Medication AdherencemCATNCT06876233
Mobile Cued Adherence Therapy (mCAT) for Blood Pressure Medication
A study testing Wellth App, Action Planning and Wellth + Cue in people with Medication Adherence and Hypertension, run by Chad Stecher@asu.edu at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence, Hypertension, Habits
- What is being tested?
- Wellth App, Action Planning and Wellth + Cue
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 30 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wellth Inc.
Los Angeles, California, 90292
Wellth Support Team, (844) 334-7360, help@wellthapp.com
About this study
Official title: Mobile Cued Adherence Therapy (mCAT): A Scalable Habit Formation Intervention to Improve Blood Pressure Medication Adherence Based on a Widely Used Smartphone App
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?
Read more
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
- Being tested
- Wellth App, Action Planning, Wellth + Cue
- Keywords
- habits, medication adherence, hypertension, blood pressure, mobile app
- Medical subject headings
- Medication Adherence, Hypertension, Habits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellth AppBehavioural
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.
Action PlanningBehavioural
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 + CueBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Action Planning; Behavioral: Wellth + Cue |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
The investigators will use Medicaid's encounters and reimbursement costs data to construct our Secondary Outcomes of healthcare utilization and costs. The investigators will generate separate monthly measures of the number of unique encounters, as well as the number of days in an emergency department, and inpatient and outpatient healthcare settings. Since a single encounter can be billed multiple times (thus appearing multiple times in the data) or last multiple days, the investigators will remove duplicate encounter claims based on the date of service, diagnostic codes, and procedure costs associated with each encounter. The investigators will separately measure the monthly AHCCCS reimbursement costs for all unique encounters in each healthcare setting.
Measured: 24 months prior to the study through the 24-month study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Sep 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chad Stecher@asu.edu
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Wellth Inc., Arizona State University
- Responsible party
- Sponsor-investigator, Chad Stecher@asu.edu, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876233
- Sponsor's protocol ID
- STUDY00020282
- Other IDs
- R01HL171706
- Acronym
- mCAT
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. Aggregated data will be available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Cued Adherence Therapy (mCAT): A Scalable Habit Formation Intervention to Improve Blood Pressure Medication Adherence Based on a Widely Used Smartphone App
- ClinicalTrials.gov ID
- NCT06876233
- Acronym / sponsor ID
- mCAT / STUDY00020282
- Conditions
- Medication Adherence, Hypertension, Habits
- Keywords
- habits, medication adherence, hypertension, blood pressure, mobile app
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Chad Stecher@asu.eduUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Wellth Inc., Arizona State University
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Wellth AppParticipants 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. |
| Wellth + Cue | Experimental | Behavioral: Action Planning, Behavioral: Wellth + CueParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wellth AppParticipants 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. | Behavioural | Wellth only |
| Action PlanningParticipants 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"). | Behavioural | Wellth + Cue |
| Wellth + CueParticipants 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. | Behavioural | Wellth + Cue |
Primary outcome
Medication Adherence
Time frame: 24 months prior to the study through the 24-month study period
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.
Cardiovascular Health
Time frame: Baseline, after the 4-month intervention, 8-month follow-up, 12-month follow-up, and 24-month follow-up
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.
1 secondary outcome
Healthcare Utilization and Costs
Time frame: 24 months prior to the study through the 24-month study period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. Aggregated data will be available upon request.
Related trials for Medication Adherence
Not yet recruiting
Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition
Hypertension, Diabetes Mellitus, Type 2
Not yet recruiting
A Nurse-Led Personalized Self-Management Counseling Intervention to Improve Medication Adherence and Glycemic Control in Adults With Type 2 Diabetes: A Randomized Controlled Trial
Medication Adherence, Glycemic Control for Diabetes Mellitus
Not yet recruiting
Assessing Psoriasis Treatment Outcomes
Psoriasis
Active, not recruiting
HERDA: Pharmacist-Led Culturally Adapted Intervention for Depression Medication Adherence
Depression
Not yet recruiting
Asthma Ctrl SMART Trial
Asthma in Children, Asthma Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wellth App, Action Planning and Wellth + Cue in people with Medication Adherence and Hypertension, run by Chad Stecher@asu.edu at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chad D Stecher, PhD (602-496-0957, chad.stecher@asu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence (time frame: 24 months prior to the study through the 24-month study period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.