Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Preventing Aggression in Veterans With Dementia (PAVeD)

19 de maio de 2016 atualizado por: VA Office of Research and Development
This study tests whether education about memory and pain might help to prevent aggression in persons with dementia who have pain. The overall goal of this intervention is to reduce the risk of aggressive behavior by improving several areas of patient life that are known causes of aggression: pain, depression, lack of pleasurable activities, caregiver stress and difficulty in caregiver-patient communication.

Visão geral do estudo

Descrição detalhada

Dementia is known primarily for its effects on memory, however, eighty percent of persons with dementia also have behavioral disturbances. This is often not addressed, leading to increased use of nursing homes, higher incidence of injury (both patient and caregiver) and the use of tranquilizing medications. Pain is one of the strongest predictors of aggression. The prevalence of pain in persons with dementia is known to be about 50%. Untreated pain is associated with significant negative outcomes, including increased health care use, inactivity and isolation. The investigators aim to determine whether outcome differences exist between active intervention and control conditions in relation to the occurrence of aggressive behavior, pain and depression, and its impact on pleasant activities, caregiver burden, quality of caregiver-patient relationship, antipsychotic use, health-service use, injuries to patient and caregiver, and nursing home placement. The active intervention, Preventing Aggression in Veterans with Dementia (PAVeD), is a family caregiver-focused, home-based intervention that uses psychoeducational and behavioral approaches to help reduce the risk of aggressive behavior in persons with dementia. The objective of PAVeD is to improve several areas of patient life that are known causes of aggression: pain and distress (including mood problems), lack of pleasurable activities, and difficulty in patient-caregiver communication that may negatively affect relationship quality and caregivers' recognition of pain.

Tipo de estudo

Intervencional

Inscrição (Real)

203

Estágio

  • Fase 3

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

    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • Michael E. DeBakey VA Medical Center, Houston, TX

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

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

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

Patients will be eligible to participate in the study if they meet the following criteria:

  • have a documented diagnosis of dementia
  • receive primary care from the VA
  • reside outside a long-term care facility
  • live within 45 minutes of the MEDVAMC
  • have mild-to-moderate dementia
  • have no history of aggression in the past year
  • have no evidence of aggression on the CMAI at baseline (i.e., do not score 2 or higher on both frequency and disruptiveness for any of 13 behaviors listed).
  • have a caregiver who is directly involved with the patient:

    • at least 8 hours per week
    • sees the patient at least twice a week
    • and speaks English
  • report clinically significant pain (either directly or through the caregiver as a proxy)

Exclusion Criteria:

Patients will be excluded if they have had history of aggression in the past year

  • The investigators will administer the aggression subscale of the Cohen-Mansfield Agitation Inventory (CMAI)
  • Aggression will be considered present if any of the following items are endorsed as having occurred over the prior year:

    • spitting
    • cursing/verbal aggression
    • hitting
    • kicking
    • grabbing
    • pushing
    • throwing
    • biting
    • scratching
    • hurting self/others
    • tearing things/destroying property
    • making inappropriate verbal sexual advances
    • or making inappropriate physical sexual advances

Participants that scored 2 or higher for both frequency and disruptiveness on any of the 13 behaviors listed on the CMAI at baseline were considered aggressive and were excluded from 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: Pesquisa de serviços de saúde
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Arm 1: PAVeD Intervention
In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.
In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.
Comparador Ativo: Arm 2: Enhanced Usual Care
In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.

In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.

Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale)
Prazo: Three Months, Six Months, Twelve Months Post Intervention

The CMAI lists 13 behaviors (2 verbal and 11 nonverbal) and for each behavior the participant indicates how frequently the behavior occurs (1-5, higher values = greater frequency) and how disruptive the behavior is (1-5, higher values = greater disruptiveness). For any given behavior, if a participant scored a 2 or higher on BOTH frequency (i.e., it occurred "less than once a week" or more often) and disruptiveness (i.e., it was "a little" disruptive or more), he/she was considered aggressive.

Overall aggression takes into account all 13 behaviors, whereas verbal aggression only pertains to two behaviors and non-verbal aggression pertains to 11 behaviors.

One is considered verbally aggressive if he/she responds with a 2 or higher on both frequency and disruptiveness for either of the two verbal behaviors.

One is considered non-verbally aggressive if he/she responds with a 2 or higher on both frequency and disruptiveness for any of the 11 non-verbal behaviors.

Three Months, Six Months, Twelve Months Post Intervention

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Caregiver-Reported Worst Pain
Prazo: Baseline, 3 months, 6 months, and 12 months

This is one item on the Philadelphia Pain Intensity Scale. One item with scores from 0 to 5, where 0 = no pain, 1 = little pain, 2 = moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable.

Higher scores = greater pain severity

Baseline, 3 months, 6 months, and 12 months
Patient-reported Worst Pain.
Prazo: Baseline, 3, 6, and 12 months

This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable.

Higher scores = greater pain severity.

Baseline, 3, 6, and 12 months
Caregiver Reported Overall Pain Over the Last Several Weeks
Prazo: Baseline, 3, 6, and 12 months.

This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable.

Higher scores = greater pain severity.

Baseline, 3, 6, and 12 months.
Patient-reported Overall Pain Over the Last Several Weeks
Prazo: Baseline, 3, 6, and 12 months

This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable.

Higher scores = greater pain severity.

Baseline, 3, 6, and 12 months
Depression
Prazo: Baseline, 3, 6, and 12 months

Geriatric Depression Scale. 30 item scale with response options of yes = 1 and no = 0 to each item.

Total GDS scores range from 0 to 30, with greater scores indicating greater depression.

Baseline, 3, 6, and 12 months
Pleasant Events - Short Form - Alzheimer's Disease
Prazo: Baseline, 0, 3, 6, 12 months

The frequency of engagement in pleasant events, according to the Pleasant Events Schedule - Alzheimer's Disease.

For each of 20 events, participants answered the frequency (0 = not at all, 1 = 1-6 times, 2 = 7+ times) they engaged in the event and whether they enjoyed the event (1 = yes, 0 = no).

For each item, frequency x enjoyment were multiplied. Then scores for each of the 20 items were added together.

The possible range of scores on the PES frequency of engagement in pleasant events is from 0 - 40, with higher scores indicating more frequent engagement in pleasant events.

Baseline, 0, 3, 6, 12 months
Caregiver Burden
Prazo: Baseline, 3, 6, 12 months

Caregiver-reported burden, according to the Burden Inventory. 22 items are responded to on a 0-4 scale where 0 = never, 1 = rarely, 2 = sometimes, 3 = quite frequently, and 4 = nearly always.

Scores are then summed so that the total range is from 0 to 88. Higher scores indicate greater caregiver burden.

Baseline, 3, 6, 12 months
Caregiver-perceived Mutuality
Prazo: Baseline, 3, 6, 12 months

Caregiver-Perceived Total Mutuality (with patient), based on the Mutuality Scale.

Fifteen items about the caregivers' relationship with the patient with dementia were responded to on a 0-4 scale, where 0 = not at all, 1 = a little, 2 = some, 3 = quite a bit, and 4 = a great deal.

responses to all 15 items were averaged, so total scores range from 0-4, with higher values indicating greater mutuality.

Baseline, 3, 6, 12 months

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Mark E. Kunik, MD MPH, Michael E. DeBakey VA Medical Center, Houston, TX

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

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 maio de 2011

Conclusão Primária (Real)

1 de fevereiro de 2015

Conclusão do estudo (Real)

1 de setembro de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

28 de março de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de março de 2011

Primeira postagem (Estimativa)

30 de março de 2011

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

24 de junho de 2016

Última atualização enviada que atendeu aos critérios de controle de qualidade

19 de maio de 2016

Última verificação

1 de maio de 2016

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

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 .

Se inscrever