertension treatments that rely on patients remembering to take their medication, mCAT uses the Wellth app to provide daily reminders and financial incentives, encouraging patients to submit photo evidence of their pill-taking. This approach not only engages patients more actively in their treatment but also uses real-time feedback and rewards, which could significantly improve adherence rates. The addition of a personalized action plan in the Wellth + Cue group adds an extra layer of motivation and customization, potentially leading to even better outcomes.

What evidence suggests that this trial's treatments could be effective for hypertension?

Research has shown that the Wellth app, which offers monetary rewards for medication adherence, can improve how regularly people take their medicine. In this trial, participants in the "Wellth only" group will use the app to receive daily financial incentives for providing photo evidence of their pill-taking. Studies have found that health apps like Wellth can help control blood pressure and improve quality of life. The app's reminders and rewards assist users in remembering to take their blood pressure medicine regularly. Participants in the "Wellth + Cue" group will also use the app, with added planning strategies to link pill-taking to daily habits, potentially enhancing adherence. These methods aim to help people with high blood pressure manage their condition better. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for people living with high blood pressure who often forget to take their anti-hypertensive medication. Participants should be willing to complete online surveys, submit blood pressure readings, and provide photo evidence of taking their pills if they're in the intervention groups.

Inclusion Criteria

Able to read/write/understand English

Have daily access to a smartphone

I have been diagnosed with high blood pressure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive daily financial incentives for providing photo evidence of their pill taking using the Wellth app for 4 months

4 months

Daily check-ins via app

Follow-up

Participants complete online surveys and submit blood pressure readings at multiple timepoints to monitor adherence and health outcomes

24 months

5 online surveys, blood pressure readings at each survey timepoint

Interviews

Highest- and lowest-performing participants in each intervention group complete a 30-minute interview to identify factors contributing to intervention success or failure

What Are the Treatments Tested in This Trial?

Interventions

• Mobile Cued Adherence Therapy (mCAT)

Trial Overview The study tests if a mobile app that gives daily incentives can help people remember to take their blood pressure medicine. It also looks at whether adding a plan like 'take meds after morning coffee' improves adherence. There are three groups: one with just incentives, one with incentives plus planning, and a control group.

How Is the Trial Designed?

Group I: Wellth only Experimental Treatment 1 Intervention

Participants in the Wellth only group will receive daily financial incentives during the 4-month intervention for providing photo evidence of their pill taking using the mobile app Wellth (i.e. taking a daily picture of their pills in their hand and submitting it through the Wellth app). The Wellth app will also provide reminders at the end of the day if participants have not yet completed their daily check-in. Participants will also receive SMS reminders of each assessment point and monthly two-way SMS messages to provide AH pill-taking tips and to ask if participants are feeling dizziness or other symptoms of low blood pressure.

Group II: Wellth + Cue Experimental Treatment 2 Interventions

Participants in the Wellth+Cue group will receive daily financial incentives during the 4-month intervention for providing photo evidence of their pill taking using the mobile app Wellth (i.e. taking a daily picture of their pills in their hand and submitting it through the Wellth app), conditional on using their action plan. The Wellth app will also provide reminders at the end of the day if participants have not yet completed their daily check-in. Participants will also receive SMS reminders of each assessment point and monthly two-way SMS messages to provide AH pill-taking tips and to ask if participants are feeling dizziness or other symptoms of low blood pressure.

Group III: Control Active Control 1 Intervention

Control participants will receive SMS reminders of each assessment point and monthly two-way SMS messages to provide AH pill-taking tips and to ask if participants are feeling dizziness or other symptoms of low blood pressure. Participants in the control group will not receive additional adherence reminders, financial incentives, or the Wellth app during the 24-month study.

Who Is Running the Clinical Trial?

Chad [e-mail]

Lead Sponsor

Trials

1

Recruited

600+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Wellth Inc.

Industry Sponsor

Trials

7

Recruited

1,100+

Arizona State University

Collaborator

Trials

311

Recruited

109,000+

Published Research Related to This Trial

The pilot study involving 29 women with metastatic breast cancer demonstrated that the CONnected CUstomized Treatment Platform effectively maintained a high palbociclib adherence rate of 95.8%, indicating its potential for improving medication compliance.

Despite the high adherence rate, participants reported no significant changes in symptom burden or quality of life over three months, suggesting that while the intervention is feasible, further improvements in usability are needed to enhance overall patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving palbociclib adherence among women with metastatic breast cancer using a CONnected CUstomized Treatment Platform: A pilot study. Sadigh, G., Meisel, JL., Byers, K., et al.[2023]

Long-term adherence to antihypertensive medications is generally poor, highlighting the need for new strategies to improve patient compliance with prescribed drug regimens.

Behavior change principles can effectively enhance medication adherence by tailoring interventions to a patient's stage of change, with techniques like rewards and reminders being most effective for those ready to change, while earlier-stage patients benefit from awareness-raising interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior-changing methods for improving adherence to medication. Willey, C.[2019]

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]

Mobile phone-based self-management interventions significantly reduced diastolic blood pressure in patients with coronary heart disease, with a mean difference of -1.99 mmHg based on 11 meta-analysed trials.

While these interventions showed promise for improving self-management, they did not have a statistically significant effect on medication adherence or systolic blood pressure, indicating the need for better-designed studies to confirm their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mobile phone-based self-management interventions for medication adherence and change in blood pressure in patients with coronary heart disease: A systematic review and meta-analysis. Sua, YS., Jiang, Y., Thompson, DR., et al.[2021]

The study involving 38 participants showed that combining psychoeducation with the automated text messaging intervention (iTAB-CV) significantly improved adherence to antihypertensive medications, reducing nonadherence from 43% to 21% over 12 weeks.

Participants also experienced a significant decrease in systolic blood pressure, from an average of 144.8 mmHg to 136.0 mmHg, indicating that the intervention not only improved adherence but also had a positive impact on health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Psychoeducation and a Text Messaging Adherence Intervention Among Individuals With Hypertension and Bipolar Disorder. Levin, JB., Sajatovic, M., Rahman, M., et al.[2020]

Citations

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