Digital Health for Medication Adherence Among African Americans With Hypertension

Hypertension Clinical Trial

Official title:

Digital Health for Medication Adherence Among African Americans With Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05009004
• Other study ID #: 1R43MD015969-01A1
• Status: Completed
• Phase: Phase 1
• Start date: May 1, 2021
• Est. completion date: October 30, 2023

Study information

• Verified date: February 2024
• Source: Environment and Health Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed Phase 1 project aims to develop and test Memento.HTN, an individually-tailored, culturallysensitive digital health intervention comprised of a provider platform and linked patient SMS 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 30, 2023
• Est. primary completion date: June 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• text messages to support medication adherence
text messages to support medication adherence

Locations

Country	Name	City	State
United States	Environment and Health Group	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Environment and Health Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to Refills and Medication Scale ARMS	self-report measure	6 weeks
Primary	HTN med adherence self-efficacy scale (MASES)	adherence self-efficacy	6 weeks
Secondary	Perceived Stress Scale	perceived stress burden	6 weeks