DockTales for Chronic Pain
Evaluating Feasibility and Acceptability of DockTales for Chronic Pain
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This is a fully remote, randomized crossover pilot clinical trial designed to evaluate the feasibility and acceptability of DockTales among adults with chronic pain. Chronic pain is defined as pain lasting for more than 3 months. A total of up to 60 participants will be enrolled.
Participants will be randomized in a 1:1 ratio to one of two study sequences. Participants assigned to Sequence 1 will complete 2 weeks of DockTales use followed by 2 weeks of REDCap-based daily monitoring. Participants assigned to Sequence 2 will complete 2 weeks of REDCap-based daily monitoring followed by 2 weeks of DockTales use. All participants will complete both study conditions.
Participants will complete questionnaires at baseline, after the first 2-week period, and after the second 2-week period. These assessments will evaluate feasibility, acceptability, usability, burden, engagement, technical issues, participant preference, and exploratory pain and sleep-related outcomes. Some participants may also complete an optional remote semi-structured interview after finishing both study conditions.
The primary outcomes are feasibility and acceptability. Feasibility will be assessed through recruitment, retention, adherence, completion of DockTales use, completion of REDCap monitoring, missing data, and technical issues. Acceptability will be assessed through satisfaction, engagement, perceived usefulness, ease of use, burden, willingness to use DockTales again, and preference between DockTales and REDCap monitoring.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Yang Wang, PhD
- Número de telefone: 410-706-7824
- E-mail: yang.wang@umaryland.edu
Locais de estudo
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- University of Maryland Baltimore School of Nursing
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Investigador principal:
- Yang Wang, PhD
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Contato:
- Yang Wang
- Número de telefone: 410-706-7824
- E-mail: yang.wang@umaryland.edu
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Contato:
- Rachel Massalee, MS
- Número de telefone: 410-706-7824
- E-mail: rmassalee@umaryland.edu
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Age ( 18-88 years old)
- English speaker (written and spoken)
- Chronic pain for at least 3 months
- Smartphone/text messaging capability
Exclusion Criteria:
- Any personal history of mania, schizophrenia, or other psychoses
- Severe psychiatric condition (e.g. schizophrenia, bipolar disorders, autism) leading to hospitalization within the last 3 years.
- Pregnancy or breast feeding
- Impaired or uncorrected hearing
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Outro: DockTales first
This is a crossover-designed study with one arm of chronic pain participants.
All participants will complete both active (DockTales) and control (REDCap) interventions in a randomized sequence.
The first arm will complete 2 weeks of DockTales first, and 2 weeks of REDCap monitoring
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DockTales includes several core features:
The focus of the DockTales intervention is to support self-monitoring, reflection, engagement, and user experience among adults with chronic pain.
REDCap will be used to monitor daily symptoms and diaries from people with chronic pain.
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Outro: REDCap first
This is a crossover-designed study.
Participants in this arm will start with 2 weeks of REDCap monitoring, followed by 2 weeks of DockTales use
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DockTales includes several core features:
The focus of the DockTales intervention is to support self-monitoring, reflection, engagement, and user experience among adults with chronic pain.
REDCap will be used to monitor daily symptoms and diaries from people with chronic pain.
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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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Enrollment rate
Prazo: At the enrollment
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Enrollment rate: the proportion (%) of recruited participants who enrolled in the study.
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At the enrollment
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Retention rate
Prazo: End of Week 4
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Retention rate: the proportion (%) of enrolled participants who finished the study
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End of Week 4
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Module completion rate
Prazo: End of Week 4
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Module rate: the proportion (%) of completed modules in the DockTales app.
The DockTales app contains 1) daily monitoring module; 2) navigation map module; 3) AI avatar companion module; and 4) daily dairy module.
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End of Week 4
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Daily survey completion rate
Prazo: End of Week 4
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Module rate: the proportion (%) of completed daily surveys sent through DockTales and REDCap-based surveys.
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End of Week 4
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Levels of satisfaction
Prazo: End of Week 2 and Week 4
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Levels of satisfaction are assessed using a visual analogue scale ranging from 0 = not satisfied at all to 100 = extremely satisfied.
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End of Week 2 and Week 4
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Levels of enjoyment
Prazo: End of Week 2 and Week 4
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Levels of enjoyment are assessed using a visual analogue scale ranging from 0 = not enjoyed at all to 100 = extremely enjoyed.
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End of Week 2 and Week 4
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Levels of engagement
Prazo: End of Week 2 and Week 4
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Levels of engagement are assessed using a visual analogue scale ranging from 0 = not engaged at all to 100 = extremely engaged.
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End of Week 2 and Week 4
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HP-00119506
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Descrição do plano IPD
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