Mobile Cued Adherence Therapy (mCAT) for Blood Pressure Medication

NCT06876233 | Recruiting

• 2 other identifiers: STUDY00020282R01HL171706
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Medication Adherence; Hypertension; Habits

Keywords

habits; medication adherence; hypertension; blood pressure; mobile app

Outcome Measures

Primary Outcomes (2)

• Medication Adherence

  The investigators will use Medicaid's prescription data to construct the Primary Outcome of AH medication adherence using the date and supply of pills for each new prescription or refill to determine the number of days in a month a client had pills available. Since refills are often made before an existing prescription ends, the supply of new medications will be counted on days following the last available dose of the prior prescription. The number of days with available AH medication(s) will be divided by the total number of days in the same month to calculate the proportion of days covered (PDC), which will range from 0 and 1.

  24 months prior to the study through the 24-month study period

• Cardiovascular Health

  All participants will be asked to submit blood pressure readings for seven consecutive days after baseline activities, and be reminded via SMS and email to submit readings after the 4-month intervention and again after the month 8, 12, and 24 assessments. The investigators will calculate the Primary Outcome measure of blood pressure as participants' mean and coefficient of variation in systolic and diastolic blood pressure over the seven-day interval.

  Baseline, after the 4-month intervention, 8-month follow-up, 12-month follow-up, and 24-month follow-up

Secondary Outcomes (1)

• Healthcare Utilization and Costs

  24 months prior to the study through the 24-month study period

Other Outcomes (3)

• Self-Reported Habit Strength

  Baseline, after the 4-month intervention, 8-month follow-up, 12-month follow-up, and 24-month follow-up

• Wellth-measured Habit Strength

  Continuously during 24-month study period

• Present Bias

  Baseline, after the 4-month intervention, 8-month follow-up, 12-month follow-up, and 24-month follow-up

Study Arms (3)

Control

NO 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.

Wellth only

EXPERIMENTAL

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.

Behavioral: Wellth App

Wellth + Cue

EXPERIMENTAL

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.

Behavioral: Action Planning; Behavioral: Wellth + Cue

Interventions

Wellth + Cue BEHAVIORAL

Participants will be eligible to receive $30 at the end of four consecutive 30-day periods ($120 in total) if they submit daily evidence of their medication adherence habit using the Wellth app (i.e. one photo that provides evidence of pill-taking and one photo that provides evidence of their contextual cue, which participants will select and specify on their comprehension survey at the start of the study). Photos must be submitted within a 2-hour window around a specific time of day chosen by the participant and set at the start of each 30-day period. They will lose $2 (from their $30 total) for every day they miss a medication check-in (plus evidence of their contextual cue) within their pre-set 2-hour window with 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.

Wellth + Cue

Wellth App BEHAVIORAL

Participants will be eligible to receive $30 at the end of four consecutive 30-day periods ($120 in total) if they demonstrate complete medication adherence through the Wellth app (i.e. taking a daily picture of their pills in their hand and submitting it through the Wellth app). Photos must be submitted within a 2-hour window around a specific time of day chosen by the participant and set at the start of each 30-day period. They will lose $2 (from their $30 total) for every day they miss a medication check-in within their pre-set 2-hour window with 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.

Wellth only

Action Planning BEHAVIORAL

Participants will learn about habits and the importance of contextual cues for triggering their AH pill taking, and be asked to complete an electronic worksheet with a detailed description of their personalized contextual cue in terms of its: 1) location (e.g., where in the participant's house or office does this cue occur); 2) time of day; 3) preceding action (e.g., "I usually go to the bathroom before making coffee"); and 4) a visual cue (e.g., "my coffee cup will trigger pill taking").

Wellth + Cue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 6 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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Wellth Inc.: collaborator
• Arizona State University: collaborator
• Chad Stecher@asu.edu: lead

Study Sites (1)

Wellth Inc.

Los Angeles, California, 90292, United States

RECRUITING

MeSH Terms

Conditions

Medication Adherence; Hypertension; Habits

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Chad D Stecher, PhD

CONTACT

602-496-0957; chad.stecher@asu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 14, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 30, 2029
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)