App Reminder on ASA Adherence
2019年10月21日 更新者：Deborah Wittig-Wells, RN, PhD、Emory University
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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
195
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Georgia
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Atlanta、Georgia、アメリカ、30084
- Emory Orthopedic and Spine Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～64年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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.
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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.
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実験的：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.
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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.
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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of Pills Taken
時間枠：Post- Operative Visit (Day 36)
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The proportion of pills taken is defined as the percentage of pills taken by study participants.
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Post- Operative Visit (Day 36)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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AIDS Clinical Trials Group (ACTG) Adherence Questionnaire Score
時間枠：Post- Operative Visit (Day 36)
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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.
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Post- Operative Visit (Day 36)
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Aspirin (ASA) Self-Efficacy Scale Score
時間枠：Post- Operative Visit (Day 36)
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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.
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Post- Operative Visit (Day 36)
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Number of Thromboembolic Events
時間枠：Post- Operative Visit (Day 36)
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Clinical outcomes will be assessed at follow-up by self-report questions to ascertain if any thromboembolic events occurred.
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Post- Operative Visit (Day 36)
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Aspirin (ASA) General Adherence Scale Score
時間枠：Post- Operative Visit (Day 36)
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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.
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Post- Operative Visit (Day 36)
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Unified Theory of Acceptance and Use of Technology (UTAUT2) Survey Score
時間枠：Baseline (Pre-Intervention)
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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.
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Baseline (Pre-Intervention)
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Performance Expectancy Subscale Score
時間枠：Baseline (Pre-Intervention)
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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.
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Baseline (Pre-Intervention)
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Effort Expectancy Subscale Score
時間枠：Baseline (Pre-Intervention)
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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.
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Baseline (Pre-Intervention)
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Hedonic Motivation Subscale Score
時間枠：Baseline (Pre-Intervention)
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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.
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Baseline (Pre-Intervention)
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Behavioral Intent Subscale Score
時間枠：Baseline (Pre-Intervention)
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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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Baseline (Pre-Intervention)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Deborah Wittig-Wells, PhD、Emory University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年10月3日
一次修了 (実際)
2019年3月8日
研究の完了 (実際)
2019年3月8日
試験登録日
最初に提出
2017年8月7日
QC基準を満たした最初の提出物
2017年8月7日
最初の投稿 (実際)
2017年8月9日
学習記録の更新
投稿された最後の更新 (実際)
2019年10月23日
QC基準を満たした最後の更新が送信されました
2019年10月21日
最終確認日
2019年10月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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