Texting Atopic Dermatitis Patients to Optimize Learning and EASI Scores (TADPOLES)
Visão geral do estudo
Descrição detalhada
Atopic dermatitis (AD) is a common, chronic, and debilitating disease that tends to present in children under age 2 and has a waxing and waning course. Poor adherence to treatment is the primary preventable contributor towards adverse outcomes such as infection, hospitalization, permanent disfigurement, and disruptions in normal childhood psychological development. The burden of care for these patients often falls upon parents, who may have difficulty incorporating the necessary daily treatments into the family's lifestyle. Thus, investigating ways of improving adherence could have a significant impact on a patient's long term prognosis and the family's ability to understand and adjust to the demands of AD.Text message reminders with embedded health literacy information have been shown to improve vaccination rates in children and caregivers have reported increased satisfaction with this means of communication.
This study aims to assess whether text message reminders with information about AD are an effective way to improve treatment adherence and provide disease specific information to caregivers of children with AD. The measure of AD severity will be the Eczema Area and Severity Index (EASI) score. Health literacy with regard to AD will be assessed via in-office survey.This study will involve children age 0-6 with newly diagnosed AD and their primary caregivers. The subjects will be randomized to standard care or text message reminder group. All study participants will be asked to complete a survey after their initial evaluation and after their follow up visit on the same day they are in the office. The text message group will receive text messages with information and treatment reminders. All participants will receive the standard of care with regard to AD.
If this study demonstrates that text message reminders can improve EASI scores in AD patients it could lead to a significant change in how these patients are managed. Fewer complications from episodic flares, infections, and other sequelae may lessen the burden of this disease for both patients and their caregivers. Text messaging is an inexpensive, noninvasive, and broadly applicable tool that is worth studying for the purpose of improving treatment adherence and disease literacy.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
New York
-
New York, New York, Estados Unidos, 10032
- Columbia University Medical Center, Department of Dermatology
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- New clinical diagnosis of atopic dermatitis
- New patient to Columbia University Medical Center, Department of Dermatology
- Caregiver has mobile that can send/receive text messages
Exclusion Criteria:
- Age over 7 years
- Caregiver is not fluent English speaker
- Those patients in which a definitive diagnosis of atopic dermatitis cannot be made
- Any individual who declines participation
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Text Message Intervention + Standard Care
Enrolled patients and their caregivers who are randomized to this group will receive the usual standard of care for atopic dermatitis patients treated at this institution as well as daily text messages with information about atopic dermatitis and treatment reminders.
1-2 times/week they will receive a message asking if they were able to complete their treatments in the last day.
They will respond with 1=yes, 2=no, 3= I have questions about the treatment.
Those who respond with 3 will be sent the contact information for the office.
No other communications will be sent through text messages.
Caregivers will take two in-office surveys: one upon enrollment, and one follow-up survey at the follow-up visit.
Patient EASI Score will be assessed by the pediatric dermatologist and initial and follow up exam.
|
Daily text messages with information about atopic dermatitis and treatment reminders.
|
|
Sem intervenção: Standard Care
Enrolled patients and their caregivers who are randomized to this group will receive the usual standard of care for atopic dermatitis patients treated at this institution.
They will not receive text messages.
Caregivers will take two in-office surveys: one upon enrollment, and one follow-up survey at the follow-up visit.
Patient EASI Score will be assessed by the pediatric dermatologist and initial and follow up exam.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
EASI Score
Prazo: Up to 6 weeks
|
Patient EASI Score (0-72) will be determined at initial and follow up exam.
Mean differences in EASI scores between arms will be assessed using t-tests since EASI scores are used to measure the severity of a patient's atopic dermatitis.
|
Up to 6 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patient Satisfaction
Prazo: Up to 6 weeks
|
The investigators will assess mean difference in reported satisfaction, as indicated on follow up survey, between arms using t-tests.
|
Up to 6 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Christine Lauren, MD, Columbia University
Publicações e links úteis
Publicações Gerais
- Sokolova A, Smith SD. Factors contributing to poor treatment outcomes in childhood atopic dermatitis. Australas J Dermatol. 2015 Nov;56(4):252-7. doi: 10.1111/ajd.12331. Epub 2015 Mar 29.
- Filanovsky MG, Pootongkam S, Tamburro JE, Smith MC, Ganocy SJ, Nedorost ST. The Financial and Emotional Impact of Atopic Dermatitis on Children and Their Families. J Pediatr. 2016 Feb;169:284-90.e5. doi: 10.1016/j.jpeds.2015.10.077. Epub 2015 Nov 23.
- Bass AM, Anderson KL, Feldman SR. Interventions to Increase Treatment Adherence in Pediatric Atopic Dermatitis: A Systematic Review. J Clin Med. 2015 Jan 27;4(2):231-42. doi: 10.3390/jcm4020231.
- Stockwell MS, Hofstetter AM, DuRivage N, Barrett A, Fernandez N, Vargas CY, Camargo S. Text message reminders for second dose of influenza vaccine: a randomized controlled trial. Pediatrics. 2015 Jan;135(1):e83-91. doi: 10.1542/peds.2014-2475.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- AAAQ7858
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Text messages
-
Fundació d'investigació Sanitària de les Illes...Ativo, não recrutandoDiabetes Mellitus, Tipo 2Espanha
-
University of Southern CaliforniaConcluído
-
Fundació d'investigació Sanitària de les Illes...Inscrevendo-se por conviteIntervenção de saúde móvel para prevenir diabetes mellitus tipo 2 (estudo de fase II) (preDIABETEXT)Estado pré-diabéticoEspanha
-
Taipei Medical UniversityConcluído
-
Fundació d'investigació Sanitària de les Illes...ConcluídoDiabetes Mellitus, Tipo 2Espanha
-
Boston UniversityNational Cancer Institute (NCI); Brown University; National Institutes of Health... e outros colaboradoresConcluído
-
Sunnybrook Health Sciences CentreCanadian Institutes of Health Research (CIHR); Ontario Neurotrauma FoundationConcluídoQuedas Acidentais | Equilíbrio musculoesqueléticoCanadá
-
VA Office of Research and DevelopmentConcluídoDependência de nicotinaEstados Unidos
-
Arizona State UniversityCalifornia Polytechnic State University-San Luis ObispoConcluídoAtividade física | Dorme | Comportamento Sedentário | Tempo de telaEstados Unidos