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Digital Health for Medication Adherence Among African Americans With Hypertension

Digital Health for Medication Adherence Among African Americans With Hypertension

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05009004
Enrollment
22
Registered
2021-08-17
Start date
2022-10-14
Completion date
2023-10-30
Last updated
2024-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

medication adherence

Brief summary

The proposed Phase 1 project aims to develop and test Memento.HTN, an individually-tailored, culturally sensitive digital health intervention comprised of a provider platform and linked patient SMS (short message service) text system to promote medication adherence among African Americans with hypertension (HTN), a group that suffers from disproportionate HTN morbidity and mortality. Memento.HTN overcomes access barriers on the part of patients and adherence support implementation barriers on the part of healthcare teams and systems. Memento.HTN is innovative in three key ways: 1) it is the first-ever linked digital provider platform and patient SMS text system for HTN medication adherence; 2) it is culturally-tailored for African Americans with HTN; and 3) it has unique monitoring functionality allowing providers to monitor individual patient adherence, support 'new start' patients, and track group adherence rates by drug class, pill format, and patient demographics.

Detailed description

Abstract: Under the leadership of Patricia Weitzman, PhD, a multicultural, multidisciplinary team of clinicians and researchers will collaborate to develop, formatively test, and evaluate the short-effectiveness of a digital provider platform, called Memento.HTN, that is integrated with a patient SMS text system, and designed to support medication adherence by African Americans with hypertension (HTN). HTN is more common and more destructive for African Americans than for any other ethnic group. More than half of African American adults, about 15 million people, have HTN. Furthermore, African Americans are 4 times less likely to adhere to HTN medications compared to their white counterparts. Tailored approaches to reduce the racial gap in HTN morbidity and mortality, particularly those that support medication adherence, are needed in primary care. Such approaches must overcome barriers due to cost or geographic distance that can prevent African American patients from accessing adherence support. These approaches must also overcome barriers to the delivery of adherence support that stem from healthcare systems themselves. Importantly, HTN is one of most common co-morbidities in Covid19 hospitalizations, particularly for African Americans (CDC 2020). Moreover, media coverage of a possible link between certain HTN meds, called RAAS inhibitors, and severe Covid19 outcomes may have alarmed HTN patients about the safety of their meds. As a result, the ACC (March, 2020) promptly issued guidelines recommending all patients adhere to HTN meds during the pandemic unless advised by their physicians, as there is no evidence of a link between HTN drugs and Covid19 severity. Thus, in the time of Covid19, supporting medication adherence of African Americans with HTN is extremely urgent. Memento.HTN is innovative in three key ways: 1) To our knowledge, it is the first-ever linked digital provider platform and patient SMS text system for HTN medication adherence. 2) It is culturally-tailored for African Americans with HTN. 3) It has unique monitoring functionality allowing providers to monitor individual patient adherence; support 'new start' patients, who are at increased risk for non-adherence; and track group adherence rates by drug class, pill format, and patient demographics, which have never been included in any digital med adherence intervention. Thus, the Memento.HTN system greatly simplifies and facilitates provider delivery of adherence support to patients, while enhancing their clinical therapeutics. The provider platform sends patients interactive SMS-text pill reminders plus culturally-sensitive motivational, educational, spiritual/stress-supportive, and customizable texts, along with texts targeting intentional non-adherence and Covid19-related concerns. Texts go directly to patient cellphones (no mobile app needed), making the intervention accessible to patients who do not possess smartphones. Importantly, Memento allows 2-way texting communication between providers and patients, and automatically alerts providers when a patient has a clinically-significant pill lapse. Memento has significant commercial potential, as EHG has already developed plans for multiple digital adherence interventions that will be marketed together to clinics serving large numbers of at-risk patients. This B2B business model can generate large increases in revenues for customers, making our products attractive from both a financial and health perspective.

Interventions

BEHAVIORALtext messages to support medication adherence

text messages to support medication adherence

Sponsors

Environment and Health Group, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Feasibility study involving pre-post evaluation of a digital health intervention on hypertension medication adherence.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Self-identify as African American, age 18 & older, diagnosed with hypertension and on meds for it, own a cellphone (basic or smart) -

Exclusion criteria

Participation in other clinical research; undergoing cancer treatment; pregnancy; end stage renal disease \-

Design outcomes

Primary

MeasureTime frameDescription
Wilson Self Report Medication Adherence Scale6 weeksThe self-reported medication adherence scare, developed by Wilson et al. (2016), is designed to assess self reported mediation adherence. The total scale ranges from a minimum score = 0 to a maximum score = 299.9. Higher score means better medication adherence.
Hypertension Medication Adherence Self-efficacy Scale (MASES)6 weeksThe Hypertension MASES scale measures self efficacy for adhering hypertension medications. The scale ranges from a minimum total score = 0 to a maximum total score = 13. Higher score means greater medication adherence self efficacy.

Secondary

MeasureTime frameDescription
Perceived Stress Scale6 weeksThe perceived stress burden scale, Cohen (1983) measures perceived stress levels. The scale ranges from a minimum total score = 0 to a maximum total score = 40. Higher total scores mean higher perceived stress.

Countries

United States

Participant flow

Participants by arm

ArmCount
Digital Health Intervention Using Text Messages to Support Medication Adherence
In this one-arm, pre-post evaluation, all participants will receive the digital health intervention consisting of daily text messages to support medication adherence. text messages to support medication adherence: text messages to support medication adherence
22
Total22

Baseline characteristics

CharacteristicDigital Health Intervention Using Text Messages to Support Medication Adherence
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
3 Participants
Age, Categorical
Between 18 and 65 years
19 Participants
Age, Continuous50.36 years
STANDARD_DEVIATION 10.73
Race/Ethnicity, Customized
African American
22 Participants
Region of Enrollment
United States
22 participants
Self report medication adherence87.56 units on a scale
STANDARD_DEVIATION 0.24
Sex: Female, Male
Female
16 Participants
Sex: Female, Male
Male
6 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 22
other
Total, other adverse events
0 / 22
serious
Total, serious adverse events
0 / 22

Outcome results

Primary

Hypertension Medication Adherence Self-efficacy Scale (MASES)

The Hypertension MASES scale measures self efficacy for adhering hypertension medications. The scale ranges from a minimum total score = 0 to a maximum total score = 13. Higher score means greater medication adherence self efficacy.

Time frame: 6 weeks

ArmMeasureValue (MEAN)Dispersion
Digital Health Intervention Using Text Messages to Support Medication AdherenceHypertension Medication Adherence Self-efficacy Scale (MASES)5.95 score on a scaleStandard Deviation 4.66
Primary

Wilson Self Report Medication Adherence Scale

The self-reported medication adherence scare, developed by Wilson et al. (2016), is designed to assess self reported mediation adherence. The total scale ranges from a minimum score = 0 to a maximum score = 299.9. Higher score means better medication adherence.

Time frame: 6 weeks

ArmMeasureValue (MEAN)Dispersion
Digital Health Intervention Using Text Messages to Support Medication AdherenceWilson Self Report Medication Adherence Scale91.86 units on a scaleStandard Deviation 9.68
Secondary

Perceived Stress Scale

The perceived stress burden scale, Cohen (1983) measures perceived stress levels. The scale ranges from a minimum total score = 0 to a maximum total score = 40. Higher total scores mean higher perceived stress.

Time frame: 6 weeks

ArmMeasureValue (MEAN)Dispersion
Digital Health Intervention Using Text Messages to Support Medication AdherencePerceived Stress Scale15.05 score on a scaleStandard Deviation 5.2

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026