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- Ensaio Clínico NCT00113139
Investigational Study of Psychological Intervention in Recipients of Lung Transplant (INSPIRE) (INSPIRE)
An Investigation to Examine a Telephone Based Stress Management and Coping Skills Intervention for Patients Waiting for Lung Transplant
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
BACKGROUND:
Lung transplantation is a relatively new procedure developed to increase life expectancy in selected individuals with irreversible end-stage lung disease. In the brief period since its inception, it appears that lung transplantation has achieved its initial aim of extending life. Despite these successes, lung transplantation remains fraught with difficult challenges for the patient and the medical community. The pre-surgical waiting period is a particularly stressful time. The long, uncertain wait for an organ, the marked decline in functional capacity, the tremendous financial burden, and the prospect of a complicated medical regimen after surgery, combine to exert a profound strain on patients' coping capacities. Not surprisingly, the rate of clinically significant psychological distress during this period is quite high, with rates of clinical depression, panic, anxiety and adjustment disorders far exceeding those observed in the general population. Although it is well established that brief, focused cognitive-behavioral therapy (CBT) can significantly improve psychological function in medically ill persons, the wide geographic distribution of transplant patients, along with their marked debilitation makes face-to-face delivery of such therapy extremely difficult. Recent pilot data have demonstrated the feasibility and short-term efficacy of a telephone-based psychological intervention with patients awaiting transplant.
DESIGN NARRATIVE:
INSPIRE was a collaborative study between Duke University Medical Center and Washington University Medical School. Participants first completed a baseline evaluation, including an interview with a staff member, tests of memory and concentration, and a questionnaire packet. They were then randomly assigned (by chance) to one of 2 groups: Stress Management (by phone) or Usual Care. Stress management participants received a phone call from an INSPIRE interventionist every week for 12 weeks; the phone sessions focused on helping to reduce stress and learning new skills to better cope with lung disease and the upcoming transplant. The INSPIRE staff interventionists were all psychologists who had been trained to work with patients with lung disease. Usual care participants continued their routine and usual treatments and did not receive the 12 telephone training sessions. Participants completed follow-up evaluations three months after the initial (baseline) evaluation, after transplant surgery, and twelve months after the initial evaluation. The primary outcome measures were measures of health-related quality of life, general psychological well-being, and social support.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Potential lung-transplant candidates listed for lung transplantation at Duke University Medical Center or Washington University
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Telephone-based coping skills
Telephone-based coping skills intervention
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Telephone-based coping skills/stress management: 12 weekly sessions.
Outros nomes:
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Comparador Ativo: Cuidados usuais
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Usual care participants continued their routine and usual treatments and do not receive the 12 telephone training sessions.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Survival/all-cause mortality
Prazo: 6 months & 18 months post-transplant
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6 months & 18 months post-transplant
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Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Quality of live
Prazo: 6 months & 18 months post-transplant
|
6 months & 18 months post-transplant
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: James A Blumenthal, Ph.D, Duke University Medical Center, Dept of Psychiatry & Behavioral Sciences
Publicações e links úteis
Publicações Gerais
- Napolitano MA, Babyak MA, Palmer S, Tapson V, Davis RD, Blumenthal JA; Investigational Study of Psychological Intervention in Recipients of Lung Transplant (INSPIRE) Investigators. Effects of a telephone-based psychosocial intervention for patients awaiting lung transplantation. Chest. 2002 Oct;122(4):1176-84. doi: 10.1378/chest.122.4.1176.
- Parekh PI, Blumenthal JA, Babyak MA, LaCaille R, Rowe S, Dancel L, Carney RM, Davis RD, Palmer S; INSPIRE Investigators. Gas exchange and exercise capacity affect neurocognitive performance in patients with lung disease. Psychosom Med. 2005 May-Jun;67(3):425-32. doi: 10.1097/01.psy.0000160479.99765.18.
- Parekh PI, Blumenthal JA, Babyak MA, Merrill K, Carney RM, Davis RD, Palmer SM; INSPIRE Investigators. Psychiatric disorder and quality of life in patients awaiting lung transplantation. Chest. 2003 Nov;124(5):1682-8. doi: 10.1378/chest.124.5.1682.
- Smith PJ, Blumenthal JA, Carney RM, Freedland KE, O'Hayer CVF, Trulock EP, Martinu T, Schwartz TA, Hoffman BM, Koch GG, Davis RD, Palmer SM. Neurobehavioral functioning and survival following lung transplantation. Chest. 2014 Mar 1;145(3):604-611. doi: 10.1378/chest.12-2127.
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Pro00009150
- R01HL065503 (Concessão/Contrato do NIH dos EUA)
- 176
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