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- Ensaio Clínico NCT00786344
USC Well Elderly Study 2
Health Mediating Effects of the Well Elderly Program
Visão geral do estudo
Descrição detalhada
Previous theory and research implicates participation in meaningful activity as an important factor in enhancing older adults' health-related quality of life. Consistent with this emphasis, a previous R01 grant completed by our study group demonstrated that an activity-based intervention (the Well Elderly Intervention) reduced declines in a wide variety of health-related parameters among low income, ethnically diverse elders. In the current four-year project, we attempted to replicate our previous result while simultaneously examining the mediating mechanisms responsible for its positive effects. The outcomes of this study will provide important new information about the process events by which activity-based lifestyle interventions influence key aging outcomes.
In the study, 460 ethnically diverse elders were recruited from 21 sites in the greater Los Angeles area, and participated in a randomized experiment containing a semi-crossover design component. The sites included 9 senior citizen centers (Culver City Senior Center, Estelle Van Meter Multipurpose Center, Hawthorne Senior Center, Hollywood Senior Multipurpose Center, Joslyn Adult Center - Burbank, Lennox Senior Center, Long Beach Senior Center, St. Barnabas Senior Center, and Slauson Recreation Center), as well as 12 senior residences (Casa TELACU, Covenant Manor, Eucalyptus Park, George McDonald Court, Motion Picture and Television Fund, Pilgrim Towers East, Regent Plaza, TELACU Del Rio, TELACU Manor, TELACU Senior Housing, TELACU Terrace, and Ward Villas).
Within either the first or second six-month phase of their study involvement, each subject received a lifestyle-based intervention designed to improve a variety of aging outcomes. At 4-5 points in time over an 18-24 month interval, elders completed assessments of healthy activity, coping, social support, perceived control, stress-related biomarkers, perceived physical health, psychosocial well-being, and cognitive functioning to test the efficacy of the intervention and document the process mechanisms responsible for its effects.
The study has three long-term objectives. First, it will lead to more effective health care services for our nation's rapidly growing elderly population, thereby fulfilling a major policy priority for older adults, namely, preventing declines in their health and independence. Second, it will generate new information regarding how activity influences aging outcomes. Although previous research has shown that activity patterns consistently relate to important aging outcomes, little is known about how the psychological and biological changes that stem from activities combine to promote successful aging. This study will reduce this knowledge gap. Third, due to the significant ethnic diversity at the study sites, the project will produce results that generalize to minority elders. This outcome is important due to the increasing ethnic diversity of our nation's aging population.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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California
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Los Angeles, California, Estados Unidos, 90089-9003
- University of Southern California
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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:
- Fluent speaker of English or Spanish
- Living in the community
Exclusion Criteria:
- Hospitalized
- Living in nursing home
- Mental confusion/dementia
- Participation in the first Well Elderly Study
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Lifestyle Redesign
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For a six-month period, each elder participated in weekly 2-hour sessions involving groups of size 8-10, and also received up to 10 hours of individualized treatment over this time period. Modular treatment units included the following content areas: (1) Introduction to the Power of Activity; (2) Aging, Health, and Activity; (3) Transportation; (4) Safety; (5) Social Relationships; (6) Cultural Awareness; (7) Finances; and (8) Integrative Summary: Lifestyle Redesign Notebook. The methods of program delivery consisted of didactic presentation, peer exchange, direct experience, and personal exploration. Treatment materials were translated into Spanish and culturally adapted for approximately 15% of the subjects.
Outros nomes:
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Sem intervenção: No Treatment Control
The no treatment control arm did not receive the intervention during the first six-month period.
However the intervention, which has been proven to be beneficial, was administered to the control arm immediately following the 6 month assessment.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Perceived Physical Health
Prazo: within 1 month of completion of intervention
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within 1 month of completion of intervention
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Psychosocial Well-Being
Prazo: within 1 month of completion of intervention
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within 1 month of completion of intervention
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Cognitive Functioning
Prazo: within 1 month of completion of intervention
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within 1 month of completion of intervention
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Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Healthy Activity
Prazo: within 1 month of completion of intervention
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within 1 month of completion of intervention
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Active Coping
Prazo: within 1 month of completion of intervention
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within 1 month of completion of intervention
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Perceived Control
Prazo: within 1 month of completion of intervention
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within 1 month of completion of intervention
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Social Support
Prazo: within 1 month of completion of intervention
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within 1 month of completion of intervention
|
Positive Reinterpretation-Based Coping
Prazo: within 1 month of completion of intervention
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within 1 month of completion of intervention
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Stress-Related Biomarkers
Prazo: within 1 month of completion of intervention
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within 1 month of completion of intervention
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Florence A Clark, PhD, OTR/L, University of Southern California
Publicações e links úteis
Publicações Gerais
- Leland NE, Fogelberg D, Sleight A, Mallinson T, Vigen C, Blanchard J, Carlson M, Clark F. Napping and Nighttime Sleep: Findings From an Occupation-Based Intervention. Am J Occup Ther. 2016 Jul-Aug;70(4):7004270010p1-7. doi: 10.5014/ajot.2016.017657.
- Clark F, Jackson J, Carlson M, Chou CP, Cherry BJ, Jordan-Marsh M, Knight BG, Mandel D, Blanchard J, Granger DA, Wilcox RR, Lai MY, White B, Hay J, Lam C, Marterella A, Azen SP. Effectiveness of a lifestyle intervention in promoting the well-being of independently living older people: results of the Well Elderly 2 Randomised Controlled Trial. J Epidemiol Community Health. 2012 Sep;66(9):782-90. doi: 10.1136/jech.2009.099754. Epub 2011 Jun 2. Erratum In: J Epidemiol Community Health. 2012 Nov;66(11):1082.
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
Outros números de identificação do estudo
- 5R01AG021108-04 (Concessão/Contrato do NIH dos EUA)
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Ensaios clínicos em Lifestyle Redesign
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Ullevaal University HospitalThe Royal Norwegian Ministry of Health; The Norwegian Women´s Public Health...Desconhecido