- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Sivas, Turquía (Türkiye), 58000
- Sivas Numune Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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.
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The home care guide developed for activities of daily living was provided to the intervention group, and training related to it was delivered.
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Sin intervención: Control Group
In the control group, pre-test and post-test were administered without any intervention.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Personal Information Form for Caregivers
Periodo de tiempo: This intervention was applied to both the intervention and control groups during pre-testing conducted in weeks 0-4 of the study.
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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.
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This intervention was applied to both the intervention and control groups during pre-testing conducted in weeks 0-4 of the study.
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Caregiver Burden Scale
Periodo de tiempo: 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).
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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.
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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).
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Bakas Caregiving Outcomes Scale
Periodo de tiempo: 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).
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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.
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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).
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: MUKADDER MOLLAOĞLU, Prof.Dr., Cumhuriyet University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2024-12/43
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .