Clinical trial NCT05672797: Habitual Hypertension Medication Adherence in Arizona
Official title: Habitual Hypertension Medication Adherence in Arizona
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Habits
Hypertension
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Wellth Inc.
First posted: 2023-01-05
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Medication adherence
timeFrame: Change from baseline to follow-up (Month 9)
Secondary outcomes:
measure: Self-reported habit strength
timeFrame: Change from baseline to follow-up (Month 9)
measure: Healthcare utilization
timeFrame: Change from baseline to follow-up (Month 9)
measure: Healthcare cost savings
timeFrame: Change from baseline to follow-up (Month 9)
measure: Health-related quality of life
timeFrame: Change from baseline to follow-up (Month 9)
measure: Perceived health competence
timeFrame: Change from baseline to follow-up (Month 9)
measure: Intrinsic motivation
timeFrame: Change from baseline to follow-up (Month 9)
measure: Stress
timeFrame: Change from baseline to follow-up (Month 9)
measure: Wellth app data
timeFrame: Three-month intervention period
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Arizona State University
name: Chad Stecher, PhD
role: PRINCIPAL_INVESTIGATOR
References: