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App Reminder on ASA Adherence

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ClinicalTrials.gov Identifier: NCT03244267
Recruitment Status : Recruiting
First Posted : August 9, 2017
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
National Association of Orthopedic Nurses
Information provided by (Responsible Party):
Deborah Wittig-Wells, RN, PhD, Emory University

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.


Condition or disease Intervention/treatment Phase
Thromboembolic Event Behavioral: Standard Education Behavioral: Medication Reminder App Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of a Smartphone App Reminder on Adherence Aspirin Prescribed as Anti-Thrombotic Therapy
Actual Study Start Date : October 3, 2017
Estimated Primary Completion Date : April 24, 2020
Estimated Study Completion Date : April 24, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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.




Primary Outcome Measures :
  1. Proportion of Pills Taken [ Time Frame: Post- Operative Visit (Day 36) ]
    The proportion of pills taken is defined as the percentage of pills taken by study participants.


Secondary Outcome Measures :
  1. AIDS Clinical Trials Group (ACTG) Adherence Questionnaire Score [ Time Frame: Post- Operative Visit (Day 36) ]
    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.

  2. Aspirin (ASA) Self-Efficacy Scale Score [ Time Frame: Post- Operative Visit (Day 36) ]
    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.

  3. Number of Thromboembolic Events [ Time Frame: Post- Operative Visit (Day 36) ]
    Clinical outcomes will be assessed at follow-up by self-report questions to ascertain if any thromboembolic events occurred.

  4. Aspirin (ASA) General Adherence Scale Score [ Time Frame: Post- Operative Visit (Day 36) ]
    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.

  5. Unified Theory of Acceptance and Use of Technology (UTAUT2) Survey Score [ Time Frame: Baseline (Pre-Intervention) ]
    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.

  6. Performance Expectancy Subscale Score [ Time Frame: Baseline (Pre-Intervention) ]
    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.

  7. Effort Expectancy Subscale Score [ Time Frame: Baseline (Pre-Intervention) ]
    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.

  8. Hedonic Motivation Subscale Score [ Time Frame: Baseline (Pre-Intervention) ]
    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.

  9. Behavioral Intent Subscale Score [ Time Frame: Baseline (Pre-Intervention) ]
    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.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03244267


Contacts
Contact: Deborah Wittig-Wells, PhD 704-300-7043 deborah.wittig-wells@emory.edu

Locations
United States, Georgia
Emory Orthopedic and Spine Hospital Recruiting
Atlanta, Georgia, United States, 30084
Contact: Deborah Wittig-Wells, PhD    704-300-7043    deborah.wittig-wells@emory.edu   
Sponsors and Collaborators
Emory University
National Association of Orthopedic Nurses
Investigators
Principal Investigator: Deborah Wittig-Wells, PhD Emory University

Responsible Party: Deborah Wittig-Wells, RN, PhD, Adjunct Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT03244267     History of Changes
Other Study ID Numbers: IRB00094970
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Deborah Wittig-Wells, RN, PhD, Emory University:
Orthopedics

Additional relevant MeSH terms:
Embolism and Thrombosis
Thromboembolism
Vascular Diseases
Cardiovascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics