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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00448474
Development and Evaluation of A Mailed Arthritis Self-Management Program
Mail-Delivered Arthritis Self-Management Education -- Years 1, 2, Carryover
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Effective self-management education programs for persons with arthritis have been developed, delivered in various formats, and found effective. Because of limited resources, however, many state health departments have found dissemination difficult, particularly to vulnerable populations. Researchers at the University of North Carolina at Chapel Hill and Stanford University will develop an evidence-based mail-delivered arthritis self-management program (Arthritis Yes I Can) that is feasible for state health department use and that can be self-tailored to meet the needs of diverse populations. The study will be conducted in three phases.
During Phase One (Development) researchers will collaborate with CDC advisors, arthritis experts from state health departments, and Project consultants to develop the curriculum and compact disc (CD) and print materials for mail-delivery. We will base Arthritis Yes I Can on curricula of two evidence-based programs, the Arthritis Self Help Course (ASHC) and the Chronic Disease Self Management Program (CDSMP), and develop English and Spanish versions.
During Phase Two (Evaluation) we will utilize both a randomized pre-test post-test (four month) delayed treatment control group design and a longitudinal cohort design to evaluate program effectiveness. We will recruit 900 individuals, 300 African Americans, 300 other English speakers, and 300 Spanish speakers, who: 1. Have been diagnosed with osteoarthritis or rheumatoid arthritis, or meet CDC criteria for chronic joint symptoms; 2. Are at least 18 years of age; and 3. Are able to complete informed consent, enrollment forms, and interviews/questionnaires. In addition, participants must not have participated in a previous arthritis self-management program and have access to a CD player. They must be willing to commit 8-12 hours of self-study over 4-6 weeks. We will use multiple recruitment methods, emphasizing collaboration with state and local health departments. We will measure: 1. Knowledge of Arthritis and Arthritis Self-Management, 2. Health-related Quality of Life (Self-reported Health, Pain, Disability, Fatigue, Activity Limitation, Health Distress, and Depression); 3. Health Care Utilization; 4. Self-Management Behaviors; and 5. Self-Efficacy for Arthritis Self-Management and Arthritis Helplessness. We will also evaluate participant satisfaction with mail delivery, and determine the relative success of all recruitment efforts.
If the intervention is found effective in Phase Two, we will offer guidance to the Arthritis Program of the Centers for Disease Control and Prevention in adopting and distributing Arthritis Yes I Can (Phase Three, Dissemination).
Tipo de estudo
Inscrição
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- University of North Carolina at Chapel Hill
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Report MD diagnosis of osteoarthritis or rheumatoid arthritis, or meet CDC criteria for chronic joint symptoms
- Are at least 18 years of age
- Are able to complete informed consent, enrollment forms, and interviews/questionnaires
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Educacional/Aconselhamento/Treinamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
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Health-related Quality of Life (Self-reported Health, Pain, Disability, Fatigue, Activity Limitation, Health Distress)
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Health Care Utilization
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Self-Management Behaviors
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Self-Efficacy for Arthritis Self-Management
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jean Goeppinger, PhD, BSN, University of North Carolina, Chapel Hill
- Investigador principal: Kate Lorig, DrPH, BSN, Stanford University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão do estudo
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 (Estimativa)
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
- 05-1163-1-3
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