Medication AdherenceNCT05672797
Habitual Hypertension Medication Adherence in Arizona
A study testing Wellth app and Habit training in people with Medication Adherence and Habits, run by Arizona State University at 1 site in United States.
Trial summary
This research will implement a novel habit formation intervention among people living with hypertension and an indication of medication non-adherence to help maintain high anti-hypertensive (AH) medication adherence by leveraging the power of routines and unconsciously triggered habitual behaviors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence, Habits, Hypertension
- What is being tested?
- Wellth app and Habit training
- 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
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2022to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Aged 18 years old 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 (i.e., already been prescribed antihypertensive medication for a minimum of 12 months at the time of study enrollment)
- Demonstrated antihypertensive medication nonadherence by having over 73 days without documented antihypertensive 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)
Who cannot join
- Less than 18 years old
- Does not have current hypertension diagnosis
- Unable to read/write/understand English
- Does not have daily access to a smartphone
- Not currently engaged in hypertension care
- Has not demonstrated antihypertensive medication nonadherence within the past 12 months
Trial locations and contacts
1 site in 1 country.
About this study
This research will implement a novel habit formation intervention among people living with hypertension and an indication of medication non-adherence to help maintain high anti-hypertensive (AH) medication adherence by leveraging the power of routines and unconsciously triggered habitual behaviors. The investigators will test whether high AH medication adherence can be maintained using contextually-cued medication adherence habits that mitigate the negative effects of declining motivation, forgetfulness, and the cognitive burden of performing repeated daily behaviors. The use of mHealth tools will help to make this a scalable and sustainable intervention approach for addressing an important healthcare issue in Arizona.
- Conditions
- Medication Adherence, Habits, Hypertension
- Being tested
- Wellth app, Habit training
- Medical subject headings
- Medication Adherence, Habits, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellth appOther
The Wellth app will be provided to treatment groups 1 and 2 for free and it is available for download through all common mobile app stores for both iOS and Android phones. The Wellth App is a private company that serves over five million clients that range from patients of healthcare providers and beneficiaries of various health insurance companies to employees of large corporations, where the Wellth App is offered as a behavioral tool for increasing meditation adherence among individuals who are managing chronic conditions through daily meditations, e.g. chronic obstructive pulmonary disease, asthma, high blood pressure, coronary artery disease, and HIV. The Wellth App has already been offered to some members of Arizona Complete Health, so both Wellth and Arizona Complete Health are familiar with implementing this program among this target population.
Habit trainingBehavioural
Participants in treatment groups 1 and 2 will be asked to identify an existing routine behavior that will act as a "cue" for their daily pill-taking behavior to. However, only participants in treatment group 2 will have to submit visual evidence of their cue to the Wellth app in addition to photos of their medication in order to receive credit for the medication check-in (i.e., financial incentives conditional on using their cue).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants in the control group will not receive additional adherence reminders or financial incentives during the 9-month study. |
| Wellth | Experimental | Participants will be eligible to receive $30 at the end of three consecutive 30-day periods ($90 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 4-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 4-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. Receives: Other: Wellth app |
| Wellth + Habit Training | Experimental | Participants will also be eligible for $30 at the end of three consecutive 30-day periods ($90 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). Similar to T1, participants will lose $2 (from their $30 total) for every day they miss a check-in with the Wellth app within a 4-hour window around the time of day of their choosing at the start of each 30-day period. Participants will not have to pay money, i.e. they lose $2 per missed check-in from the $30 of incentives until their incentives equal $0. Thus, participants will be ineligible for any financial incentives if they miss more than 15 days in a 30-day period, where this group's check-in includes one photo of pill-taking and one photo of their contextual cue. Receives: Other: Wellth app; Behavioral: Habit training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
Medication adherence will be assessed using Arizona Health Care Cost Containment System (AHCCCS) prescription drug claims over the duration of the nine month study. Prescription drug claims are submitted when an individual requests a refill of their prescription. Thus, prescription drug claims reflect whether or not an individual was taking their medication over a given time frame.
Measured: Change from baseline to follow-up (Month 9)
Secondary outcomes (8)
Self-reported habit strength
Self-reported habit strength will be assessed using the Self-Reported Behavioral Automaticity Index (SRBAI). Behavioral automaticity is a component of habit strength that reflects the degree to which a behavior is performed automatically with little cognitive effort. SRBAI scores can range from 4 to 20, with higher scores indicating greater behavioral automaticity.
Measured: Change from baseline to follow-up (Month 9)
Healthcare utilization
Healthcare utilization will be assessed using Arizona Health Care Cost Containment System (AHCCCS) encounters claims data. This data reflects the number of inpatient, outpatient, and emergency encounters an individual reports over the duration of the nine month study.
Measured: Change from baseline to follow-up (Month 9)
Healthcare cost savings
Healthcare cost savings will be assessed using Arizona Health Care Cost Containment System (AHCCCS) encounters claims data. This data reflects the total cost of inpatient, outpatient, and emergency encounters over the duration of the nine month study.
Measured: Change from baseline to follow-up (Month 9)
Health-related quality of life
Health-related quality of life will be assessed using the Health-Related Quality of Life (HRQoL) Scale. These questions ask about recent pain, depression, anxiety, sleeplessness, vitality, and the cause, duration, and severity of a current activity limitation an individual may have in his or her life. Higher scores indicate lower health-related quality of life.
The HRQoL Scale also calculates a Summary Index of Unhealthy Days. Unhealthy days are an estimate of the overall number of days during the previous 30 days when the respondent felt that either his or her physical or mental health was not good. Healthy days are the positive complementary form of unhealthy days. Healthy days estimates the number of recent days when a person's physical and mental health was good (or better).
Measured: Change from baseline to follow-up (Month 9)
Perceived health competence
Perceived health competence will be assessed using the Perceived Health Competence Scale (PHCS). The PHCS is a domain-specific measure of the degree to which an individual feels capable of effectively managing their own health outcomes. Scores range from 1 to 5, with higher scores indicating greater perceived health competence.
Measured: Change from baseline to follow-up (Month 9)
Intrinsic motivation
Intrinsic motivation will be assessed using the Intrinsic Motivation Inventory. The IMI is a self-report scale that measures the degree to which an individual is intrinsically motivated to perform a certain behavior. Scores range from 1 to 7, with higher scores indicating higher intrinsic motivation.
Measured: Change from baseline to follow-up (Month 9)
Stress
Stress will be assessed using the Perceived Stress Scale. The PSS measures how much perceived stress an individual has experienced within the last month. Scores range from 0 to 40 with higher scores indicating greater perceived stress.
Measured: Change from baseline to follow-up (Month 9)
Wellth app data
Wellth app data will be collected from participants enrolled in the treatment groups to determine if participants were taking their medication at or around the same time every day. Participants in both treatment groups will submit photos of them taking their medication using the app. Participants in the Wellth + Habit Training group will also submit a photo of the stimuli they are using to cue their pill-taking habit.
Measured: Three-month intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start12 Dec 2022
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
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.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Wellth Inc.
- Responsible party
- Sponsor
- Investigators
- Chad Stecher, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672797
- Sponsor's protocol ID
- STUDY00017024
- Status last verified
- Jul 2024
- First submitted
- 19 Dec 2022
- Last updated
- 2 Aug 2024
- 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 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Habitual Hypertension Medication Adherence in Arizona
- ClinicalTrials.gov ID
- NCT05672797
- Acronym / sponsor ID
- STUDY00017024
- Conditions
- Medication Adherence, Habits, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Wellth Inc.
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 5 Jan 2023 (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.
This research will implement a novel habit formation intervention among people living with hypertension and an indication of medication non-adherence to help maintain high anti-hypertensive (AH) medication adherence by leveraging the power of routines and unconsciously triggered habitual behaviors. The investigators will test whether high AH medication adherence can be maintained using contextually-cued medication adherence habits that mitigate the negative effects of declining motivation, forgetfulness, and the cognitive burden of performing repeated daily behaviors. The use of mHealth tools will help to make this a scalable and sustainable intervention approach for addressing an important healthcare issue in Arizona.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in the control group will not receive additional adherence reminders or financial incentives during the 9-month study. |
| Wellth | Experimental | Other: Wellth appParticipants will be eligible to receive $30 at the end of three consecutive 30-day periods ($90 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 4-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 4-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 + Habit Training | Experimental | Other: Wellth app, Behavioral: Habit trainingParticipants will also be eligible for $30 at the end of three consecutive 30-day periods ($90 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). Similar to T1, participants will lose $2 (from their $30 total) for every day they miss a check-in with the Wellth app within a 4-hour window around the time of day of their choosing at the start of each 30-day period. Participants will not have to pay money, i.e. they lose $2 per missed check-in from the $30 of incentives until their incentives equal $0. Thus, participants will be ineligible for any financial incentives if they miss more than 15 days in a 30-day period, where this group's check-in includes one photo of pill-taking and one photo of their contextual cue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years old 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 (i.e., already been prescribed antihypertensive medication for a minimum of 12 months at the time of study enrollment)
Key exclusion criteria (6 listed)
- Less than 18 years old
- Does not have current hypertension diagnosis
- Unable to read/write/understand English
- Does not have daily access to a smartphone
- Not currently engaged in hypertension care
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 appThe Wellth app will be provided to treatment groups 1 and 2 for free and it is available for download through all common mobile app stores for both iOS and Android phones. The Wellth App is a private company that serves over five million clients that range from patients of healthcare providers and beneficiaries of various health insurance companies to employees of large corporations, where the Wellth App is offered as a behavioral tool for increasing meditation adherence among individuals who are managing chronic conditions through daily meditations, e.g. chronic obstructive pulmonary disease, asthma, high blood pressure, coronary artery disease, and HIV. The Wellth App has already been offered to some members of Arizona Complete Health, so both Wellth and Arizona Complete Health are familiar with implementing this program among this target population. | Other | Wellth, Wellth + Habit Training |
| Habit trainingParticipants in treatment groups 1 and 2 will be asked to identify an existing routine behavior that will act as a "cue" for their daily pill-taking behavior to. However, only participants in treatment group 2 will have to submit visual evidence of their cue to the Wellth app in addition to photos of their medication in order to receive credit for the medication check-in (i.e., financial incentives conditional on using their cue). | Behavioural | Wellth + Habit Training |
Primary outcome
Medication adherence
Time frame: Change from baseline to follow-up (Month 9)
Medication adherence will be assessed using Arizona Health Care Cost Containment System (AHCCCS) prescription drug claims over the duration of the nine month study. Prescription drug claims are submitted when an individual requests a refill of their prescription. Thus, prescription drug claims reflect whether or not an individual was taking their medication over a given time frame.
8 secondary outcomes
Self-reported habit strength
Time frame: Change from baseline to follow-up (Month 9)
Healthcare utilization
Time frame: Change from baseline to follow-up (Month 9)
Healthcare cost savings
Time frame: Change from baseline to follow-up (Month 9)
Health-related quality of life
Time frame: Change from baseline to follow-up (Month 9)
Perceived health competence
Time frame: Change from baseline to follow-up (Month 9)
Intrinsic motivation
Time frame: Change from baseline to follow-up (Month 9)
Stress
Time frame: Change from baseline to follow-up (Month 9)
Wellth app data
Time frame: Three-month intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. Aggregated data will be available upon request.
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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. This study is not recruiting at the moment.
Chad Stecher, PhD principal investigator
Arizona State University
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 and Habit training in people with Medication Adherence and Habits, run by Arizona State University 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?
The sponsor lists 6 inclusion and 6 exclusion criteria. 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: finished, as of the sponsor's last update on 2 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (time frame: Change from baseline to follow-up (Month 9)). 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 2 Aug 2024.