- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00264745
Telephone Assessment and Skill-Building Kit (TASK): A New Program for Family Caregivers of Stroke Survivors
Caregiver Telephone Assessment and Skill-Building Kit
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Stroke is the number one cause of long-term disability in the United States. Many people who have had a stroke need help from family members after they go home. Taking care of a stroke patient can be hard since they can be unable to walk, talk, see, or think clearly. Behavior problems, changes in personality, and depression are also common. Providing care for a family member with stroke can often lead to caregiver depression, social isolation, and health problems. Not having caregiving skills may be one reason for these problems. Programs are needed to help caregivers learn caregiving skills. Such skills include finding information about stroke, dealing with the stroke patient's emotions and behaviors, providing personal and other types of care, and taking care of oneself as a caregiver.
The National Institute of Nursing Research said that learning how to help families cope with a relatives' chronic illness is a very important area for research. The TASK program is an attempt to meet this need. If the TASK program appears to be helpful and usable in this small beginning study, we will then try to test the program more completely in a much larger research study.
The informed consent explains the purpose and procedures for the study. The purpose is to test the TASK program in a small group of family caregivers of persons who have had a stroke. Caregivers are assigned to either the TASK group or a second group. The TASK group will get the TASK notebook, and the second group will get a brochure from the American Stroke Association. Both groups will get a telephone call every week for 8 weeks from a nurse, each lasting about 30 minutes. At the beginning and at 4, 8, and 12 weeks there will be a longer interview lasting about an hour. Caregivers get a $20 Wal-Mart gift card for each of the 4 interview calls. Calls are made at times that are convenient for the caregiver. All calls are tape-recorded. No names are used on the tape recordings or on any of the interview questionnaires. There is a very small risk that some parts of the study may remind some caregivers of their own situations and may be stressful or upsetting. Caregivers may choose not to answer questions or may leave the study at any time. Taking part in the study is up to them. Benefits include getting a $20 Wal-Mart gift card after each long interview (up to $80 in Wal-Mart gift cards for all 4 interviews). Caregivers also get free written information about stroke and caregiving, and free calls from a nurse. Telephone numbers are provided for questions about the study, rights as a research participant, and who to contact for emotional distress.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University School of Nursing
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- A family caregiver must (1) be an unpaid family member or friend of a stroke patient who has not been home from the hospital or nursing home more than 2 months, (2) be the main person who takes care of the stroke patient at home, (3) be able to read and speak English, (4) be able to talk and hear using the telephone, and (5) be willing to have 8 weekly calls from a nurse and 4 calls from a research assistant.
Exclusion Criteria:
- We are unable to enroll caregivers or stroke survivors who (1) have a very serious illness and are expected to live no more than 6 months, (2) have severe mental illness, (3) have a history of alcohol or drug abuse, (4) are pregnant, (5) are prisoners or on house arrest, or (6) are living in a nursing home.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 1
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The Telephone Assessment and Skill-building Kit (TASK) is an individualized 8-week intervention program geared toward reducing depression and improving general health in stroke caregivers.
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Comparador Ativo: 2
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Minimal intervention beyond initial hospital visit.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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To determine how useful the TASK program is for family caregivers; and to compare how difficult the caregiving tasks are for the caregivers, whether they feel depressed, and how they see their own health.
Prazo: baseline (within 2 months after the survivors discharge home), 4 weeks (half way through intervention), 8 weeks (end of intervention), 12 weeks.
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baseline (within 2 months after the survivors discharge home), 4 weeks (half way through intervention), 8 weeks (end of intervention), 12 weeks.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Tamilyn Bakas, RN, DNS, Indiana University School of Medicine
Publicações e links úteis
Publicações Gerais
- Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
- Bakas T, Li Y, Habermann B, McLennon SM, Weaver MT. Developing a cost template for a nurse-led stroke caregiver intervention program. Clin Nurse Spec. 2011 Jan-Feb;25(1):41-6. doi: 10.1097/NUR.0b013e318203cb92.
- Bakas T, Farran CJ, Austin JK, Given BA, Johnson EA, Williams LS. Content validity and satisfaction with a stroke caregiver intervention program. J Nurs Scholarsh. 2009;41(4):368-75. doi: 10.1111/j.1547-5069.2009.01282.x.
- Bakas T, Farran CJ, Austin JK, Given BA, Johnson EA, Williams LS. Stroke caregiver outcomes from the Telephone Assessment and Skill-Building Kit (TASK). Top Stroke Rehabil. 2009 Mar-Apr;16(2):105-21. doi: 10.1310/tsr1602-105.
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
- 1-35-6001673-A1
- K01NR008712 (Concessão/Contrato do NIH dos EUA)
- 1K01NR008712-01 (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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University of TurkuDesconhecidoSaudável | Comportamento de saúdeFinlândia
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Henry Ford Health SystemBlue Cross Blue Shield of Michigan FoundationConcluído
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Munich Municipal HospitalTechnical University of Munich; University of RegensburgDesconhecidoInfarto CerebralAlemanha
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Northwestern UniversityEmory UniversityConcluídoAfasia Progressiva Primária | Esgotamento do cuidadorEstados Unidos
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Rennes University HospitalUniversité de Rennes, Laboratoire du Traitement du Signal et de l'Image (LTSI) e outros colaboradoresConcluído
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Rhode Island HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development...ConcluídoCyberbullyingEstados Unidos
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University of VirginiaConcluídoLesão da medula espinal | Úlceras de pressãoEstados Unidos
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University of OklahomaVA Office of Research and Development; Alzheimer's Association; Oklahoma Shared... e outros colaboradoresConcluídoDemência | Doença de Alzheimer
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University Hospital, BordeauxConcluído