Habitual Hypertension Medication Adherence in Arizona

NCT05672797 | Completed

• 1 other identifier: STUDY00017024
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Medication Adherence; Habits; Hypertension

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline to follow-up (Month 9)

Secondary Outcomes (8)

• Self-reported habit strength

  Change from baseline to follow-up (Month 9)

• Healthcare utilization

  Change from baseline to follow-up (Month 9)

• Healthcare cost savings

  Change from baseline to follow-up (Month 9)

• Health-related quality of life

  Change from baseline to follow-up (Month 9)

• Perceived health competence

  Change from baseline to follow-up (Month 9)

Study Arms (3)

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.

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.

Other: Wellth app; Behavioral: Habit training

Interventions

Wellth app OTHER

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.

Wellth; Wellth + Habit Training

Habit training BEHAVIORAL

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).

Wellth + Habit Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead
• Wellth Inc.: collaborator

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Medication Adherence; Habits; Hypertension

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chad Stecher, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 5, 2023
• Study Start: December 12, 2022
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)