Is a Smartphone Application Effective as an Oral Medication Adherence Aid

Hypertension Clinical Trial

Official title:

Is a Smartphone Application Effective as an Oral Medication Adherence Aid

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01968876
• Other study ID #: 202266
• Status: Terminated
• Phase: Early Phase 1
• First received: October 10, 2013
• Last updated: November 16, 2017
• Start date: October 30, 2013
• Est. completion date: November 14, 2017

Study information

• Verified date: November 2017
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: November 14, 2017
• Est. primary completion date: November 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Dyslipidemia
• Dyslipidemias
• Hypertension

Intervention

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.

Locations

Country	Name	City	State
United States	Internal Medicine Clinic North; University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Internal Medicine Clinic West; University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Remedy Drug	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in number of pills taken over number of pills prescribed at 4 weeks		Change from baseline to 4 weeks
Primary	Change from baseline in number of pills taken over number of pills prescribed at 12 weeks		Change from baseline to 12 weeks