Is a Smartphone Application Effective as an Oral Medication Adherence Aid

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Arkansas
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01968876
First received: October 10, 2013
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Hypertension
Diabetes
Dyslipidemia
Other: Medication Adherence Smartphone App
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Is a Smartphone Application Effective as an Oral Medication Adherence Aid

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Change from baseline in number of pills taken over number of pills prescribed at 4 weeks [ Time Frame: Change from baseline to 4 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in number of pills taken over number of pills prescribed at 12 weeks [ Time Frame: Change from baseline to 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 228
Study Start Date: October 2013
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: MyMedSchedule

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01968876

Contacts
Contact: Paul H Anderson 5018128561 panderson3@uams.edu

Locations
United States, Arkansas
Internal Medicine Clinic North; University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Principal Investigator: Paul H Anderson         
Sub-Investigator: Bradley Martin         
Sub-Investigator: Erin Vaughn         
Internal Medicine Clinic West; University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72211
Principal Investigator: Paul H Anderson         
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Paul H Anderson University of Arkansas
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01968876     History of Changes
Other Study ID Numbers: 202266
Study First Received: October 10, 2013
Last Updated: April 30, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Dyslipidemias
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 29, 2014