Digital Health for Medication Adherence Among African Americans With Hypertension
Primary Purpose
Hypertension
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
text messages to support medication adherence
Sponsored by

About this trial
This is an interventional supportive care trial for Hypertension focused on measuring medication adherence
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
-
Sites / Locations
- Environment and Health Group
Outcomes
Primary Outcome Measures
Adherence to Refills and Medication Scale ARMS
self-report measure
HTN med adherence self-efficacy scale (MASES)
adherence self-efficacy
Secondary Outcome Measures
Perceived Stress Scale
perceived stress burden
Full Information
NCT ID
NCT05009004
First Posted
August 10, 2021
Last Updated
July 7, 2023
Sponsor
Environment and Health Group, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05009004
Brief Title
Digital Health for Medication Adherence Among African Americans With Hypertension
Official Title
Digital Health for Medication Adherence Among African Americans With Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
June 23, 2023 (Actual)
Study Completion Date
October 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Environment and Health Group, 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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
medication adherence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Pre-post evaluation study of the impact of the digital health intervention on hypertension medication adherence.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
text messages to support medication adherence
Intervention Description
text messages to support medication adherence
Primary Outcome Measure Information:
Title
Adherence to Refills and Medication Scale ARMS
Description
self-report measure
Time Frame
6 weeks
Title
HTN med adherence self-efficacy scale (MASES)
Description
adherence self-efficacy
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Perceived Stress Scale
Description
perceived stress burden
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
patricia weitzman
Organizational Affiliation
founder
Official's Role
Principal Investigator
Facility Information:
Facility Name
Environment and Health Group
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Digital Health for Medication Adherence Among African Americans With Hypertension
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