Technology-Assisted Stepped Care Study (TASC Phase 3)
9 de março de 2022 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
40
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45229
- Cincinnati Children's Medical Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
12 anos a 18 anos (Filho, Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Intervenção TASC
Todos os participantes recebem o Passo 1 da intervenção.
Os participantes que tiverem adesão abaixo ou em 68% avançarão para a Etapa 2 ou Etapa 3 após o terceiro ou quarto mês no estudo.
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A etapa 1 da intervenção inclui materiais educativos relacionados à asma.
O passo 2 inclui o monitoramento eletrônico da adesão e uma intervenção de mensagem de texto personalizada para o participante.
A etapa 3 inclui sessões de telessaúde para resolução de problemas com um clínico treinado.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Electronic Monitoring
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Questionário de Viabilidade/Aceitabilidade
Prazo: 5 meses
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Uma medida de 5-31 itens de formato, conteúdo, extensão, habilidades e aceitabilidade da intervenção será dada aos participantes na forma de um questionário no final de cada etapa e no final do estudo.
A seção de viabilidade está em uma escala de 0 a 4, sendo 0 o pior e 4 o melhor.
O questionário de aceitabilidade está em uma escala de 'Nada' a 'Muito', 'Nada' sendo o pior e 'Muito' sendo o melhor.
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5 meses
|
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Escala de Usabilidade do Sistema
Prazo: 5 meses
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Uma escala Likert de 10 itens dando uma visão global da usabilidade será dada aos participantes na forma de um questionário ao final de cada etapa e ao final do estudo.
A escala varia de 'Discordo totalmente' a 'Concordo totalmente, com metade dos itens pontuados inversamente.
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5 meses
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Lung Function Assessment
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Behavior Assessment System for Children-Third Edition, Self-report of Personality (BASC-3-SRP-A
Prazo: Baseline assessment and at 5 months
|
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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: Baseline assessment and then at 2 months
|
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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Questionário de Conhecimento
Prazo: Avaliação de linha de base
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Um questionário de 13 itens que avalia o conhecimento do indivíduo sobre os sintomas, gatilhos e medicamentos da asma.
Os participantes avaliam o seu nível de concordância com cada afirmação numa escala de “Concordo totalmente” a “Discordo totalmente”.
Este questionário será preenchido na visita inicial.
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Avaliação de linha de base
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Questionário de dificuldades
Prazo: Avaliação de linha de base
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Um questionário validado de 19 itens que avalia a tensão financeira dos indivíduos dentro de uma família.
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Avaliação de linha de base
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
7 de dezembro de 2018
Conclusão Primária (Real)
20 de abril de 2021
Conclusão do estudo (Real)
20 de abril de 2021
Datas de inscrição no estudo
Enviado pela primeira vez
8 de fevereiro de 2019
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de março de 2019
Primeira postagem (Real)
21 de março de 2019
Atualizações de registro de estudo
Última Atualização Postada (Real)
10 de março de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de março de 2022
Última verificação
1 de março de 2022
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- CIN001- {"TASC Phase 3"}
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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