Mobile Health Application for Diabetes
17 de octubre de 2019 actualizado por: Scott Sittig, University of South Alabama
Incorporating Behavioral Trigger Measures Into a Mobile Health (mHealth) App Design for Chronic Disease Management: Pilot Study in Diabetes
Creation of a mobile health application for individuals with type II diabetes.
This application was designed to improve knowledge, self-efficacy and self-care.
The application delivered educational material and provided push notifications (messages).
It also allowed for the participants to key in blood glucose levels, carbohydrate consumption and daily exercise.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
capABILITY (the mobile health application) was designed to cover three main diabetes content areas which the investigators call modules: diet (module 1), exercise (module 2) and self-management (module 3) (i.e. medication adherence, glucose monitoring). The length of the study was 9 weeks in duration with three weeks of content per module. Within each module new material was delivered each week through capABILITY. Essentially, every Monday started a new week's worth of educational material that was intended to last until Sunday. Each participant was randomly assigned to either the control group (no triggers), spark trigger group or facilitator trigger group. At the beginning of each module the participants would be randomly assigned to one of the three aforementioned classification groups (this was a 2-Factor Cross-Over Design).
The investigators utilized the Perceived Diabetes Self-Efficacy Scale , Diabetes Knowledge Test developed by Michigan University, and the Summary of Diabetes Self-Care Activities Measures scale (SDSCA) . All the participants completed the perceived diabetes self-efficacy scale along with the knowledge test and SDSCA Pre/Post intervention. In addition, the participants answered one self-efficacy, knowledge, self-care and goal question at the conclusion of each week within capABILITY.
Tipo de estudio
Intervencionista
Inscripción (Actual)
20
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
21 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Must be at least 21 years of age or older
- Current diagnosis of type II diabetes
- Must have access to a smartphone and daily internet (WiFi)
Exclusion Criteria:
- Anyone with gestational diabetes
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 Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Control
This was the control group for the messaging component of the study (push notifications).
These participants only received the mobile health application called capABILITY without messages.
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Otro: Facilitator Message Group
This group of participants received the mobile health application called capABILITY and received three facilitator messages per week.
Facilitator messages are designed to help people who lack ability to do something.
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All participants utilized the designed capABILITy application.
The application consisted of education material and persuasive messaging.
There were two types of messaging components named facilitators and sparks.
This created three groups consisting of: control, facilitators and sparks.
Participants spent 1 month in each group (total duration of the study was three months).
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Otro: Spark Trigger Group
This group of participants received the mobile health application called capABILITY and received three spark messages per week.
Spark messages are designed to help people who lack ability to do something.
|
All participants utilized the designed capABILITy application.
The application consisted of education material and persuasive messaging.
There were two types of messaging components named facilitators and sparks.
This created three groups consisting of: control, facilitators and sparks.
Participants spent 1 month in each group (total duration of the study was three months).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
20 participants baseline self-efficacy score will be measured at baseline and after the utilization (9 weeks) of the mHealth application capABILITY.
Periodo de tiempo: 9 Weeks
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Participants completed the Perceived Diabetes Self-Management Scale at baseline and post intervention to measure their self-efficacy.
The measure (scale) consists of eight questions ranging from strongly disagree (1) to strongly agree (5).
All items are scored so that high scores equals higher perceived self-efficacy.
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9 Weeks
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20 participants baseline diabetes knowledge score will be measure at baseline and after the utilization (9 weeks) of the mHealth application capABILITY.
Periodo de tiempo: 9 Weeks
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Participants completed the Brief Diabetes Knowledge Test (DKT2) at baseline and post intervention to measure their overall type II diabetes knowledge.
The measure (scale) consists of twenty- three multiple choice knowledge questions.
The score was calculated based on the number of questions answered correctly with higher scores representing a higher knowledge level.
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9 Weeks
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20 participants baseline diabetes self-management score will be measured at baseline and after the utilization (9 weeks) of the mHealth application capABILITY.
Periodo de tiempo: 9 Weeks
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Participants completed the Summary of Diabetes Self-Care Activities Questionnaire at baseline and post intervention to measure their diabetes self-care.
The measure (scale) consists of twenty five questions ranging from a score of 1 (days per week) to 7 (days per week).
All items are scored so that high scores equals higher self-care.
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9 Weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Participants will login and use capABILITY quicker (time measured in seconds) after receiving a behavioral trigger message than those participants who don't receive a behavioral trigger.
Periodo de tiempo: 9 Weeks
|
Participants will engage quicker with capABILITY after they receive behavioral triggers (Sparks and Facilitators) than those participants who don't receive behavioral triggers.
Participants in the Spark and Facilitator groups received push messages (triggers) on Tuesday, Thursday and Saturday at 10:00 am.
Time was measured in seconds and the calculation was the time between push notification delivery (10:00am) and the participant login to capABILITY.
The smaller the number in seconds the quicker the login time from push notification delivery.
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9 Weeks
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Participants who receive a Spark trigger message will login and use capABILITY quicker (time measured in seconds) than those participants who receive Facilitator trigger message.
Periodo de tiempo: 9 Weeks
|
Participants will engage quicker with capABILITY after they receive Spark trigger messages than those who receive a Facilitator trigger message.
Participants in the Spark and Facilitator groups received push messages (triggers) on Tuesday, Thursday and Saturday at 10:00 am.
Time was measured in seconds and the calculation was the time between push notification delivery (10:00am) and the participant login to capABILITY.
The smaller the number in seconds the quicker the login time from push notification delivery.
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9 Weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Scott Sittig, PhD, University of South Alabama
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 enero de 2015
Finalización primaria (Actual)
1 de enero de 2017
Finalización del estudio (Actual)
1 de abril de 2017
Fechas de registro del estudio
Enviado por primera vez
8 de octubre de 2019
Primero enviado que cumplió con los criterios de control de calidad
17 de octubre de 2019
Publicado por primera vez (Actual)
18 de octubre de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de octubre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
17 de octubre de 2019
Última verificación
1 de octubre de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1122 (Jian-jun Li)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
The participant data from this study will not be shared with other researchers.
Findings of the study will be published however.
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
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