Hospice Problem Solving Intervention
17 de novembro de 2017 atualizado por: George Demiris, University of Washington
A Problem Solving Intervention for Hospice Caregivers
In recent years, the demand for home hospice care has grown rapidly.
Family members and friends who act as informal caregivers are essential to the provision of palliative care services; however, this role is not without adverse effects on the caregivers themselves.
It is well documented that emotional needs of individuals caring for dying persons in their home are not well attended, and interventions aiming to provide support to informal hospice caregivers are notably lacking.
In this context, problem solving therapy (PST) provides an overall coping process that fosters adaptive situational coping and behavioral competence.
The investigators are conducting a randomized controlled trial to fully evaluate the PST intervention for informal hospice caregivers.
Additionally, the investigators aim to evaluate how the modality of the intervention (face to face vs video) impacts its effectiveness.
This investigator team is conducting a 4-year randomized trial study in which hospice caregivers will be randomly assigned to a group receiving standard hospice care with the addition of social support interactions (attention control group) or a group receiving standard hospice care with the addition of the problem solving intervention delivered face to face (intervention group 1) or a group receiving standard hospice care with the addition of the problem solving intervention delivered via video (intervention group 2).
The specific aims include an assessment of the impact of PST on caregiver quality of life, problem solving ability, and caregiver anxiety.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
514
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
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Washington
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Seattle, Washington, Estados Unidos, 98195
- University of Washington
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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:
- enrolled as a family/informal caregiver of a hospice patient
- 18 years or older
- with access to a standard phone line or Internet and computer access at home
- without functional hearing loss or with a hearing aid that allows the participant to conduct telephone conversations as assessed by the research staff (by questioning and observing the caregiver)
- no or only mild cognitive impairment
- speak and read English, with at least a 6th-grade education
Exclusion Criteria:
- lack of phone or Internet access
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: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Sem intervenção: Attention Control
This group receives standard care with the attention of social support/ "friendly interactions" and serves as an attention control group.
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Experimental: Intervention Group 1 (Face to Face)
This group receives Problem Solving Therapy in face to face visits.
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Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework.
PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation.
The intervention is delivered in a series of interactions with the interventionist.
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Experimental: Intervention Group 2 (Video)
This group receives Problem Solving Therapy via video.
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Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework.
PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation.
The intervention is delivered in a series of interactions with the interventionist.
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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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Caregiver Anxiety: Change From Baseline to Post-Intervention Exit
Prazo: At Baseline and Exit (approximately 4 weeks after recruitment)
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Caregiver anxiety was measured with the 7-item Generalized Anxiety Disorder (GAD-7) Scale (Spitzer et al., 2006), which measures the frequency with which respondents experience symptoms of anxiety such as restlessness, difficulty relaxing, and uncontrollable worrying.
The GAD-7 total scores range from 0 to 21, with higher scores indicating more anxiety.
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At Baseline and Exit (approximately 4 weeks after recruitment)
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Caregiver Quality of Life - Physical: Change From Baseline to Post-Intervention Exit
Prazo: At Baseline and Exit (approximately 4 weeks after recruitment)
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An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale.
Higher scores indicate better physical quality of life.
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At Baseline and Exit (approximately 4 weeks after recruitment)
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Caregiver Quality of Life - Social: Change From Baseline to Post-Intervention Exit
Prazo: At Baseline and Exit (approximately 4 weeks after recruitment)
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An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale.
Higher scores indicate better social quality of life.
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At Baseline and Exit (approximately 4 weeks after recruitment)
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Caregiver Quality of Life - Emotional: Change From Baseline to Post-Intervention Exit
Prazo: At Baseline and Exit (approximately 4 weeks after recruitment)
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An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale.
Higher scores indicate better emotional quality of life.
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At Baseline and Exit (approximately 4 weeks after recruitment)
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Caregiver Quality of Life - Financial: Change From Baseline to Post-Intervention Exit
Prazo: At Baseline and Exit (approximately 4 weeks after recruitment)
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An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale.
Higher scores indicate better financial quality of life.
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At Baseline and Exit (approximately 4 weeks after recruitment)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: George Demiris, PhD, University of Washington
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.
Publicações Gerais
- Starr LT, Bullock K, Washington K, Aryal S, Parker Oliver D, Demiris G. Anxiety, Depression, Quality of Life, Caregiver Burden, and Perceptions of Caregiver-Centered Communication among Black and White Hospice Family Caregivers. J Palliat Med. 2022 Apr;25(4):596-605. doi: 10.1089/jpm.2021.0302. Epub 2021 Nov 18.
- Demiris G, Oliver DP, Washington K, Pike K. A Problem-Solving Intervention for Hospice Family Caregivers: A Randomized Clinical Trial. J Am Geriatr Soc. 2019 Jul;67(7):1345-1352. doi: 10.1111/jgs.15894. Epub 2019 Apr 4.
- Benson JJ, Parker Oliver D, Demiris G, Washington K. Accounts of Family Conflict in Home Hospice Care: The Central Role of Autonomy for Informal Caregiver Resilience. J Fam Nurs. 2019 May;25(2):190-218. doi: 10.1177/1074840719828091. Epub 2019 Feb 17.
- Tarter R, Demiris G, Pike K, Washington K, Parker Oliver D. Pain in Hospice Patients With Dementia: The Informal Caregiver Experience. Am J Alzheimers Dis Other Demen. 2016 Sep;31(6):524-9. doi: 10.1177/1533317516653825. Epub 2016 Jun 14.
- Oliver DP, Demiris G, Washington KT, Clark C, Thomas-Jones D. Challenges and Strategies for Hospice Caregivers: A Qualitative Analysis. Gerontologist. 2017 Aug 1;57(4):648-656. doi: 10.1093/geront/gnw054.
- Washington KT, Pike KC, Demiris G, Parker Oliver D, Albright DL, Lewis AM. Gender Differences in Caregiving at End of Life: Implications for Hospice Teams. J Palliat Med. 2015 Dec;18(12):1048-53. doi: 10.1089/jpm.2015.0214. Epub 2015 Oct 20.
- Washington KT, Pike KC, Demiris G, Oliver DP. Unique characteristics of informal hospice cancer caregiving. Support Care Cancer. 2015 Jul;23(7):2121-8. doi: 10.1007/s00520-014-2570-z. Epub 2014 Dec 30.
- Washington KT, Wittenberg-Lyles E, Oliver DP, Baldwin PK, Tappana J, Wright JH, Demiris G. Rethinking family caregiving: tailoring cognitive-behavioral therapies to the hospice experience. Health Soc Work. 2014 Nov;39(4):244-50. doi: 10.1093/hsw/hlu031.
- Washington KT, Demiris G, Pike KC, Kruse RL, Oliver DP. Anxiety among informal hospice caregivers: an exploratory study. Palliat Support Care. 2015 Jun;13(3):567-73. doi: 10.1017/S1478951513001193. Epub 2014 Feb 13.
- Demiris G, Parker Oliver D, Capurro D, Wittenberg-Lyles E. Implementation science: implications for intervention research in hospice and palliative care. Gerontologist. 2014 Apr;54(2):163-71. doi: 10.1093/geront/gnt022. Epub 2013 Apr 4.
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 2011
Conclusão Primária (Real)
1 de março de 2016
Conclusão do estudo (Real)
1 de março de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
28 de setembro de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de setembro de 2011
Primeira postagem (Estimativa)
30 de setembro de 2011
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de dezembro de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de novembro de 2017
Última verificação
1 de novembro de 2017
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 36909
- 1R01NR012213-01A1 (Concessão/Contrato do NIH dos EUA)
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