Non-pharmacological Interventions for People With Mild Cognitive Impairment in the Community (CNPI-MCI)
11 de julio de 2026 actualizado por: Yiran Yue, Anhui Medical University
Development of a 'Community-Family Mutual Support' Intervention Model for Patients With Mild Cognitive Impairment Based on Social Support Theory
Mild cognitive impairment (MCI) may increase the risk of dementia.
This study will evaluate an 8-week community-family mutual support intervention for adults aged 60 years or older with MCI.
Participants will be randomly assigned to an intervention group or a control group.
The control group will receive routine community care, while the intervention group will additionally receive cognitive training, health education, family support, mutual support activities, and individualized feedback.
Cognitive function, daily functioning, emotional status, and social support will be assessed before and after the intervention.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
70
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Yiran Yue
- Número de teléfono: 8617333266696
- Correo electrónico: yueyiran1@163.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Aged 60 years or older.
- Meets the diagnostic criteria for mild cognitive impairment, including subjective cognitive decline, objective impairment in at least one cognitive domain, relatively preserved activities of daily living, and no diagnosis of dementia.
- Has lived in the study community for at least 6 months.
- Has completed primary school or above and is able to read and write.
- Is able to communicate and complete the study assessments and intervention activities.
- Voluntarily participates and provides written informed consent.
Exclusion Criteria:
- Unable to communicate effectively.
- Has severe visual or hearing impairment that prevents participation.
- Has dementia, schizophrenia, or another severe psychiatric disorder.
- Has a serious or unstable physical illness that prevents participation in the intervention.
- Is currently participating in another cognitive training or similar intervention study.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Community-Family Mutual Support Intervention
Participants will receive routine community care plus an 8-week community-family mutual support intervention based on social support theory.
The intervention includes health education, cognitive training, emotional self-monitoring, family involvement, mutual support between participating families, group activities, and individualized feedback.
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Participants will receive an 8-week community-family mutual support intervention in addition to routine community care.
Guided by social support theory, the program integrates informational, emotional, instrumental, and appraisal support.
It includes MCI-related health education, cognitive training, physical activity guidance, emotional self-monitoring, home-based practice with family assistance, mutual support between paired families, group activities, and individualized feedback.
The intervention will be delivered through community-based sessions and supported home activities by trained researchers and community nurses.
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Comparador activo: Routine Community Care
Participants will receive routine community care, including standard health education and usual community-based health services, during the 8-week study period.
They will not receive the community-family mutual support intervention.
|
Participants will receive routine community care, including standard health education and usual community-based health services, during the 8-week study period.
They will not receive the community-family mutual support intervention.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Change in Cognitive Function Assessed by the Montreal Cognitive Assessment (MoCA)
Periodo de tiempo: From enrollment to the end of treatment at 8 weeks
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From enrollment to the end of treatment at 8 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change From Baseline in Social Support Rating Scale (SSRS) Total Score
Periodo de tiempo: From enrollment to the end of treatment at 8 weeks
|
Social support will be assessed using the 10-item Social Support Rating Scale (SSRS).
The total score ranges from 12 to 66 points, with higher scores indicating greater social support.
The outcome measure is the change in the total score from baseline to Week 8.
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From enrollment to the end of treatment at 8 weeks
|
|
Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score
Periodo de tiempo: From enrollment to the end of treatment at 8 weeks
|
Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire (PHQ-9).
Each item is scored from 0 to 3, resulting in a total score ranging from 0 to 27.
Higher scores indicate more severe depressive symptoms.
The outcome measure is the change in the PHQ-9 total score from baseline to Week 8.
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From enrollment to the end of treatment at 8 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
28 de julio de 2026
Finalización primaria (Estimado)
28 de septiembre de 2026
Finalización del estudio (Estimado)
28 de octubre de 2026
Fechas de registro del estudio
Enviado por primera vez
7 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
11 de julio de 2026
Publicado por primera vez (Actual)
14 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
11 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 81251000 (Otro número de subvención/financiamiento: Biomedical Ethics Committee of Anhui Medical University)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .