Habitual Hypertension Medication Adherence in Arizona

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Wellth app

Habit training

About this trial

This is an interventional supportive care trial for Medication Adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arizona State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

Control

Wellth

Wellth + Habit Training

Arm Description

Participants in the control group will not receive additional adherence reminders or financial incentives during the 9-month study.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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).

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.

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.

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.

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.

Full Information

NCT ID

NCT05672797

First Posted

December 19, 2022

Last Updated

July 19, 2023

Sponsor

Arizona State University

Collaborators

Wellth Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05672797

Brief Title

Habitual Hypertension Medication Adherence in Arizona

Official Title

Habitual Hypertension Medication Adherence in Arizona

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 12, 2022 (Actual)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Arizona State University

Collaborators

Wellth Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Medication Adherence, Habits, Hypertension

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

Participant

Allocation

Randomized

Enrollment

225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

Participants in the control group will not receive additional adherence reminders or financial incentives during the 9-month study.

Arm Title

Wellth

Arm Type

Experimental

Arm Description

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.

Arm Title

Wellth + Habit Training

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Wellth app

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Habit training

Intervention Description

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).

Primary Outcome Measure Information:

Title

Medication adherence

Description

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.

Time Frame

Change from baseline to follow-up (Month 9)

Secondary Outcome Measure Information:

Title

Self-reported habit strength

Description

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.

Time Frame

Change from baseline to follow-up (Month 9)

Title

Healthcare utilization

Description

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.

Time Frame

Change from baseline to follow-up (Month 9)

Title

Healthcare cost savings

Description

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.

Time Frame

Change from baseline to follow-up (Month 9)

Title

Health-related quality of life

Description

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).

Time Frame

Change from baseline to follow-up (Month 9)

Title

Perceived health competence

Description

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.

Time Frame

Change from baseline to follow-up (Month 9)

Title

Intrinsic motivation

Description

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.

Time Frame

Change from baseline to follow-up (Month 9)

Title

Stress

Description

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.

Time Frame

Change from baseline to follow-up (Month 9)

Title

Wellth app data

Description

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.

Time Frame

Three-month intervention period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chad Stecher, PhD

Phone

602-496-0957

Email

chad.stecher@asu.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Sara Cloonan, MS

Email

sacloona@asu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chad Stecher, PhD

Organizational Affiliation

Arizona State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Arizona State University

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85004

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chad Stecher, PhD

Phone

602-496-0957

Email

chad.stecher@asu.edu

First Name & Middle Initial & Last Name & Degree

Chad Stecher, PhD

12. IPD Sharing Statement

Plan to Share IPD

No

IPD Sharing Plan Description

Individual participant data will not be shared with other researchers. Aggregated data will be available upon request.

Medication Adherence, Habits, Hypertension

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial