App Reminder on ASA Adherence

Impact of a Smartphone App Reminder on Adherence Aspirin Prescribed as Anti-Thrombotic Therapy

The purpose of this study is to explore the impact of using a smartphone app reminder on medication adherence twice daily in adults prescribed 81 milligrams of aspirin for 35 days as anti-thrombotic therapy after knee or hip arthroplasty.

This study will randomly assign participants to get usual postoperative care which is teaching with verbal instructions and printed information about taking the aspirin at the time of discharge, or to have an app on your smartphone with preset reminders in addition to usual postoperative discharge teaching after surgery.

Study Overview

• Status: Completed
• Conditions: Thromboembolic Event
• Intervention / Treatment: Behavioral: Standard Education; Behavioral: Medication Reminder App

Detailed Description

The purpose of this study is to evaluate the impact of using a smartphone application (app) reminder on medication adherence twice daily in 200 adults prescribed 81 milligrams of aspirin (ASA) for 35 days as anti-thrombotic therapy after knee or hip arthroplasty. The aim is to determine if an app downloaded on a smartphone that reminds patients twice a day to take their ASA as prescribed will improve ASA adherence and clinical outcomes for patients after total knee and total hip joint arthroplasty compared to those in the usual care.

This is a two group, randomized control study with random assignment into the control group for usual care or the intervention group to receive a medication reminder app for their smart phone (daily for 35 days) plus usual care. Participants will receive a baseline interview for demographic and other data and 36 day follow-up assessment, both conducted in person.

• Study Type: Interventional
• Enrollment (Actual): 195
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30084
      • Emory Orthopedic and Spine Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Prescribed aspirin 81 mg twice a day for 35 days
• Ability to write and speak English
• Have a smart phone with the capacity to download and set an app
• Own and use a smart phone for communication purposes

Exclusion Criteria:

• Diagnosis of mental illness
• Do not own a smart phone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Education; Participants randomized to this arm will receive the standard education provided to patients about the importance of taking aspirin to prevent thromboembolic events after orthopedic surgery.	Behavioral: Standard Education; Participants will receive the usual verbal education and printed information provided to patients about the importance of taking aspirin to prevent thromboembolic events after orthopedic surgery, medication dosage and scheduling.
Experimental: Medication Reminder App + Standard Education; Participants randomized to this arm will use a smartphone app with preset reminders to take aspirin to prevent thromboembolic events after orthopedic surgery in addition to usual postoperative discharge teaching.	Behavioral: Standard Education; Participants will receive the usual verbal education and printed information provided to patients about the importance of taking aspirin to prevent thromboembolic events after orthopedic surgery, medication dosage and scheduling.; Behavioral: Medication Reminder App; Participants will use a medication reminder app that is set in collaboration with the participants for times that fit into their daily lifestyle. The app will alert participants when it is time (selected by the participant) to take their medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Pills Taken	The proportion of pills taken is defined as the percentage of pills taken by study participants.	Post- Operative Visit (Day 36)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AIDS Clinical Trials Group (ACTG) Adherence Questionnaire Score	The ACTG Adherence Questionnaire consists of 19 items measuring different aspects of efficacy (or confidence) in the management of one's medication. Each item is rated from 0 ("I cannot do at all") to 10 ("Sure I can do"), with total scores found by summing responses to individual items and dividing by 19. Higher scores correspond to higher levels of medication self-efficacy.	Post- Operative Visit (Day 36)
Aspirin (ASA) Self-Efficacy Scale Score	The ASA Self-Efficacy Scale consists of 19 items measuring different aspects of efficacy (or confidence) in the management of one's medication. Each item is rated from 0 ("I cannot do at all") to 10 ("Sure I can do"), with total scores found by summing responses to individual items and dividing by 19. Higher scores correspond to higher levels of medication self-efficacy.	Post- Operative Visit (Day 36)
Number of Thromboembolic Events	Clinical outcomes will be assessed at follow-up by self-report questions to ascertain if any thromboembolic events occurred.	Post- Operative Visit (Day 36)
Aspirin (ASA) General Adherence Scale Score	The ASA General Adherence Scale measures the ease and ability to adhere to the ASA regimen as prescribed. It is scored by summing responses to the individual items and creating a total score. Higher scores indicate better self-reported adherence.	Post- Operative Visit (Day 36)
Unified Theory of Acceptance and Use of Technology (UTAUT2) Survey Score	The UTAUT2 measures antecedents (performance expectancy, effort expectancy, hedonic motivation) and behavioral intent to use mobile apps. Items are scored using a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree). Survey totals range between 14 and 112. Higher scores are indicative of greater acceptance and intent to adopt the target technology.	Baseline (Pre-Intervention)
Performance Expectancy Subscale Score	The Performance Expectancy Subscale measures the perceived benefits of mobile app technology to the consumer. Scores range from 4 to 28, with higher totals indicating better perceptions of technology-related benefits.	Baseline (Pre-Intervention)
Effort Expectancy Subscale Score	The Effort Expectancy Subscale measures the ease with which the consumer can learn and operate an app. Scores range from 4 to 28, with higher totals indicating greater beliefs that the technology is easy and accessible.	Baseline (Pre-Intervention)
Hedonic Motivation Subscale Score	The Hedonic Motivation subscale measures the enjoyment, the consumer experiences from using an app. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (Absolutely True) to 7 (Absolutely Untrue). Scoring is kept continuous with higher scores indicating greater enjoyment.	Baseline (Pre-Intervention)
Behavioral Intent Subscale Score	The Behavioral Intent Subscale measures the decision to use a mobile app. Scores range from 3 to 21, with higher totals indicating a greater intent to use or adopt an app.	Baseline (Pre-Intervention)

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Association of Orthopaedic Nurses
• Investigators: Principal Investigator: Deborah Wittig-Wells, PhD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2017
• Primary Completion (Actual): March 8, 2019
• Study Completion (Actual): March 8, 2019

Study Registration Dates

• First Submitted: August 7, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (Actual): August 9, 2017

Study Record Updates

• Last Update Posted (Actual): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Orthopedics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism
• Other Study ID Numbers: IRB00094970

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No