Clinical trial NCT05098743: The Influence of a Medication Adherence Smartphone Application on Medication Adherence in Chronic Illness
Official title: The Influence of a Medication Adherence Smartphone Application on Medication Adherence in Chronic Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Self Efficacy
Keywords: Medication Knowledge
Medication Social Support
Medication Self Efficacy
Mobile Phone Applications
Medically Underserved Populations
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Medication Adherence as Measured by the Adherence to Refills and Medications Scale (ARMS)
timeFrame: Baseline to 30 days.
measure: Change in Medication Self-efficacy as Measured by the Self-efficacy for Appropriate Medication Use Scale (SEAMS)
timeFrame: Baseline to 30 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Norwalk
country: United States
facility: NCHC's Smilow Life Center
state: Connecticut
city: Norwalk
country: United States
facility: Norwalk Community Health Center, Inc. (NCHC)
state: Connecticut
Study officials:
affiliation: Vanderbilt University
name: Deonni P Stolldorf, PhD, RN
role: STUDY_CHAIR
References: