search
Back to results

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

Primary Purpose

Medication Adherence, Self Efficacy

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medisafe smartphone mobile application
Printed medication list
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Medication Adherence focused on measuring Medication Knowledge, Medication Social Support, Medication Self Efficacy, Mobile Phone Applications, Medically Underserved Populations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • NCHC's Smilow Life Center
  • Norwalk Community Health Center, Inc. (NCHC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Participants using the medication adherence mobile application.

Participants using a printed copy of their medication list.

Arm Description

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

Participants in this arm will use a printed out copy of their medication list for thirty days.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 15, 2021
Last Updated
May 22, 2023
Sponsor
Vanderbilt University
search

1. Study Identification

Unique Protocol Identification Number
NCT05098743
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 19, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Adherence, Self Efficacy
Keywords
Medication Knowledge, Medication Social Support, Medication Self Efficacy, Mobile Phone Applications, Medically Underserved Populations

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants using the medication adherence mobile application.
Arm Type
Experimental
Arm Description
Participants in this arm will use the Medisafe app to receive medication reminders for thirty days.
Arm Title
Participants using a printed copy of their medication list.
Arm Type
Active Comparator
Arm Description
Participants in this arm will use a printed out copy of their medication list for thirty days.
Intervention Type
Behavioral
Intervention Name(s)
Medisafe smartphone mobile application
Intervention Description
The medication adherence smartphone mobile application (app) will provide reminders to take individual patient medications and offers medication information and a social support feature.
Intervention Type
Behavioral
Intervention Name(s)
Printed medication list
Intervention Description
Patients will receive a printed out medication list from their electronic medical record.
Primary Outcome Measure Information:
Title
Change in medication adherence as measured by the Adherence to Refills and Medications Scale (ARMS)
Description
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.
Time Frame
Baseline to 30 days.
Title
Change in medication self-efficacy as measured by the Self-efficacy for Appropriate Medication Use Scale (SEAMS)
Description
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.
Time Frame
Baseline to 30 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deonni P Stolldorf, RN, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Study Chair
Facility Information:
Facility Name
NCHC's Smilow Life Center
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06854
Country
United States
Facility Name
Norwalk Community Health Center, Inc. (NCHC)
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06854
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs