Digital Health for Medication Adherence Among African Americans With Hypertension

NCT05009004 | Completed Results

• 1 other identifier: 1R43MD015969-01A1
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

medication adherence

Outcome Measures

Primary Outcomes (2)

• 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.

  6 weeks

• 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.

  6 weeks

Secondary Outcomes (1)

• Perceived Stress Scale

  6 weeks

Study Arms (1)

Digital health intervention using text messages to support medication adherence

EXPERIMENTAL

In this one-arm, pre-post evaluation, all participants will receive the digital health intervention consisting of daily text messages to support medication adherence.

Behavioral: text messages to support medication adherence

Interventions

text messages to support medication adherence BEHAVIORAL

text messages to support medication adherence

Digital health intervention using text messages to support medication adherence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Environment and Health Group, Inc.: lead

Study Sites (1)

Environment and Health Group

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Hypertension; Medication Adherence

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Patricia Weitzman
• Organization: Environment and Health Group

pat.weitzman@ehgcambridge.com

6174555976

Study Officials

• patricia weitzman

  founder

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

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

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 17, 2021
• Study Start: October 14, 2022
• Primary Completion: June 23, 2023
• Study Completion: October 30, 2023
• Last Updated: December 31, 2024
• Results First Posted: December 31, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)