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

Medication Adherence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05098743
• Other study ID #: 211409
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 19, 2021
• Est. completion date: July 30, 2023

Study information

• Verified date: May 2023
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: July 30, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Medication Adherence
• Self Efficacy

Intervention

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

Locations

Country	Name	City	State
United States	NCHC's Smilow Life Center	Norwalk	Connecticut
United States	Norwalk Community Health Center, Inc. (NCHC)	Norwalk	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.