Digital Health for Medication Adherence Among African Americans With Hypertension

NCT ID: NCT05009004

Last Updated: 2024-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-14
• Study Completion Date: 2023-10-30

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.

Conditions

Hypertension

Keywords

medication adherence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

text messages to support medication adherence

Intervention Type: BEHAVIORAL

text messages to support medication adherence

Interventions

text messages to support medication adherence

text messages to support medication adherence

Intervention Type: BEHAVIORAL

Eligibility Criteria

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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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Environment and Health Group, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Patricia Weitzman

Senior Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

patricia weitzman

Role: PRINCIPAL_INVESTIGATOR

founder

Locations

Environment and Health Group

Cambridge, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R43MD015969-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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