The Influence of a Medication Adherence Smartphone Application on Medication Adherence in Chronic Illness
1 other identifier
interventional
65
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2021
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2021
CompletedFirst Posted
Study publicly available on registry
October 28, 2021
CompletedStudy Start
First participant enrolled
November 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedResults Posted
Study results publicly available
August 19, 2024
CompletedAugust 19, 2024
March 1, 2024
10 months
October 15, 2021
August 18, 2023
March 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Medication Adherence as Measured by the Adherence to Refills and Medications Scale (ARMS)
The ARMS is a global (continuous) 12-item scale, responses range from 1 (none) to 4 (all of the time) with a possible score of 12-48, patients with low ARMS scores indicate better adherence, it is valid and reliable in a low-literacy chronic disease population.
Baseline to 30 days.
Change in Medication Self-efficacy as Measured by the Self-efficacy for Appropriate Medication Use Scale (SEAMS)
The SEAMS is a global (continuous) 13-item scale, responses range from 1 (not confident) to 3 (very confident), with a possible score of 13-39. Patients with higher scores indicate higher levels of self-efficacy for medication adherence. It is valid and reliable in low-literacy chronic disease populations. Patients are asked their level of confidence about taking medications correctly.
Baseline to 30 days.
Study Arms (2)
Participants using the medication adherence mobile application.
EXPERIMENTALParticipants in this arm will use the Medisafe app to receive medication reminders for thirty days.
Participants using a printed copy of their medication list.
ACTIVE COMPARATORParticipants in this arm will use a printed out copy of their medication list for thirty days.
Interventions
The medication adherence smartphone mobile application (app) will provide reminders to take individual patient medications and offers medication information and a social support feature.
Patients will receive a printed out medication list from their electronic medical record.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
NCHC's Smilow Life Center
Norwalk, Connecticut, 06854, United States
Norwalk Community Health Center, Inc. (NCHC)
Norwalk, Connecticut, 06854, United States
Related Publications (2)
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.
PMID: 39773694DERIVEDHartch 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.
PMID: 38127174DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Christa Hartch, PI
- Organization
- Vanderbilt University
Study Officials
- STUDY CHAIR
Deonni P Stolldorf, PhD, RN
Vanderbilt University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 15, 2021
First Posted
October 28, 2021
Study Start
November 19, 2021
Primary Completion
September 1, 2022
Study Completion
September 1, 2022
Last Updated
August 19, 2024
Results First Posted
August 19, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share