Mobile Cued Adherence Therapy (mCAT) for Blood Pressure Medication

Chad [e-mail]

Status: Enrolling

Conditions: Habits; Hypertension; Medication Adherence

Treatments: Behavioral: Wellth + Cue; Behavioral: Wellth App; Behavioral: Action Planning

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT06876233

R01HL171706 (U.S. NIH Grant/Contract)

STUDY00020282

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 3 patient groups

Control

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Wellth App

Wellth + Cue

Experimental group

Description:

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.

Treatment:

Behavioral: Action Planning

Behavioral: Wellth + Cue