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Clinical Trials/NCT01968876
NCT01968876TerminatedEarly Phase 1

Is a Smartphone Application Effective as an Oral Medication Adherence Aid

University of Arkansas6 sites in 1 country68 target enrollmentStarted: October 30, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Early Phase 1
Status
Terminated
Enrollment
68
Locations
6
Primary Endpoint
Change from baseline in number of pills taken over number of pills prescribed at 4 weeks

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: Medication Adherence Smartphone App (Other)

Outcomes

Primary Outcomes

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

Time Frame: Change from baseline to 4 weeks

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

Time Frame: Change from baseline to 12 weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (6)

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