The Influence of a Medication Adherence Smartphone Application on Medication Adherence in Chronic Illness

NCT ID: NCT05098743

Last Updated: 2024-08-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-19

Study Completion Date

2022-09-01

Brief Summary

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Medication adherence is a critical aspect of achieving optimal health outcomes. Thirty to 50% of patients adhere to long-term medication treatment of chronic diseases. Non adherence has been shown to result in worsening disease, increased healthcare expenditures, complications and even death. Medically underserved communities have higher rates of medication nonadherence and a higher prevalence of chronic conditions and often receive care at Federally Qualified Health Centers (FQHCs) which are reporting caring for increasingly complex chronic conditions. Smartphone mobile phone ownership has increased to 76% in low income Americans, but this population has been underrepresented in mobile health intervention studies. This two-group, cluster randomized by site, randomized controlled trial will investigate the effect of a medication adherence smartphone mobile application (app) which provides reminders on patient medication adherence, on medication self-efficacy, medication knowledge and medication social support. Independently, each of these concepts have been shown to support medication adherence. However in the context of delivery by a medication adherence app in a variety of chronic illnesses in a medically underserved population, little is known. It will also explore if those who accessed educational materials within the app report greater medication knowledge than those who do not and if participants who choose to use the additional Medfriend feature report greater medication social support than those who do not. The study will also explore patients' perceptions on the usefulness and satisfaction with the app features.

Detailed Description

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Medication adherence is a critical aspect of achieving optimal health outcomes. Thirty to 50% of patients adhere to long-term medication treatment of chronic diseases. Non adherence has been shown to result in worsening disease, increased healthcare expenditures, complications and even death. Medically underserved communities have higher rates of medication nonadherence and a higher prevalence of chronic conditions and often receive care at Federally Qualified Health Centers (FQHCs) which are reporting caring for increasingly complex chronic conditions. Smartphone mobile phone ownership has increased to 76% in low income Americans, but this population has been underrepresented in mobile health intervention studies. This two-group, cluster randomized by site, randomized controlled trial will investigate the effect of a medication adherence smartphone mobile application (app) which provides reminders on patient medication adherence, on medication self-efficacy, medication knowledge and medication social support. Independently, each of these concepts have been shown to support medication adherence. However in the context of delivery by a medication adherence app in a variety of chronic illnesses in a medically underserved population, little is known. It will also explore if those who accessed educational materials within the app report greater medication knowledge than those who do not and if participants who choose to use the additional Medfriend feature report greater medication social support than those who do not. The study will also explore patients' perceptions on the usefulness and satisfaction with the app features.

Conditions

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Medication Adherence Self Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Participants using the medication adherence mobile application.

Participants in this arm will use the Medisafe app to receive medication reminders for thirty days.

Group Type EXPERIMENTAL

Medisafe smartphone mobile application

Intervention Type BEHAVIORAL

The medication adherence smartphone mobile application (app) will provide reminders to take individual patient medications and offers medication information and a social support feature.

Participants using a printed copy of their medication list.

Participants in this arm will use a printed out copy of their medication list for thirty days.

Group Type ACTIVE_COMPARATOR

Printed medication list

Intervention Type BEHAVIORAL

Patients will receive a printed out medication list from their electronic medical record.

Interventions

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Medisafe smartphone mobile application

The medication adherence smartphone mobile application (app) will provide reminders to take individual patient medications and offers medication information and a social support feature.

Intervention Type BEHAVIORAL

Printed medication list

Patients will receive a printed out medication list from their electronic medical record.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* adults aged 18 years and older
* speak and understand English
* personally own and use an Android or Apple smartphone and
* take at least 1 medication for a chronic illness based on their computerized medical record at the health center.

Exclusion Criteria

* already using a medication reminder app or other electronic reminder system such as phone alarms
* own smartphones that are not capable of downloading the app
* patients with severe dementia or serious mental illness, and
* inability to use a mobile phone or the medication reminder software either physically or cognitively.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Christa Hartch

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deonni P Stolldorf, PhD, RN

Role: STUDY_CHAIR

Vanderbilt University

Locations

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NCHC's Smilow Life Center

Norwalk, Connecticut, United States

Site Status

Norwalk Community Health Center, Inc. (NCHC)

Norwalk, Connecticut, United States

Site Status

Countries

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United States

References

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Hartch C, Dietrich MS, Lancaster BJ, Mulvaney SA, Stolldorf DP. Satisfaction and Usability of a Commercially Available Medication Adherence App (Medisafe) Among Medically Underserved Patients With Chronic Illnesses: Survey Study. JMIR Hum Factors. 2025 Jan 7;12:e63653. doi: 10.2196/63653.

Reference Type DERIVED
PMID: 39773694 (View on PubMed)

Hartch CE, Dietrich MS, Lancaster BJ, Stolldorf DP, Mulvaney SA. Effects of a medication adherence app among medically underserved adults with chronic illness: a randomized controlled trial. J Behav Med. 2024 Jun;47(3):389-404. doi: 10.1007/s10865-023-00446-2. Epub 2023 Dec 21.

Reference Type DERIVED
PMID: 38127174 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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211409

Identifier Type: -

Identifier Source: org_study_id

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