App Reminder on ASA Adherence
21 de octubre de 2019 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
195
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Georgia
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Atlanta, Georgia, Estados Unidos, 30084
- Emory Orthopedic and Spine Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 64 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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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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.
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proportion of Pills Taken
Periodo de tiempo: Post- Operative Visit (Day 36)
|
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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
AIDS Clinical Trials Group (ACTG) Adherence Questionnaire Score
Periodo de tiempo: 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.
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Post- Operative Visit (Day 36)
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Aspirin (ASA) Self-Efficacy Scale Score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Deborah Wittig-Wells, PhD, Emory University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
3 de octubre de 2017
Finalización primaria (Actual)
8 de marzo de 2019
Finalización del estudio (Actual)
8 de marzo de 2019
Fechas de registro del estudio
Enviado por primera vez
7 de agosto de 2017
Primero enviado que cumplió con los criterios de control de calidad
7 de agosto de 2017
Publicado por primera vez (Actual)
9 de agosto de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de octubre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
21 de octubre de 2019
Última verificación
1 de octubre de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB00094970
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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