Technology-Assisted Stepped Care Study (TASC Phase 3)
9 de marzo de 2022 actualizado por: Children's Hospital Medical Center, Cincinnati
Technology Assisted Stepped Care (TASC): Phase 3
The overall goal of this project is to demonstrate the feasibility, implementation, and preliminary efficacy of a technology-assisted stepped care (TASC) adherence-promotion intervention in adolescents with asthma.
This is the third phase (Phase 3) of a three-phase project to test the preliminary efficacy of a technology-assisted stepped care (TASC) intervention.
In Phase 1, we developed the intervention using patient and provider feedback from focus groups.
In Phase 2 we refined the developed intervention by having five adolescents from the focus groups test the intervention for feasibility.
In this third phase, we will enroll up to 50 adolescents to pilot-test the refined intervention for preliminary efficacy.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Up to fifty adolescents with asthma will be enrolled in an open label pilot trial of the TASC adherence-promotion intervention for a duration of twelve months.
First, participants will complete baseline questionnaires related to demographic, and clinical predictors of adherence and asthma and a 4 week run-in phase to assess baseline adherence using electronic inhaler monitoring with a cellphone that is provided to them.
Following the run-in period, all participants will receive Step 1 of the TASC intervention for a minimum of 4 weeks.
Step 1 (Information) will include electronic educational information related to asthma symptoms and triggers, attacks, self-monitoring, treatments, action plans, and automated text message medication reminders.
Following the initial four weeks of Step 1, adherence will be evaluated and a rate of less than 68% will serve as the cause for "stepping up" to the next level of the intervention.
Adherence checks will continue to occur every four weeks for the duration of the study and adherence <68% will prompt movement from one level of treatment to the next.
Participants may remain at a treatment level for more than four weeks and may complete 1, 2, or 3 interventions steps during the 5 month study depending on the adolescent's adherence.
Step 2 (Motivation) will include electronic monitoring of adherence and personally tailored feedback via text messages.
Adolescents will be given access to the adherence tracking cellphone app and graphs of their inhaler adherence.
Adolescents will also receive brief, personalized text messages that provide supportive motivation and directive, tangible actions.
Step 3 (Behavioral) will include problem-solving telehealth intervention with a trained clinician.
Four telehealth sessions individually tailored to the unique needs and barriers of the adolescent will be provided.
The primary outcome measure will be electronically-monitored adherence assessed at post-treatment.
Secondary outcomes include asthma severity as well as process evaluation questions and quantitative measures of feasibility, acceptability, and satisfaction to demonstrate implementation.
Participants will remain in the study for an additional 7 months after they complete month 5 of the study.
For the remaining 7 months, participants will be randomized to one of two booster session patterns with the goal to improve inhaler adherence.
The statistician will make the randomization schedule and the principle investigator will maintain the randomization schedule.
Two different booster patterns are being used to test which pattern will be most effective.
The first booster session pattern will include booster sessions at the end of month 6, 8, and 12.
The second booster session pattern will include booster sessions at the end of month 6, 7, 8, 10, and 12. Booster sessions will review content provided during the intervention and the intervention delivery method will be consistent with the participants final intervention step.
Participants will also continue to complete monthly check-ins with the study coordinator to complete the Composite Asthma Severity Index, the Asthma Control Test, and a spirometry test.
Tipo de estudio
Intervencionista
Inscripción (Actual)
40
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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Ohio
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Cincinnati, Ohio, Estados Unidos, 45229
- Cincinnati Children's Medical 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
12 años a 18 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patient age between 12-18 years
- Patient is diagnosed with severe-persistent or moderate-persistent asthma per NAEPP asthma guidelines
- Patient is prescribed at least one daily inhaled controller medication or a daily combination inhaled corticosteroid and long-acting beta-agonist and a beta-agonist bronchodilator
- English fluency for patient, caregiver, and clinician
Exclusion Criteria:
- Significant cognitive deficits that may interfere with comprehension per medical team or chart review.
- Diagnosis of serious mental illness (e.g., schizophrenia)
- Diagnosis of pervasive developmental disorder
- Active chronic disease apart from asthma or allergic disease (e.g. Bronchiectasis)
- Patient receives school administered daily controller medication at the time of the enrollment visit
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: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Intervención TASC
Todos los participantes reciben el Paso 1 de la intervención.
Los participantes que tengan una adherencia inferior o al 68 % pasarán al Paso 2 o al Paso 3 después del tercer o cuarto mes del estudio.
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El paso 1 de la intervención incluye materiales educativos relacionados con el asma.
El paso 2 incluye el seguimiento electrónico de la adherencia y una intervención de mensajes de texto adaptada personalmente al participante.
El paso 3 incluye sesiones de telesalud para resolver problemas con un médico capacitado.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Electronic Monitoring
Periodo de tiempo: 12 months
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The Propeller Health monitoring system includes a Bluetooth enabled sensor that attaches to the patient's inhaler.
This sensor records every dose, or "puff", the patient takes and sends it to a corresponding online database that is accessible to study staff.
Participants will be given this sensor at baseline.
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12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cuestionario de viabilidad/aceptabilidad
Periodo de tiempo: 5 meses
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Se entregará a los participantes una medida de 5-31 ítems de formato, contenido, duración, habilidades y aceptabilidad de la intervención en forma de cuestionario al final de cada paso y al final del estudio.
La sección de factibilidad está en una escala de 0 a 4, siendo 0 lo peor y 4 lo mejor.
El cuestionario de aceptabilidad está en una escala de 'Nada en absoluto' a 'Mucho', siendo 'Nada en absoluto' lo peor y 'Mucho' lo mejor.
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5 meses
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Escala de usabilidad del sistema
Periodo de tiempo: 5 meses
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Se entregará a los participantes una escala Likert de 10 elementos que ofrece una visión global de la usabilidad en forma de cuestionario al final de cada paso y al final del estudio.
La escala va de 'Totalmente en desacuerdo' a 'Totalmente de acuerdo, con la mitad de los ítems calificados al revés.
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5 meses
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Lung Function Assessment
Periodo de tiempo: Baseline assessment and then once a month for 12 months
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The mobile spirometer records multiple parameters of the patient's lung function including forced expiratory volume, peak expiratory flow, forced vital capacity, and forced expiratory flow.
The spirometer sends the values to the corresponding mobile phone application, Propeller Health, which is directly accessible to the patient.
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Baseline assessment and then once a month for 12 months
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Composite Asthma Severity Index (CASI)
Periodo de tiempo: Baseline assessment and then once a month for 12 months
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The participants' composite asthma severity index score will be calculated through the TreatSmart program.
TreatSmart will be used to determine the participant's symptom burden, health care utilization, systemic corticosteroid use, and current medication use to determine the level of asthma severity/control the participant has.
The program also makes an initial treatment recommendation based on the National Asthma Education and Prevention Program (NAEPP asthma guidelines).
Individuals are placed in Step 1 through Step 6 depending on the strength and frequency of their inhaled corticosteroid (1 being low dose and 6 being a high dose).
In addition, individuals are categorized as very poorly controlled, not well controlled, or well controlled based on how frequently they have had asthma symptoms or used their rescue inhaler, gone to the hospital or urgent care, or received steroids for asthma symptoms.
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Baseline assessment and then once a month for 12 months
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Asthma Control Test (ACT)
Periodo de tiempo: Baseline assessment and then once a month for 12 months
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The ACT will be used as a measure of disease severity in this study.
The ACT is a 5-question scoring tool designed for patients with asthma who are 12 years and older.
The questions ask the patient to rate their asthma severity, symptom frequency, control, and inhaler use on a scale of 1-5.
The total score is calculated by the sum of each response, which determines how well-controlled the patient's asthma is on a scale from 5-25.
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Baseline assessment and then once a month for 12 months
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Attendance/Participation rates
Periodo de tiempo: 12 months
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Participation rates will be measured 3 different ways.
The first measure will be how often participants accessed the electronic material (educational materials and/or Propeller Health app), the second measure will be how many responses to directive text messaging were received, and the third measure will be attendance to the telehealth sessions.
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12 months
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Acceptability of Intervention Measure (AIM)
Periodo de tiempo: At 5 months
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A 4 item measure of participants' belief that the intervention is acceptable will be given at the end of the study.
Participants respond to each statement on a 5 point Likert scale (1= Completely Disagree, 5= Completely Agree).
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At 5 months
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Intervention Appropriateness Measure (IAM)
Periodo de tiempo: At 5 months
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A 4 item measure of participants' perception that the intervention is appropriate will be given at the end of the study.
Participants respond to each statement on a 5 point Likert scale (1= Completely Disagree, 5= Completely Agree).
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At 5 months
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Feasibility of Intervention Measure (FIM)
Periodo de tiempo: At 5 months
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A 4 item measure of participants' belief that the intervention is feasible will be given at the end of the study.
Participants respond to each statement on a 5 point Likert scale (1= Completely Disagree, 5= Completely Agree).
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At 5 months
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Treatment Fidelity
Periodo de tiempo: 12 months
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Treatment fidelity needed for the intervention will be assessed.
Treatment fidelity will be assessed through fidelity checklists created specifically for each intervention session.
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12 months
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Time Needed for Intervention
Periodo de tiempo: 12 months
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Sessions will be timed and the number of weeks to complete the session will be tracked to determine the average length of time needed for the intervention.
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12 months
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Perceived Characteristics of Intervention Scale
Periodo de tiempo: At 12 months
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19 item measure of interventionist views toward the study intervention.
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At 12 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Behavior Assessment System for Children-Third Edition, Self-report of Personality (BASC-3-SRP-A
Periodo de tiempo: Baseline assessment and at 5 months
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The BASC-3 is a widely used, reliable (α= 0.94 - 0.96 , test-retest r= 0.81 -0.82), and valid inventory to assess emotional and behavioral symptoms in adolescents and young adults (ages 13-21).
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Baseline assessment and at 5 months
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Adolescent Barriers to Medication Scales (AMBS)
Periodo de tiempo: Baseline Assessment
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The AMBS is an 18-item validated measure of perceived barriers to medication adherence in adolescents.
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Baseline Assessment
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Technology-based Experience of Need Satisfaction- Interface questionnaire (TENS-Interface)
Periodo de tiempo: Baseline assessment and then at 2 months
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A 15- item measure of participant's competence, autonomy, and relatedness in using technology.
Participants rate their level of agreement to each statement on a 5- point Likert scale (1= Do Not Agree, 5= Strongly Agree).
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Baseline assessment and then at 2 months
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Autonomy and Competence in Technology Adoption Questionnaire (ACTA)
Periodo de tiempo: Baseline Assessment
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A 10-item measure of why people adopt use of a technology (i.e.
download an app, register with a website, purchase a wearable device, etc.).Participants respond to self-regulation statements on a scale of 1 to 5, 1 being 'not at all true' and 5 being 'very true.'
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Baseline Assessment
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Technology-based Experience of Need Satisfaction- Task questionnaire (TENS- Task)
Periodo de tiempo: Baseline assessment and then at 2 months
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An 8-item measure of participant's competence, autonomy, and relatedness in managing their asthma using technology.
Participants rate their level of agreement to each statement on a 5- point Likert scale (1= Do Not Agree, 5= Strongly Agree).
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Baseline assessment and then at 2 months
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Technology Effects on Need Satisfaction in Life (TENS- Life)
Periodo de tiempo: Baseline assessment and then at 2 months
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The TENS-Life is a 10- item measure of the extent to which a user perceives that the use of a particular technology has had an influence on the satisfaction of basic psychological needs in their life.
Participants rate their level of agreement to each statement on a 5- point Likert scale (1= Do Not Agree, 5= Strongly Agree).
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Baseline assessment and then at 2 months
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Cuestionario de conocimientos
Periodo de tiempo: Evaluación de referencia
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Un cuestionario de 13 ítems que evalúa el conocimiento del individuo sobre los síntomas, los desencadenantes y los medicamentos del asma.
Los participantes califican su nivel de acuerdo con cada afirmación en una escala que va desde "Muy de acuerdo" hasta "Muy en desacuerdo".
Este cuestionario se completará en la visita inicial.
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Evaluación de referencia
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Cuestionario de dificultades
Periodo de tiempo: Evaluación de referencia
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Un cuestionario validado de 19 ítems que evalúa la tensión financiera de las personas dentro de un hogar.
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Evaluación de referencia
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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)
7 de diciembre de 2018
Finalización primaria (Actual)
20 de abril de 2021
Finalización del estudio (Actual)
20 de abril de 2021
Fechas de registro del estudio
Enviado por primera vez
8 de febrero de 2019
Primero enviado que cumplió con los criterios de control de calidad
19 de marzo de 2019
Publicado por primera vez (Actual)
21 de marzo de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de marzo de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
9 de marzo de 2022
Última verificación
1 de marzo de 2022
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- CIN001- {"TASC Phase 3"}
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
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