Pill Bottle vs Reminder App

June 10, 2024 updated by: Washington University School of Medicine

Feasibility of Interventions Impacting Medication Adherence

Current medication adherence interventions are minimally effective, which results in higher rates of morbidity and mortality for 45 million US adults who have hypertension and low adherence. This feasibility randomized controlled trial seeks to understand the efficacy of reminders and monitoring in the form of a mobile phone application vs usual care on medication adherence as well as the feasibility of the intervention and study procedures. This study will compare participants who use a mobile phone app that notifies them when to take their medications (intervention group) to participants who do not get assigned the app (control group) for 30 days. Medication adherence will be monitored using a Medication Event Monitoring System (MEMS) cap. Both groups will also receive the usual care, which will include giving participants a pamphlet about taking their medications. The long-term goal of this work is to improve antihypertensive medication adherence and to decrease morbidity and mortality. The objective of this application is to test the efficacy of the app based reminders and feedback. The hypothesis driving this research is that the intervention will be more effective than the usual care. The specific aims are as follows:

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Current medication adherence interventions are minimally effective, which results in higher rates of morbidity and mortality for 45 million US adults who have hypertension and low adherence. This feasibility randomized controlled trial seeks to understand the efficacy of reminders and monitoring in the form of a mobile phone application vs usual care on medication adherence as well as the feasibility of the intervention and study procedures. This study will compare participants who use a mobile phone app that notifies them when to take their medications (intervention group) to participants who do not get assigned the app (control group) for 30 days. Participants will receive an electronic monitoring cap (i.e. a Medication Event Monitoring System (MEMS) cap) to monitor when they take their antihypertensive medications while they are in the study. Both groups will also receive the usual care, which will include giving participants a pamphlet about taking their medications. The long-term goal of this work is to improve antihypertensive medication adherence and to decrease morbidity and mortality. The objective of this application is to test the efficacy of the app based reminders and feedback. The hypothesis driving this research is that the intervention will be more effective than the usual care. The specific aims are as follows:

Aim 1. Compare the efficacy of the app based reminders and feedback with usual care for the primary outcome of medication adherence in 40 adults with hypertension and low adherence.

Aim 2. Conduct a robust process evaluation to guide intervention improvements, dissemination, and implementation in a diverse sample.

The hypothesis will be tested for two specific aims in 40 adults (20 control, 20 intervention) with hypertension and low adherence. For these aims, the study will be conducted as a phase II single-blind, parallel-group, randomized controlled trial with diverse adults with hypertension over 30 days. Participants will answer surveys about their demographics, knowledge about hypertension, and their medication adherence. They will then be randomized and either be given the standard of care or standard of care plus the intervention (app-based reminders and feedback). The intervention includes a brief training session on downloading and using the medication reminder app. Across arms, Participants will track their medication adherence for 30 days using the MEMS cap. After the 30 days, participants will take surveys about their adherence and knowledge about hypertension and have a brief exit interview with a member of the research team to talk about their experience and debrief them about the study.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University in St. Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • currently be prescribed an antihypertensive medication by their doctor
  • have taken antihypertensive medication for the last year
  • be willing to download and use a new app on their phone for the study
  • score a 34 or lower on the Hill Bone compliance scale

Exclusion Criteria:

  • need assistance taking their medications
  • have a severe cognitive impairment
  • have a severe visual impairment that prevents them from reading notifications on their phone
  • use a pillbox to take their medications
  • do not use a smart phone or their smart phone does not meet the requirements for the app to be downloaded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: MEMS Cap Only

If the participant is randomized to the control group, they will:

  1. receive a brief education session and be handed a flyer about the importance of medication adherence
  2. receive a MEMS cap and be given instructions on how to use it with their blood pressure medication
Active Comparator: Medication Reminder App + MEMS Cap
Intervention group that will be shown how to use the mobile phone medication reminder app and be given assistance downloading and setting it up on their personal phone.
Device: Medication Reminder App

If the participant is randomized to the intervention group, they will:

  1. receive a brief education session and be handed a flyer about the importance of medication adherence.
  2. get training on how to use the medication reminder app and participant will be given a user guide on how to use the app
  3. demonstrate their understanding on an iPad using the teach back method
  4. install and set up the medication reminder app on their phone
  5. receive a MEMS cap and be given instructions on how to use it with their blood pressure medication. Study team members will use a participant ID to log into the MEMS cap application; no identifiable information will be entered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication Event Monitoring System (MEMS) Cap
Time Frame: 30 days
The Medication Event Monitoring System (MEMS) measures medication adherence over 30 days at home. In this system, an electronic cap will be placed on a bottle assigned to the participant's antihypertensive medication and records each time the medication bottle is opened. All participants will use the electronic monitoring for one antihypertensive medication taken daily.
30 days
Exit interview
Time Frame: 30 days
In the exit interview, participants will be asked qualitative questions about their experiences in the study and using the MEMS cap and medication reminder app. This will support a robust process evaluation to guide intervention improvements, dissemination, and implementation in a diverse sample.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Jaclyn Schwartz, PhD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2023

Primary Completion (Actual)

May 2, 2024

Study Completion (Actual)

May 2, 2024

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202306153

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in any publications, after deidentification (text, tables, figures, and appendices).

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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