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- Ensaio Clínico NCT03741842
"COMBO-KEY" - A Home Visiting and Phone Coaching Programme to Promote Stroke Survivors' Recovery
25 de agosto de 2022 atualizado por: Suzanne HS Lo, Chinese University of Hong Kong
"COMBO-KEY" (Coaching Ongoing Momentum Building On stroKe rEcovery journeY) - A Home Visiting and Phone Coaching Programme to Promote Stroke Survivors' Recovery: A Territory-wide Project
Building confidence and capabilities to transfer rehabilitative knowledge and skills into lifestyle-workable strategies for changing health behaviours among stroke survivors are important to optimise health outcomes and reduce risks of recurrent stroke.
The aim of this project is to promote stroke survivors' health by building confidence and positive expectations of recovery outcomes, and enabling their engagement in stroke self-management behaviours.
Visão geral do estudo
Descrição detalhada
A randomised controlled trial will be conducted to determine the effectiveness of a programme "Coaching Ongoing Momentum Building On stroKe rEcovery journeY" ("COMBO-KEY"), a home visiting and phone coaching programme, on community-dwelling stroke survivors' self-efficacy, outcome expectation, and engagement in stroke self-management behaviours.
An estimated sample of 134 stroke survivors will be recruited.
COMBO-KEY will be underpinned by Bandura's constructs of self-efficacy and outcome expectation.
It will be delivered by trained coaches.
Outcomes will be measured at baseline and immediately after completion of the programme.
Generalised estimating equations model will be used to assess the differential changes in outcome variables from pre-test to post-test between the intervention and control groups with adjustment for their baseline levels.
Tipo de estudo
Intervencional
Inscrição (Real)
134
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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Hong Kong, Hong Kong
- Community settings
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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
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Clinically diagnosed with stroke
- 18 years old or above
- Community dwelling
- Have a modified Rankin Scale score equal to or greater than 3 (moderate to severe disability)
- Have a Montreal Cognitive Assessment score >20
Exclusion Criteria:
- Have severe dysphasia
- Are diagnosed with a mental illness
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 |
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Experimental: COMBO-KEY group
The participants in the intervention group will receive a home visiting and phone coaching self-management programme (Coaching Ongoing Momentum Building On stroKe rEcovery journeY "COMBO-KEY") which is underpinned by Bandura's constructs of self-efficacy and outcome expectation.
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The intervention will last for eight weeks with four home visits and five phone coaching sessions.
It will also consist of a 4-item resource package for stroke survivors (including a stroke self-management and self-discovery workbook, a health and life planning toolkit, and videos on sharing of experience by survivors who managed their post-stroke challenges successfully, and a stroke self-management quick reference guide).
A telephone hotline for survivors and caregivers to seek information and support related to stroke self-management will also be established.
A programme protocol will be developed to ensure the consistent delivery of the programme.
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Sem intervenção: Usual care group
The participants in the usual care group will receive usual rehabilitation services offered, including services by a community rehabilitation network such as exercise training, physical rehabilitation, or activities organised by stroke support groups.
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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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Change in the level of self-efficacy in performing daily functional activities and self management
Prazo: Change from baseline level to immediately after completion of the intervention
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The 13-item Chinese version of the Stroke Self-Efficacy Questionnaire will be used.
The items assess the stroke survivors' confidence in performing self-management behaviours over a 0-no confidence to 10-very confident points scale.
All item scores are summed (total 0-130).
Higher scores indicate higher self-efficacy.
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Change from baseline level to immediately after completion of the intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Change in the level of outcome expectation of stroke self-management behaviours
Prazo: Change from baseline level to immediately after completion of the intervention
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The 11-item Chinese version of the Stroke Self-management Outcome Expectation Scale will be used.
The items assess the stroke survivors' confidence in the occurrence of outcomes after performing the self-management behaviours.
All item scores are summed (total 0-110; each item is rated over 0-Strongly disagree to 10-Strongly agree).
Higher scores represent higher confidence towards positive outcome.
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Change from baseline level to immediately after completion of the intervention
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Change in the level of satisfaction with performance of stroke self-management behaviours
Prazo: Change from baseline level to immediately after completion of the intervention
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The 11-item Chinese version of the Stroke Self-management Behaviours Performance Scale will be used.
The items ask the stroke survivors' satisfaction with their performance of self-management behaviours.
All item scores are summed (total 0-110; each item is rated over 0-Strongly disagree to 10-Strongly agree).
Higher scores represent higher satisfaction.
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Change from baseline level to immediately after completion of the intervention
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Change in the level of health-related quality of life
Prazo: Change from baseline level to immediately after completion of the intervention
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The 49-item Chinese version of the Stroke Specific Quality of Life Scale will be used.
The items ask the stroke survivors' agreement to the health conditions and difficulties in performing the tasks described.
All item scores are summed (total 49-245; 1-Strongly disagree/couldn't do it to 5-Strongly agree/no trouble).
Higher scores represent higher health-related quality of life.
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Change from baseline level to immediately after completion of the intervention
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Change in the level of depressive symptoms
Prazo: Change from baseline level to immediately after completion of the intervention
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The 15-item Chinese version of the Geriatric Depression Scale will be used.
The stroke survivors will be asked for agreement to the items based on their condition (total 0-15; Yes-1 score or No-0 score).
A score of 5-8 indicates mild depression; 9-11 moderate depression; and 12-15 severe depression.
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Change from baseline level to immediately after completion of the intervention
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Change in the level of community reintegration
Prazo: Change from baseline level to immediately after completion of the intervention
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The 11-item Chinese version of the Reintegration to Normal Living Index will be used.
The stroke survivors will be asked the extent to which the items described their situation (total 11-55; 1-A small extent to 5-A great extent).
Higher scores represent better community reintegration.
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Change from baseline level to immediately after completion of the intervention
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Satisfaction with the programme (Participants in the intervention group)
Prazo: Immediately after completion of the intervention
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Rate the ease of use and relevance of contents and resources, arrangement, and coaches' performance on a 5-Likert point (1-Very dissatisfied to 5-Very satisfied)
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Immediately after completion of the intervention
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Usage of the resource package (Participants in the intervention group)
Prazo: Immediately after completion of the intervention
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Frequency (minutes) of using the resource package per week
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Immediately after completion of the intervention
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Level of goal attainment (Participants in the intervention group)
Prazo: Immediately after completion of the intervention
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Rate the level of goal attainment on a scale from 0-Not attained, 1-Partially attained, to 2-Completely attained
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Immediately after completion of the intervention
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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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)
1 de março de 2019
Conclusão Primária (Real)
30 de junho de 2022
Conclusão do estudo (Real)
30 de junho de 2022
Datas de inscrição no estudo
Enviado pela primeira vez
12 de novembro de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
13 de novembro de 2018
Primeira postagem (Real)
15 de novembro de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
29 de agosto de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de agosto de 2022
Última verificação
1 de agosto de 2022
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 01170718
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .
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