Habitual Hypertension Medication Adherence in Arizona

Not Applicable

Completed

• Conditions: Medication Adherence; Habits; Hypertension

• Registration Number: NCT05672797
• Lead Sponsor: Arizona State University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-12
• Study First Submitted: 2022-12-19
• Study First Submitted QC: 2023-01-03
• Study First Posted: 2023-01-05
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Medication adherence	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.

Secondary Outcome Measures

Name	Time	Method
Stress	Change from baseline to follow-up (Month 9)	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.
Healthcare utilization	Change from baseline to follow-up (Month 9)	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.
Perceived health competence	Change from baseline to follow-up (Month 9)	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.
Wellth app data	Three-month intervention period	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.
Self-reported habit strength	Change from baseline to follow-up (Month 9)	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.
Healthcare cost savings	Change from baseline to follow-up (Month 9)	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.
Health-related quality of life	Change from baseline to follow-up (Month 9)	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).
Intrinsic motivation	Change from baseline to follow-up (Month 9)	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.

Trial Locations

Locations (1)

Arizona State University; 🇺🇸 Phoenix, Arizona, United States