Clinical trial NCT03244267: App Reminder on ASA Adherence
Official title: Impact of a Smartphone App Reminder on Adherence Aspirin Prescribed as Anti-Thrombotic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thromboembolic Event
Keywords: Orthopedics
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Association of Orthopaedic Nurses
First posted: 2017-08-09
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Proportion of Pills Taken
timeFrame: Post- Operative Visit (Day 36)
Secondary outcomes:
measure: AIDS Clinical Trials Group (ACTG) Adherence Questionnaire Score
timeFrame: Post- Operative Visit (Day 36)
measure: Aspirin (ASA) Self-Efficacy Scale Score
timeFrame: Post- Operative Visit (Day 36)
measure: Number of Thromboembolic Events
timeFrame: Post- Operative Visit (Day 36)
measure: Aspirin (ASA) General Adherence Scale Score
timeFrame: Post- Operative Visit (Day 36)
measure: Unified Theory of Acceptance and Use of Technology (UTAUT2) Survey Score
timeFrame: Baseline (Pre-Intervention)
measure: Performance Expectancy Subscale Score
timeFrame: Baseline (Pre-Intervention)
measure: Effort Expectancy Subscale Score
timeFrame: Baseline (Pre-Intervention)
measure: Hedonic Motivation Subscale Score
timeFrame: Baseline (Pre-Intervention)
measure: Behavioral Intent Subscale Score
timeFrame: Baseline (Pre-Intervention)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Orthopedic and Spine Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Deborah Wittig-Wells, PhD
role: PRINCIPAL_INVESTIGATOR
References: