The Effectiveness of Interactive Nursing Education Program Through Health Belief Model Based and Informative Technology-assisted on Atrial Fibrillation Patients Receiving Oral Anticoagulant
22 de noviembre de 2021 actualizado por: Chang Gung Memorial Hospital
The Effectiveness of Interactive Nursing Education Program Through Health Belief Model Based and Informative Technology-assisted on Atrial Fibrillation Patients Receiving Oral Anticoagulant: A Randomized Control Trial
This study examined patients on taking oral anticoagulants (OACs) are often prescribed for Atrial fibrillation (AFib) to determine the effectiveness of a multiple interactive health education program, which was developed based on the health belief model (HBM) and incorporated information technologies.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
A randomized controlled study was conducted on the cardiology outpatients.
The patients were recruited through purposive sampling.
The participants had been diagnosed with AFib and were receiving OACs.
The participants were divided according to the blocks of clinic hours and assigned randomly to the experimental group or control group.
The control variables involved demographic characteristics and medical history.
The dependent variables and corresponding research instruments were medication knowledge and health beliefs, medication satisfaction and quality of life (QoL).
Other than the medication knowledge questionnaire, which was assessed monthly, all the measurement instruments were applied twice: first in a pretest, and again in a posttest administered at the third month.
The interventions administered to the experimental group were one-on-one instruction and HBM-driven strategies, health information technology system, monthly telephone follow-ups, and providing medication cards.
The participants in the control group only received brochure and medication cards.
Tipo de estudio
Intervencionista
Inscripción (Actual)
150
Fase
- No aplica
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
20 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- diagnosis of Atrial Fibration by a physician and taking oral anticoagulant as treatment
- 20years old or older
- clear consciousness for communication
- willingness to participate in research.
Exclusion Criteria:
- can not communicate clearly
- without willingness to participate in research
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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Educational group
The interventions administered to the experimental group were one-on-one instruction and Health Brief Model (HBM)-driven strategies, health information technology system, monthly telephone follow-ups, and providing medication cards.
|
The interventions administered to the experimental group were one-on-one instruction and Health Belief Model (HBM)-driven strategies, health information technology system, monthly telephone follow-ups, and providing medication cards.
Patient education related oral anticoagulant: each subject in the experimental group was taught individually according to investigators' App in the outpatient department (OPD) by researchers.
Every months, participants received a follow-up phone call to clarify any questions related to the knowledge of anticoagulants.
The contents of the teaching material consisted of: the purpose of taking anticoagulant, side effects, adjustments to daily diet, and precautions (i.e.how to take medication safely, interaction between foods and medicine, prevention and checking of signs and symptoms of bleeding).
The control group received the brochure and medical card after pretest and routine care in the OPD.
All participants completed posttest at 3-month follow-up.
|
|
Sin intervención: Control group
Patients in the control group only received brochure and medication cards.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The change of "medication knowledge of anticoagulants"
Periodo de tiempo: medication knowledge of anticoagulants was assessed at baseline, change from baseline medication knowledge of anticoagulants at 2 months, and change from baseline medication knowledge of anticoagulants at 3 months
|
There were 11 questions related to knowledge of anticoagulants designed by investigators' research team.
The range of scores was 0-22.
The higher the score, the better the participants' knowledge of anticoagulants was.
|
medication knowledge of anticoagulants was assessed at baseline, change from baseline medication knowledge of anticoagulants at 2 months, and change from baseline medication knowledge of anticoagulants at 3 months
|
|
The change of "health beliefs of anticoagulants"
Periodo de tiempo: health beliefs of anticoagulants were assessed at baseline, and change from baseline health beliefs of anticoagulants at 3 months
|
There were 22 questions related to health beliefs of anticoagulants designed by investigators' research team.
The range of scores was 0-88.
The higher the score, the better the participants' health beliefs was.
|
health beliefs of anticoagulants were assessed at baseline, and change from baseline health beliefs of anticoagulants at 3 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The change of "medication satisfaction of anticoagulants"
Periodo de tiempo: medication satisfaction of anticoagulants was assessed at baseline, and change from baseline medication satisfaction of anticoagulants at 3 months
|
There were 26 questions related to medication satisfaction of anticoagulants (Duke Anticoagulation Satisfaction Scale, DASS).
The range of scores was 1-182.
The lower the score, the better the participants' medication satisfaction was.
|
medication satisfaction of anticoagulants was assessed at baseline, and change from baseline medication satisfaction of anticoagulants at 3 months
|
|
The change of "quality of life for patients taking anticoagulants"
Periodo de tiempo: quality of life for patients taking anticoagulants was assessed at baseline, and change from baseline quality of life for patients taking anticoagulants at 3 months
|
There were 12 questions related to quality of life for patients taking anticoagulants (Short Form-12, SF-12).
The range of scores was 0-100 transferred in each question.
The higher the score, the better the participants' quality of life was.
|
quality of life for patients taking anticoagulants was assessed at baseline, and change from baseline quality of life for patients taking anticoagulants at 3 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Yu-Hsia Tsai, Chang Gung University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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)
1 de diciembre de 2014
Finalización primaria (Actual)
28 de febrero de 2018
Finalización del estudio (Actual)
28 de febrero de 2018
Fechas de registro del estudio
Enviado por primera vez
23 de julio de 2021
Primero enviado que cumplió con los criterios de control de calidad
22 de noviembre de 2021
Publicado por primera vez (Actual)
6 de diciembre de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de diciembre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
22 de noviembre de 2021
Última verificación
1 de julio de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 103-5623B
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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