Is a Smartphone Application Effective as an Oral Medication Adherence Aid

This research will act as a pilot study that will be conducted to determine the effectiveness of a smartphone medication adherence application on adherence to oral hypertensive, diabetic, and dyslipidemic medications using a prospective randomized design. Subjects will be recruited from the University of Arkansas for Medical Sciences (UAMS) Internal Medicine Clinic North, and the study data will be collected using only subject self-reports and subject pharmacy records.

Study Overview

• Status: Terminated
• Conditions: Hypertension; Diabetes; Dyslipidemia
• Intervention / Treatment: Other: Medication Adherence Smartphone App

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Internal Medicine Clinic North; University of Arkansas for Medical Sciences
    • Little Rock, Arkansas, United States, 72205
      • Remedy Drug
    • Little Rock, Arkansas, United States, 72211
      • Internal Medicine Clinic West; University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and females at least 18 years of age
• Provide informed consent
• Prescribed an oral medication indicated for hypertension, diabetes, or dyslipidemia during 12 weeks pre-enrollment
• Own a smartphone (Android or iOS) with unlimited text messaging, email access, and app store access
• Oral confirmation that the subject has not previously used a medication adherence app
• Able to consult with a pharmacy or medical student during the recruitment process for purposes of consent, data collection, and/or medication reconciliation, and/or MyMedSchedule registration

Exclusion Criteria:

• Severely impaired vision
• Reside in a nursing home
• Non-ambulatory/bedridden
• Not fluent in English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care; The control group will not use the medication adherence app
Experimental: Medication Adherence Smartphone App; The experimental group will receive the medication adherence app on their smartphone and will have their entire outpatient medication list pushed to the application. Text message reminders will be sent to their phones at the appropriate times.	Other: Medication Adherence Smartphone App; MyMedSchedule is a consumer-grade smartphone application currently available on various marketplaces of the Android and iOS platforms that acts as a portal to the free service MyMedSchedule.com website. It can interface with the MedActionPlan discharge planning tool for providers by automatically populating fields, allowing medication lists to be pushed to a subject's MyMedSchedule account, allowing the input of complex medication regimens, and aiding in medication reconciliation. A MyMedSchedule account can be setup with the patient's name, date of birth, allergies, emergency contact, healthcare providers, insurance plan information, and complete medication list. Medication dose and refill reminders can be set and sent through short message service (SMS) text message or e-mail. SMS text message reminders will be used for this study.; Other Names: MyMedSchedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in number of pills taken over number of pills prescribed at 4 weeks	Change from baseline to 4 weeks
Change from baseline in number of pills taken over number of pills prescribed at 12 weeks	Change from baseline to 12 weeks

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Paul H Anderson, University of Arkansas

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2013
• Primary Completion (Actual): November 14, 2017
• Study Completion (Actual): November 14, 2017

Study Registration Dates

• First Submitted: October 10, 2013
• First Submitted That Met QC Criteria: October 18, 2013
• First Posted (Estimate): October 24, 2013

Study Record Updates

• Last Update Posted (Actual): November 20, 2017
• Last Update Submitted That Met QC Criteria: November 16, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: 202266