The Influence of a Medication Adherence… | Clinical Trial

Key information

Conditions

Medication Adherence Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Self Efficacy Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NCHC's Smilow Life Center, Norwalk, Connecticut, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Medisafe smartphone mobile application

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.

Printed medication list

Behavioral

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

Primary outcomes

Change in Medication Adherence as Measured by the Adherence to Refills and Medications Scale (ARMS)

Time frame: Baseline to 30 days.

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.
Change in Medication Self-efficacy as Measured by the Self-efficacy for Appropriate Medication Use Scale (SEAMS)

Time frame: Baseline to 30 days.

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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Oct 28, 2021
Registry last updated: Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed