Linking Self-Management and Primary Care for Diabetes 2 (LB2)
Linking Self-Management and Primary Care for Diabetes
This project is primarily a behavioral study. We employed a three-arm, patient-randomized practical effectiveness trial to evaluate the impact of two different interactive, multimedia self-management programs, relative to "enhanced" usual care. The two interventions will be (a) the revised program from our present study, based on our social-ecological theory and the 5 As self-management model, plus enhanced support (ASM+ES) that includes practical, but extensive, ongoing support and b) largely Automated Self-Management (ASM). These programs will be compared to a realistic "enhanced usual care" (UC) condition that will provide health risk appraisal feedback, control for computer interactions, and provide standardized advice on behavior change, but not the hypothesized key intervention processes of goal-setting, barriers identification, problem-solving, or social-environmental support. Patients will be randomized to conditions within clinic and will participate for 1 year.
The proposed project will test the effectiveness of a practical, automated-based intervention for primary care patients to facilitate dietary and physical activity practices, and medication-taking. Analyses will focus on primary outcomes of (a) dietary, physical activity, medication-taking outcomes, and (b) the UKPDS risk equation as well as secondary quality-of-life, patient-activation, and patient care outcomes (Specific Aim #2). Using the RE-AIM measures, we will analyze the reach, effectiveness, adoption, implementation, and maintenance of the intervention programs (Specific Aim #3), and also factors related to program implementation, linkage to primary care, and program success with emphasis on cost, cost-effectiveness, and mediators and moderators of outcomes such as social-environment support (Aim #4).
Primary hypotheses:
- That the Automated Intervention received by Automated self-management (ASM) condition and ASM plus enhanced support conditions (ASM+ES) will be superior to usual care on the primary outcomes.
- That the ASM+ES condition will be superior to the ASM alone condition on primary outcomes at the 12-month follow-up.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Colorado
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Denver, Colorado, Estados Unidos, 80237-8066
- Kaiser Permanente of Colorado
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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:
- Inclusion criteria:
- being 25-75 years of age,
- live independently,
- have a telephone,
- are able to read in either English or Spanish,
- able to access the Internet at least twice per week
- are capable of providing informed consent,
- have been diagnosed with type 2 diabetes for at least 1 year
- are overweight (BMI ≥ 25), and
- have at least one additional UKPDS equation risk factor (i.e., high lipids, hypertension, HbA1c, or smoking)
Exclusion Criteria:
- Exclusion criteria:
- Suffering dementia or active psychosis,
- Being on end-stage dialysis,
- or predicted to live fewer than 2 years
- Being institutionalized.
- Pregnant women - women with gestational diabetes will not be enrolled, because there needs are quite different, but we won't specifically exclude women who are pregnant AND otherwise eligible, since we do acknowledge that it's possible that someone may be unaware that they are pregnant at the time of enrollment, or may become pregnant during the study, and that this will not affect their continued participation.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Computer Assisted Self Management plus Social Support
an interactive, automated self-management (ASM) program that uses web and interactive voice recognition (IVR) media combined with enhanced support in the form of group Diabetes Care Management visits and live follow up phone calls from Diabetes Care Managers
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Computer Assisted Self Management plus Social Support
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Sem intervenção: Usual care
will receive a health-risk appraisal, interactive CD-ROM program that provides standardized advice on behavior change, but not the hypothesized key intervention processes of goal setting, barriers identification, problem solving, or social environmental support.
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Experimental: Computer Assisted Self Management
An interactive, automated self-management (ASM) program that uses web and interactive voice recognition (IVR) media.
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Computer Assisted Self Management using and interactive, automated self-management program that uses web and interactive voice recognition (IVR) media
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Improvement in health behaviors (e.g., dietary patterns, physical activity, medication taking) and biologic outcomes (HbA1c, lipid ratio, blood pressure, and smoking status).
Prazo: Baseline, 4 months and 12 months
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Baseline, 4 months and 12 months
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Diabetes-specific quality of life (Diabetes Distress Scale), patient activation (PAM scale), and perceived social-environmental support (the Chronic Illness Resources Survey) at 4- and 12-month follow-ups.
Prazo: 4 and 12 months
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4 and 12 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Russell E Glasgow, PhD, Kaiser Permanente
Publicações e links úteis
Publicações Gerais
- Glasgow RE, Nelson CC, Strycker LA, King DK. Using RE-AIM metrics to evaluate diabetes self-management support interventions. Am J Prev Med. 2006 Jan;30(1):67-73. doi: 10.1016/j.amepre.2005.08.037.
- Estabrooks PA, Nelson CC, Xu S, King D, Bayliss EA, Gaglio B, Nutting PA, Glasgow RE. The frequency and behavioral outcomes of goal choices in the self-management of diabetes. Diabetes Educ. 2005 May-Jun;31(3):391-400. doi: 10.1177/0145721705276578.
- Glasgow, R.E., Nutting, P.A. (2004) Diabetes. Handbook of Primary Care Psychology. L. Haas (Editor) Oxford University Press, New York, pp 299-319.
- Glasgow RE, Bull SS, Piette JD, Steiner JF. Interactive behavior change technology. A partial solution to the competing demands of primary care. Am J Prev Med. 2004 Aug;27(2 Suppl):80-7. doi: 10.1016/j.amepre.2004.04.026.
- King, D.K., Glasgow, R.E. (2004) Self-management of Type 2 Diabetes: Key Issues, Evidence-Based Recommendations, and Future Directions. In: Best Practices in the Behavioral Management of Chronic Disease, J. Trafton & William Gordon (Eds.). Institute for Disease Management, Los Altos, CA, Vol 2, Chapter 9.
- King DK, Estabrooks PA, Strycker LA, Toobert DJ, Bull SS, Glasgow RE. Outcomes of a multifaceted physical activity regimen as part of a diabetes self-management intervention. Ann Behav Med. 2006 Apr;31(2):128-37. doi: 10.1207/s15324796abm3102_4.
- Glasgow RE, Christiansen SM, Kurz D, King DK, Woolley T, Faber AJ, Estabrooks PA, Strycker L, Toobert D, Dickman J. Engagement in a diabetes self-management website: usage patterns and generalizability of program use. J Med Internet Res. 2011 Jan 25;13(1):e9. doi: 10.2196/jmir.1391.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (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
- 2R01DK035524-21 (Concessão/Contrato do NIH dos EUA)
- R01DK035524 (Concessão/Contrato do NIH dos EUA)
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Ensaios clínicos em CASM +
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University of California, San FranciscoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)ConcluídoDiabetes tipo 2Estados Unidos
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University of California, San DiegoNovartisConcluídoDermatite atópicaEstados Unidos