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A Rehabilitation Intervention for Amnestic Mild Cognitive Impairment

3 de dezembro de 2014 atualizado por: Melanie C Greenaway, Emory University

A Multicenter Rehabilitation Intervention for Amnestic Mild Cognitive Impairment

Mild Cognitive Impairment (MCI) is often an early manifestation of Alzheimer's disease (AD). The ability to identify MCI has led to hope that health prevention models might work in AD as they have in cancer and heart disease. Interventions which help sustain functioning in MCI may delay progression to a clinical AD diagnosis. To date, interventions aimed at maintaining functioning in MCI have been pharmacologic in nature. The efficacy of these medications in MCI is controversial, and those with MCI are also often interested in other activities they can do to manage their memory loss.

When an individual is noted to have memory difficulties or MCI, a recommendation is often given for the patient to begin taking notes/using a calendar to help with memory or do cognitively stimulating activities. However, there is currently little instruction about how/what specific activities one should do and how effective they may be. The overall goal of this pilot project is to refine delivery of the Memory Support System (MSS)as a formal compensatory program for memory loss in MCI. Enrollment and retention data will be carefully investigated across 6 week and 10 day intervention groups. The investigators will compare participant adherence to the notebook training in the 6 week and 10 day versions of the intervention to the computer activity group. The investigators will also collect data on the clinical efficacy of the notebook and computer training to investigate if these interventions can sustain/improve functional level. Long term goals for this project also include delaying relocation for persons with MCI who may progress to dementia, thus not only improving the lives of these individuals, but also reducing health care expenditures.

The investigators will recruit a total of 60 individuals with MCI and their 60 program partners across all three sites for this project. At least 16 of these pairs will be recruited at Emory University (maximum of 20 pairs/40 individuals anticipated). The investigators will randomly assign participants to the 6 week notebook or computer training or 10 day notebook or computer training. All participants will also receive patient education regarding MCI and cognitive health.

Subsequent compliance with the MSS will be examined at 3 months, 6 months, and then annually following the intervention. Outcome measures will provide a detailed, multi-modal assessment of participants' functional level, overall cognitive functioning, mood, and self-efficacy, as well as caregiver burden and mood.

Visão geral do estudo

Tipo de estudo

Intervencional

Inscrição (Real)

128

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Arizona
      • Scottsdale, Arizona, Estados Unidos, 85259
        • Mayo Clinic - Scottsdale
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30329
        • Emory University
    • Minnesota
      • Rochester, Minnesota, Estados Unidos, 55905
        • Mayo Clinic-Rochester

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Enrolled as a research participant in the Alzheimer's Disease Research Center with a consensus diagnosis of amnestic Mild Cognitive Impairment (MCI: single domain or multi-domain).
  • Has a program partner that has at least twice weekly contact with the participant
  • Dementia Rating Scale-2nd Edition (DRS-2) score of 115 or greater
  • Functional Ability Questionnaire (FAQ) score below 6.
  • Program Partner with Mini Mental State Exam (MMSE) of 24 or greater. (If a program partner has an MMSE less than 24, the site PI will recommend that the person seek further evaluation of cognition through their primary care physician. The person with MCI will be encouraged to find an alternate program partner.)
  • Either not taking or stable on nootropic(s) for at least 3 months
  • Has English as primary language

Exclusion Criteria:

  • Diagnosis other than amnestic MCI (single domain or multi-domain)
  • Visual/hearing impairment or history of reading/writing disability sufficient to interfere with training
  • Inclusion in another clinical trial that would exclude participation. Subject will be considered for participation at the end of such a trial or as appropriate.
  • Baseline score on the self-report depression measure suggesting severe depression for either the participant or the program partner (>21 on the Centers for Epidemiological Studies - Depression Scale (CES-D) and need for psychiatric treatment. (If a patient or program partner has a CES-D greater than 21, the site Principal Investigator will rule out suicidal ideation and then recommend that the person seek further evaluation of mood from their primary care physician, psychiatrist, or other mental health practitioner. If they seek treatment and have been stable on that treatment for 3 months, they would then be allowed to be reconsidered for the study.)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Memory Support System or Computer
Training in use of a memory notebook system
Outros nomes:
  • MSS
Computer brain fitness training
Outros nomes:
  • POSIT

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
To assess participant adherence to Memory Support System (MSS) use at different levels (6 week, 10 day, or computer activity) of the training intervention. This will be measured by an overall adherence score (Adherence Assessment).
Prazo: Baseline
Baseline
To assess participant adherence to (Memory Support System) MSS use at different levels (6 week, 10 day, or computer activity) of the training intervention. This will be measured by an overall adherence score (Adherence Assessment).
Prazo: Intervention End
Intervention End
To assess participant adherence to (Memory Support System)MSS use at different levels (6 week, 10 day, or computer activity) of the training intervention. This will be measured by an overall adherence score (Adherence Assessment).
Prazo: 3 Month post intervention
3 Month post intervention
To assess participant adherence to (Memory Support System) MSS use at different levels (6 week, 10 day, or computer activity) of the training intervention. This will be measured by an overall adherence score (Adherence Assessment).
Prazo: 6 Months post intervention
6 Months post intervention
To assess participant adherence to (Memory Support System) MSS use at different levels (6 week, 10 day, or computer activity) of the training intervention. This will be measured by an overall adherence score (Adherence Assessment).
Prazo: 1 Year post intervention
1 Year post intervention

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Melanie Greenaway, PhD, Emory University
  • Investigador principal: Dona EC Locke, PhD, Mayo Clinic

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de outubro de 2010

Conclusão Primária (Real)

1 de agosto de 2013

Conclusão do estudo (Real)

1 de julho de 2014

Datas de inscrição no estudo

Enviado pela primeira vez

11 de janeiro de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

24 de janeiro de 2011

Primeira postagem (Estimativa)

25 de janeiro de 2011

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

4 de dezembro de 2014

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de dezembro de 2014

Última verificação

1 de dezembro de 2014

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • IRB00034934
  • R01NR012419 (Concessão/Contrato do NIH dos EUA)

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 .

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