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

Sponsor

Vanderbilt University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05098743

Collaborator

(none)

Enrollment

Locations

Arms

11.4

Anticipated Duration (Months)

37.5

Patients Per Site

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Medication Adherence Self Efficacy	Behavioral: Medisafe smartphone mobile application Behavioral: Printed medication list	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Nov 19, 2021

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Participants using the medication adherence mobile application. Participants in this arm will use the Medisafe app to receive medication reminders for thirty days.	Behavioral: 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.
Active Comparator: 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.	Behavioral: Printed medication list Patients will receive a printed out medication list from their electronic medical record.

Arm

Intervention/Treatment

Experimental: Participants using the medication adherence mobile application.

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

Behavioral: 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.

Active Comparator: 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.

Behavioral: Printed medication list

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

Outcome Measures

Primary Outcome Measures

Change in medication adherence as measured by the Adherence to Refills and Medications Scale (ARMS) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

adults aged 18 years and older
speak and understand English
personally own and use an Android or iOS 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.