Mobile Cued Adherence Therapy (mCAT): A Scalable Habit Formation Intervention to Improve Blood Pressure Medication Adherence Based on a Widely Used Smartphone App

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Eligibility Criteria:

• Aged 18 years or older

• Currently diagnosed with hypertension (either stage I or stage II hypertension)

• Able to read/write/understand English

• Have daily access to a smartphone

• Engaged in hypertension care: Already been prescribed hypertension medication for a minimum of 12 months at the time of study enrollment

• Demonstrated AH medication nonadherence by having over 73 days without documented AH medication prescription coverage (observable in Arizona Health Care Cost Containment System (AHCCCS) prescription drugs claims) in the past 12 months (i.e. \<80% mean adherence)

Locations
United States
California
Wellth Inc.
RECRUITING
Los Angeles
Contact Information
Primary
Chad D Stecher, PhD
chad.stecher@asu.edu
602-496-0957
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2029-03-30
Participants
Target number of participants: 600
Treatments
No_intervention: Control
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.
Experimental: Wellth only
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.
Experimental: Wellth + Cue
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.
Related Therapeutic Areas
Sponsors
Collaborators: Arizona State University, Wellth Inc., National Heart, Lung, and Blood Institute (NHLBI)
Leads: Chad Stecher@asu.edu

This content was sourced from clinicaltrials.gov