Mobile Cued Adherence Therapy (mCAT) for Blood Pressure Medication

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

Interventions

BEHAVIORAL

Wellth App

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.

BEHAVIORAL

Action Planning

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").

BEHAVIORAL

Wellth + Cue

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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Wellth Inc.

  collaborator INDUSTRY

• Arizona State University

  collaborator OTHER

• Chad [email protected]

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-01

Primary Completion

2028-12-31

Completion

2029-03-30

Countries

• United States

Study Locations