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HypertensionNCT05009004

Digital Health for Medication Adherence Among African Americans With Hypertension

A study testing text messages to support medication adherence in people with Hypertension, run by Environment and Health Group, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hypertension
What is being tested?
text messages to support medication adherence
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
14 Oct 2022to 30 Oct 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Environment and Health Group

    Cambridge, Massachusetts, 02138

Other trials in United States

About this study

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.

Read the 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
Being tested
text messages to support medication adherence
Keywords
medication adherence
Medical subject headings
Hypertension, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • text messages to support medication adherenceBehavioural

    text messages to support medication adherence

Study groups in NCT05009004
Study groupRoleWhat they receive
Digital health intervention using text messages to support medication adherenceExperimentalIn this one-arm, pre-post evaluation, all participants will receive the digital health intervention consisting of daily text messages to support medication adherence.
Receives: Behavioral: text messages to support medication adherence

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 weeks

  2. 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.

    Measured: 6 weeks

Secondary outcomes (1)
  1. 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.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2021
  2. Study start14 Oct 2022
  3. Primary completion23 Jun 2023
  4. Study completion30 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
Feasibility study involving pre-post evaluation of a digital health intervention on hypertension medication adherence.
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05009004
Sponsor's protocol ID
1R43MD015969-01A1
Status last verified
Nov 2024
First submitted
10 Aug 2021
Last updated
31 Dec 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing text messages to support medication adherence in people with Hypertension, run by Environment and Health Group, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wilson Self Report Medication Adherence Scale (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.

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