App Reminder on ASA Adherence
Primary Purpose
Thromboembolic Event
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Education
Medication Reminder App
Sponsored by
About this trial
This is an interventional other trial for Thromboembolic Event focused on measuring Orthopedics
Eligibility Criteria
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
Sites / Locations
- Emory Orthopedic and Spine Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Education
Medication Reminder App + Standard Education
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Proportion of Pills Taken
The proportion of pills taken is defined as the percentage of pills taken by study participants.
Secondary Outcome Measures
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.
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.
Number of Thromboembolic Events
Clinical outcomes will be assessed at follow-up by self-report questions to ascertain if any thromboembolic events occurred.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03244267
First Posted
August 7, 2017
Last Updated
October 21, 2019
Sponsor
Emory University
Collaborators
National Association of Orthopaedic Nurses
1. Study Identification
Unique Protocol Identification Number
NCT03244267
Brief Title
App Reminder on ASA Adherence
Official Title
Impact of a Smartphone App Reminder on Adherence Aspirin Prescribed as Anti-Thrombotic Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 3, 2017 (Actual)
Primary Completion Date
March 8, 2019 (Actual)
Study Completion Date
March 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Association of Orthopaedic Nurses
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thromboembolic Event
Keywords
Orthopedics
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
195 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Education
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Medication Reminder App + Standard Education
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Medication Reminder App
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of Pills Taken
Description
The proportion of pills taken is defined as the percentage of pills taken by study participants.
Time Frame
Post- Operative Visit (Day 36)
Secondary Outcome Measure Information:
Title
AIDS Clinical Trials Group (ACTG) Adherence Questionnaire Score
Description
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.
Time Frame
Post- Operative Visit (Day 36)
Title
Aspirin (ASA) Self-Efficacy Scale Score
Description
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.
Time Frame
Post- Operative Visit (Day 36)
Title
Number of Thromboembolic Events
Description
Clinical outcomes will be assessed at follow-up by self-report questions to ascertain if any thromboembolic events occurred.
Time Frame
Post- Operative Visit (Day 36)
Title
Aspirin (ASA) General Adherence Scale Score
Description
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.
Time Frame
Post- Operative Visit (Day 36)
Title
Unified Theory of Acceptance and Use of Technology (UTAUT2) Survey Score
Description
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.
Time Frame
Baseline (Pre-Intervention)
Title
Performance Expectancy Subscale Score
Description
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.
Time Frame
Baseline (Pre-Intervention)
Title
Effort Expectancy Subscale Score
Description
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.
Time Frame
Baseline (Pre-Intervention)
Title
Hedonic Motivation Subscale Score
Description
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.
Time Frame
Baseline (Pre-Intervention)
Title
Behavioral Intent Subscale Score
Description
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.
Time Frame
Baseline (Pre-Intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Wittig-Wells, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Orthopedic and Spine Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30084
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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