search
Back to results

Is a Smartphone Application Effective as an Oral Medication Adherence Aid

Primary Purpose

Hypertension, Diabetes, Dyslipidemia

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Medication Adherence Smartphone App
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypertension

Eligibility Criteria

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

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

Sites / Locations

  • Internal Medicine Clinic North; University of Arkansas for Medical Sciences
  • Remedy Drug
  • Internal Medicine Clinic West; University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Care

Medication Adherence Smartphone App

Arm Description

The control group will not use the medication adherence 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.

Outcomes

Primary Outcome Measures

Change from baseline in number of pills taken over number of pills prescribed at 4 weeks
Change from baseline in number of pills taken over number of pills prescribed at 12 weeks

Secondary Outcome Measures

Full Information

First Posted
October 10, 2013
Last Updated
November 16, 2017
Sponsor
University of Arkansas
search

1. Study Identification

Unique Protocol Identification Number
NCT01968876
Brief Title
Is a Smartphone Application Effective as an Oral Medication Adherence Aid
Official Title
Is a Smartphone Application Effective as an Oral Medication Adherence Aid
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
Study had a minor contingency that could not be resolved with the IRB.
Study Start Date
October 30, 2013 (Actual)
Primary Completion Date
November 14, 2017 (Actual)
Study Completion Date
November 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes, Dyslipidemia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
The control group will not use the medication adherence app
Arm Title
Medication Adherence Smartphone App
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Medication Adherence Smartphone App
Other Intervention Name(s)
MyMedSchedule
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in number of pills taken over number of pills prescribed at 4 weeks
Time Frame
Change from baseline to 4 weeks
Title
Change from baseline in number of pills taken over number of pills prescribed at 12 weeks
Time Frame
Change from baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul H Anderson
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Internal Medicine Clinic North; University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Remedy Drug
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Internal Medicine Clinic West; University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Is a Smartphone Application Effective as an Oral Medication Adherence Aid

We'll reach out to this number within 24 hrs