Is a Smartphone Application Effective as an Oral Medication Adherence Aid

NCT01968876 | Terminated Early Phase 1

• 1 other identifier: 202266
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Hypertension; Diabetes; Dyslipidemia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Standard Care

NO INTERVENTION

The control group will not use the medication adherence app

Medication Adherence Smartphone App

EXPERIMENTAL

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

Interventions

Medication Adherence Smartphone App OTHER

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.

Also known as: MyMedSchedule

Medication Adherence Smartphone App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (3)

Internal Medicine Clinic North; University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Remedy Drug

Little Rock, Arkansas, 72205, United States

Location

Internal Medicine Clinic West; University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72211, United States

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus; Dyslipidemias

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders

Study Officials

• Paul H Anderson

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 24, 2013
• Study Start: October 30, 2013
• Primary Completion: November 14, 2017
• Study Completion: November 14, 2017
• Last Updated: November 20, 2017

Record last verified: 2017-11

Locations

US (3)