NCT03244267

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 3, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2019

Completed
Last Updated

October 23, 2019

Status Verified

October 1, 2019

Enrollment Period

1.4 years

First QC Date

August 7, 2017

Last Update Submit

October 21, 2019

Conditions

Keywords

Orthopedics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • AIDS Clinical Trials Group (ACTG) Adherence Questionnaire Score

    Post- Operative Visit (Day 36)

  • Aspirin (ASA) Self-Efficacy Scale Score

    Post- Operative Visit (Day 36)

  • Number of Thromboembolic Events

    Post- Operative Visit (Day 36)

  • Aspirin (ASA) General Adherence Scale Score

    Post- Operative Visit (Day 36)

  • Unified Theory of Acceptance and Use of Technology (UTAUT2) Survey Score

    Baseline (Pre-Intervention)

  • +4 more secondary outcomes

Study Arms (2)

Standard Education

ACTIVE COMPARATOR

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

Medication Reminder App + Standard Education

EXPERIMENTAL

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 EducationBehavioral: Medication Reminder App

Interventions

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.

Medication Reminder App + Standard EducationStandard Education

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.

Medication Reminder App + Standard Education

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory Orthopedic and Spine Hospital

Atlanta, Georgia, 30084, United States

Location

MeSH Terms

Conditions

Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Deborah Wittig-Wells, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Associate Professor

Study Record Dates

First Submitted

August 7, 2017

First Posted

August 9, 2017

Study Start

October 3, 2017

Primary Completion

March 8, 2019

Study Completion

March 8, 2019

Last Updated

October 23, 2019

Record last verified: 2019-10

Locations