- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07640412
MPACT OF A HOME CARE GUIDE FOR DAILY LIVING ACTIVITIES ON STROKE CAREGIVERS' BURDEN AND EXPERIENCE
THE EFFECT OF A HOME CARE GUIDE DEVELOPED FOR ACTIVITIES OF DAILY LIVING ON THE CAREGIVER BURDEN AND EXPERIENCES OF STROKE PATIENT CAREGIVERS
The study aims to develop a home care guide, led by nurses, for stroke patients to maintain their activities of daily living, based on evidence-based current literature and guidelines, and to test the effect of this guide on caregiver burden. The results expected from this study are anticipated to contribute to the continuity of care in stroke patients, enhance self-care abilities through participation in daily activities, ensure adherence to treatment and care, control symptoms, reduce repeated hospitalizations, and improve the quality of life of caregivers by alleviating their caregiver burden.
The study was conducted in the home environment with caregivers of stroke patients registered at the Home Health Services unit of Sivas Numune Hospital.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Sivas, Turquia (Türkiye), 58000
- Sivas Numune Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Individuals who have a patient diagnosed with stroke at least 6 months ago,
- Those who are in the position of providing continuous care,
- Those whose care recipients have a score below 60 on the Barthel Activities of Daily Living Index,
- Individuals who volunteer to participate in the study will be included in the study.
Exclusion Criteria:
- Individuals who have participated in a similar study in which training on home care for stroke patients was provided,
- Those who have physical, cognitive, or memory-related problems,
- Those whose care recipients have a score of 60 or above on the Barthel Activities of Daily Living Index,
- Individuals who do not agree to participate in the study will not be included in the study.
Plano de estudo
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 |
|---|---|
|
Comparador Ativo: HOME CARE GUIDE
The intervention group received training along with the developed home care guide, and pre-test, mid-test, and post-test were administered.
|
The home care guide developed for activities of daily living was provided to the intervention group, and training related to it was delivered.
|
|
Sem intervenção: Control Group
In the control group, pre-test and post-test were administered without any intervention.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Personal Information Form for Caregivers
Prazo: This intervention was applied to both the intervention and control groups during pre-testing conducted in weeks 0-4 of the study.
|
It includes items such as the caregiver's demographic data (age, gender, marital status, number of children, education level, occupation, degree of relationship to the patient, income status), patient care experience, the presence of chronic diseases accompanying the stroke diagnosis, and the duration of caregiving.
|
This intervention was applied to both the intervention and control groups during pre-testing conducted in weeks 0-4 of the study.
|
|
Caregiver Burden Scale
Prazo: The intervention group was administered a pre-test (weeks 0-4), an intermediate test (weeks 5-8), and a post-test (weeks 9-12), while the control group received a pre-test (weeks 0-4) and a post-test (weeks 9-12).
|
The scale consists of 22 items that determine the impact of caregiving on the lives of individuals who care for a person in need.
The scale is a Likert-type instrument ranging from 0 to 4, with the options 'never,' 'rarely,' 'sometimes,' 'quite frequently,' and 'almost always.'
The minimum score that can be obtained from the scale is 0 and the maximum score is 88.
The items in the scale generally focus on social and emotional aspects, and a higher total score indicates a higher level of distress experienced by the caregiver.
The scores are evaluated as follows: 0-20 indicates little or no burden, 21-40 indicates mild to moderate burden, 41-60 indicates moderate to severe burden, and 61-88 indicates severe burden.
The Cronbach's alpha reliability coefficient of the scale is 0.95.
|
The intervention group was administered a pre-test (weeks 0-4), an intermediate test (weeks 5-8), and a post-test (weeks 9-12), while the control group received a pre-test (weeks 0-4) and a post-test (weeks 9-12).
|
|
Bakas Caregiving Outcomes Scale
Prazo: The intervention group was administered a pre-test (weeks 0-4), an intermediate test (weeks 5-8), and a post-test (weeks 9-12), while the control group received a pre-test (weeks 0-4) and a post-test (weeks 9-12).
|
The scale consists of 16 items and evaluates the positive and negative life changes experienced as a result of caregiving, ranging from the best direction (+3) to the worst direction (-3) (min.
15, max.
105).
The scale has no subdimensions.
As the total score obtained from the scale increases, it indicates a 'positive change,' while a decrease in the score indicates a 'negative change.'
The Turkish validity and reliability study of the scale was conducted by Can and Cavlak in 2010.
In that study, the internal consistency coefficient of the scale was found to be 0.90, and the test-retest reliability was 0.961.
|
The intervention group was administered a pre-test (weeks 0-4), an intermediate test (weeks 5-8), and a post-test (weeks 9-12), while the control group received a pre-test (weeks 0-4) and a post-test (weeks 9-12).
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: MUKADDER MOLLAOĞLU, Prof.Dr., Cumhuriyet University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2024-12/43
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA 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 .