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

600 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to determine the effectiveness of a novel mobile health-based habit formation intervention for increasing and maintaining adherence to anti-hypertensive (AH) medication among people living with hypertension and indicate medication nonadherence. The main questions it aims to answer are: * Can daily incentives for AH pill taking increase and maintain AH medication adherence, control blood pressure, and reduce healthcare utilization and costs? * Can daily incentives for AH pill taking, combined with action planning (e.g., "After I drink my morning coffee, I will take my medication.") increase and maintain medication adherence, control blood pressure, and reduce healthcare utilization and costs? * What aspects of daily incentives and/or action planning do participants find most helpful or effective for AH medication adherence? * What barriers exist for participants who receive daily incentives and/or action planning? Researchers will compare three study groups: those who only receive daily incentives for the AH pill taking, those who receive daily incentives for AH pill taking combined with action planning, and a control group (who do not receive daily incentives for AH pill taking or action planning). By comparing these three groups, the researchers will be able to determine the effectiveness of the daily incentives with or without action planning for promoting long-term AH medication adherence, reduce healthcare costs, and improve blood pressure. Participants will: * Complete 5 online surveys over the course of 2 years (baseline, month 4, month 8, month 12, month 24). * Submit blood pressure reading for 7 consecutive days after each survey timepoint. * Submit photo evidence of their AH pill taking for 4 months (intervention groups only). The highest- and lowest-performing participants in each intervention group will also be invited to complete a 30-minute interview to identify additional factors that contributed to either successful or unsuccessful completion of the intervention.

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 data supports the effectiveness of the treatment Mobile Cued Adherence Therapy (mCAT) for hypertension?

Research shows that behavior-changing methods, like reminders and self-monitoring, can improve how well people stick to their medication routines, which is crucial for managing high blood pressure. Smartphone apps, similar to mCAT, have been found to help people manage their medication better by providing reminders and support. ^{1 2 3 4 5}

Is Mobile Cued Adherence Therapy (mCAT) safe for humans?

The research articles provided do not contain specific safety data for Mobile Cued Adherence Therapy (mCAT) or similar interventions. However, related studies on mobile phone text messaging and educational programs for medication adherence in hypertension suggest these approaches are generally well-received and improve adherence without reported safety concerns. ^{2 6 7 8 9}

How is the Mobile Cued Adherence Therapy (mCAT) treatment different from other treatments for hypertension?

Mobile Cued Adherence Therapy (mCAT) is unique because it uses mobile technology to improve medication adherence by integrating reminders and self-management support into patients' daily routines, which can help ensure they take their medication as prescribed. This approach is different from traditional treatments that rely solely on medication without additional adherence support. ^{2 3 10 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

References

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

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

2. Switzerland pubmed.ncbi.nlm.nih.gov

Adherence to pharmacologic management of hypertension. [2020]

3. Canada pubmed.ncbi.nlm.nih.gov

Patients' Experiences of Using Smartphone Apps to Support Self-Management and Improve Medication Adherence in Hypertension: Qualitative Study. [2021]

4. 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]

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

Adherence in Hypertension. [2020]

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

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

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

Outcomes of Psychoeducation and a Text Messaging Adherence Intervention Among Individuals With Hypertension and Bipolar Disorder. [2020]

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

Mobile phone text messaging improves antihypertensive drug adherence in the community. [2021]

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

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

10. England 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. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Efficacy of a text messaging (SMS) based intervention for adults with hypertension: protocol for the StAR (SMS Text-message Adherence suppoRt trial) randomised controlled trial. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Improving palbociclib adherence among women with metastatic breast cancer using a CONnected CUstomized Treatment Platform: A pilot study. [2023]