Thromboembolic EventNCT03244267
App Reminder on ASA Adherence
A study testing Standard Education and Medication Reminder App in people with Thromboembolic Event, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Thromboembolic Event
- What is being tested?
- Standard Education and Medication Reminder App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2017to 8 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Diagnosis of mental illness
- Do not own a smart phone
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory Orthopedic and Spine Hospital
Atlanta, Georgia, 30084
About this study
Official title: 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.
Read the 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.
- Conditions
- Thromboembolic Event
- Being tested
- Standard Education, Medication Reminder App
- Keywords
- Orthopedics
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard EducationBehavioural
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 AppBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Education; Behavioral: Medication Reminder App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Pills Taken
The proportion of pills taken is defined as the percentage of pills taken by study participants.
Measured: Post- Operative Visit (Day 36)
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Pre-Intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start3 Oct 2017
- Primary completion8 Mar 2019
- Study completion8 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thromboembolic EventStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Association of Orthopaedic Nurses
- Responsible party
- Principal investigator, Deborah Wittig-Wells, RN, PhD, Emory University
- Investigators
- Deborah Wittig-Wells, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244267
- Sponsor's protocol ID
- IRB00094970
- Status last verified
- Oct 2019
- First submitted
- 7 Aug 2017
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Smartphone App Reminder on Adherence Aspirin Prescribed as Anti-Thrombotic Therapy
- ClinicalTrials.gov ID
- NCT03244267
- Acronym / sponsor ID
- IRB00094970
- Conditions
- Thromboembolic Event
- Keywords
- Orthopedics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Association of Orthopaedic Nurses
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Education | Active comparator | Behavioral: Standard EducationParticipants 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. |
| Medication Reminder App + Standard Education | Experimental | Behavioral: Standard Education, Behavioral: Medication Reminder AppParticipants 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Diagnosis of mental illness
- Do not own a smart phone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard EducationParticipants 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. | Behavioural | Medication Reminder App + Standard Education, Standard Education |
| Medication Reminder AppParticipants 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. | Behavioural | Medication Reminder App + Standard Education |
Primary outcome
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.
9 secondary outcomes
AIDS Clinical Trials Group (ACTG) Adherence Questionnaire Score
Time frame: Post- Operative Visit (Day 36)
Aspirin (ASA) Self-Efficacy Scale Score
Time frame: Post- Operative Visit (Day 36)
Number of Thromboembolic Events
Time frame: Post- Operative Visit (Day 36)
Aspirin (ASA) General Adherence Scale Score
Time frame: Post- Operative Visit (Day 36)
Unified Theory of Acceptance and Use of Technology (UTAUT2) Survey Score
Time frame: Baseline (Pre-Intervention)
Performance Expectancy Subscale Score
Time frame: Baseline (Pre-Intervention)
Effort Expectancy Subscale Score
Time frame: Baseline (Pre-Intervention)
Hedonic Motivation Subscale Score
Time frame: Baseline (Pre-Intervention)
Behavioral Intent Subscale Score
Time frame: Baseline (Pre-Intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Wittig-Wells, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Education and Medication Reminder App in people with Thromboembolic Event, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Pills Taken (time frame: Post- Operative Visit (Day 36)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.