Vet-Harts Pilot Intervention for Veterans With Coronary Heart Disease (VHPI)
12 de junho de 2018 atualizado por: VA Office of Research and Development
Representational Telehealth Nursing Intervention for Veterans With CHD
The purpose of this research study is to survey patients to learn about their beliefs and behaviors related to the management of heart disease and to discuss options for making healthy lifestyle changes.
From the information the investigators get from patients, the investigators hope to develop better methods for taking care of patients who have heart disease.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Coronary heart disease (CHD) is a significant health threat among veterans.
Compared to their civilian counterparts, veterans experience greater disability, reinfarction, and mortality following myocardial infarction (MI) and other acute coronary syndromes (ACS).
High rates of hypertension, diabetes, and cardiac risk behaviors (e.g., smoking) and low socioeconomic status (SES) further increase veterans' CHD-related morbidity and mortality.
The proposed pilot project will establish the feasibility of a telehealth nursing intervention for veterans with CHD who are recovering from MI/ACS.
The Veterans Heart Attack Representations Telehealth (Vet-HART) intervention is designed to promote adaptive conceptual change in veterans' beliefs (common sense models or representations) about CHD etiology and self-management and facilitate health behavior changes (e.g., smoking cessation, medication adherence, diet management, and increased physical activity).
The long-term goal of this research program is to improve veterans' quality of life (QoL) and reduce their CHD-related morbidity/mortality.
The proposed project is the requisite next step in attaining that goal.
Tipo de estudo
Intervencional
Inscrição (Real)
12
Estágio
- Fase 2
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
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Iowa
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Iowa City, Iowa, Estados Unidos, 52246-2208
- Iowa City VA Health Care System, Iowa City, IA
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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:
- Admission to an inpatient medicine unit for MI, ACS, and coronary angiography
- Age
Exclusion Criteria:
- Altered mental status
- Language barriers
- Dementia or Cognitive Impairment
- Diagnostic Study
- Resident in long-term care facility prior to the present admission
- Planned discharge to a skilled or intermediate care facility or hospice
- Lack of access to a functioning phone
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: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Motivational Interview
For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention.
The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.
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For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention.
The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.
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Sem intervenção: Usual Care
For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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SF-36v Physical Function Scale
Prazo: Change from baseline to 3-months post hospital discharge
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Physical Functioning Subscale from the SF-36v.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
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Change from baseline to 3-months post hospital discharge
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SF-36v Role Limitations Due to Physical Health Scale
Prazo: Change from baseline to 3-months post hospital discharge
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Role Limitations Due to Physical Health Subscale from the SF-36v.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
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Change from baseline to 3-months post hospital discharge
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SF-36v Role Limitations Due to Emotional Problems Scale
Prazo: Change from baseline to 3-months post hospital discharge
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Role Limitations Due to Emotional Problems Scale from the SF-36v.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
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Change from baseline to 3-months post hospital discharge
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SF-36v Energy-Fatigue Scale
Prazo: Change from baseline to 3-months post hospital discharge
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Energy-Fatigue Subscale from the SF-36v.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
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Change from baseline to 3-months post hospital discharge
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SF-36v Emotional Well-Being Scale
Prazo: Change from baseline to 3-months post hospital discharge
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Emotional Well-Being Subscale from the SF-36v.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
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Change from baseline to 3-months post hospital discharge
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SF-36v Social Functioning Scale
Prazo: Change from baseline to 3-months post hospital discharge
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Social Functioning Subscale from the SF-36v.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
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Change from baseline to 3-months post hospital discharge
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SF-36v Pain Scale
Prazo: Change from baseline to 3-months post hospital discharge
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Pain Subscale from the SF-36v.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
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Change from baseline to 3-months post hospital discharge
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SF-36v General Health Scale
Prazo: Change from baseline to 3-months post hospital discharge
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General Health Subscale from the SF-36v.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
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Change from baseline to 3-months post hospital discharge
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Seattle Angina Questionnaire Physical Limitations Scale
Prazo: Change from baseline to 3-months post hospital discharge
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Physical Limitations Subscale from the Seattle Angina Questionnaire.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
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Change from baseline to 3-months post hospital discharge
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Seattle Angina Questionnaire Angina Stability Scale
Prazo: Change from baseline to 3-months post hospital discharge
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Angina Stability Subscale from the Seattle Angina Questionnaire.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
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Change from baseline to 3-months post hospital discharge
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Seattle Angina Questionnaire Angina Frequency Scale
Prazo: Change from baseline to 3-months post hospital discharge
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Angina Frequency Subscale from the Seattle Angina Questionnaire.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
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Change from baseline to 3-months post hospital discharge
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Seattle Angina Questionnaire Treatment Satisfaction Scale
Prazo: Change from baseline to 3-months post hospital discharge
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Treatment Satisfaction Subscale from the Seattle Angina Questionnaire.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
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Change from baseline to 3-months post hospital discharge
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Seattle Angina Questionnaire Disease Perception Scale
Prazo: Change from baseline to 3-months post hospital discharge
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Disease Perception Subscale from the Seattle Angina Questionnaire.
Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.
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Change from baseline to 3-months post hospital discharge
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mark W Vander Weg, PhD MS BA, Iowa City VA Health Care System, Iowa City, IA
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 (Real)
30 de abril de 2012
Conclusão Primária (Real)
30 de junho de 2012
Conclusão do estudo (Real)
31 de outubro de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
19 de março de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
26 de março de 2012
Primeira postagem (Estimativa)
29 de março de 2012
Atualizações de registro de estudo
Última Atualização Postada (Real)
24 de dezembro de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de junho de 2018
Última verificação
1 de junho de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PPO 09-283
- 200910778 (Outro identificador: University of Iowa)
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