- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07691411
An Ecological Momentary Assessment Based Program to Support Self-Management for Post-stroke Patients
Combining Machine Learning and Ecological Momentary Assessment of Depression, Cognitive Function and Daily Activity Behavior to Support Self-Management for Post-stroke Patients: A Feasibility Study
The goal of this feasibility study is to test whether a new approach that combines real-time symptom tracking (Ecological Momentary Assessment) with machine learning can help people recovering from a stroke to better manage depression, thinking difficulties, and daily functioning. The main questions it aims to answer are:
Is this combined approach practical and acceptable for post-stroke survivors? Does the program improve mood, cognitive function, or functional ability to carry out daily activities?
Participants will:
Use a smartphone app called RehabCare Companion for a period of time Answer brief daily surveys about their mood, thoughts, and activities for one week Receive personalized self-care suggestions generated by machine learning based on their responses Complete assessments of depression, cognition, and functioning before and after the program Take part in a group interview to share their experiences
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Arkers KC Prof. Wong, PhD
- Número de teléfono: +852 34003805
- Correo electrónico: arkers.wong@polyu.edu.hk
Copia de seguridad de contactos de estudio
- Nombre: Nuo Dr. Shi, DHSc
- Número de teléfono: +852 34008172
- Correo electrónico: nuo-catherine.shi@polyu.edu.hk
Ubicaciones de estudio
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Hong Kong
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Hong Kong, Hong Kong, Hong Kong, 999077
- Reclutamiento
- Queen Elizabeth Hospital
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Contacto:
- Vivian WY Ms. Kwok
- Número de teléfono: +852 34003805
- Correo electrónico: arkers.wong@polyu.edu.hk
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- adults aged 18 years or older
- having a confirmed diagnosis of stroke
- having sufficient proficiency in Cantonese to understand and respond to the assessments and prompts
- having a Hong Kong version of the Montreal Cognitive Assessment (HK-MoCA) score of 18 or higher
- having a smartphone.
Exclusion Criteria:
- they have moderate to severe cognitive impairment (a HK-MoCA score of 17 or lower)
- they have active psychiatric disorders other than depression (e.g., schizophrenia, bipolar disorder)
- they have a terminal illness or prognosis that suggests a limited life expectancy
- they have conditions that compromise their self-care ability (i.e., bedbound).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Ecological Momentary Assessment based Self-management Program
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The research team collects participants' EMA data (ie., depression, cognitive function, daily activity, and contextual data) from participants for 7-day and analyze the data by machine learning in the first phase, while provide real-time, individualized, self-care messages to the participants via a personalized self-care AI app in the second phase.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility of the study: acceptance
Periodo de tiempo: Immediately after the intervention (T2).
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The acceptance of participants to the program will be measured by recruitment rate, attrition rate, and retention rate.
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Immediately after the intervention (T2).
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Feasibility of the study: adherence
Periodo de tiempo: Immediately after the intervention (T2).
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The adherence of the participants will be evaluated by using the percentage of completed EMA assessments and the frequency of app usage.
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Immediately after the intervention (T2).
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Feasibility of the study: experience of the participants in using the app
Periodo de tiempo: Immediately after the intervention (T2).
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Participants' experience will be assessed through individual interviews.
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Immediately after the intervention (T2).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Preliminary effectiveness: depression Levels
Periodo de tiempo: Pre-intervention (T1) and immediately after the intervention (T2).
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Beck Depression Inventory (BDI) will be used to assess the depression levels of post-stroke patients.
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Pre-intervention (T1) and immediately after the intervention (T2).
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Preliminary effectiveness: cognitive function
Periodo de tiempo: Pre-intervention (T1) and immediately after the intervention (T2).
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Cognitive function will be screened using Montreal Cognitive Assessment Hong Kong version (HK-MoCA).
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Pre-intervention (T1) and immediately after the intervention (T2).
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Preliminary effectiveness: disability and functioning
Periodo de tiempo: Pre-intervention (T1) and immediately after the intervention (T2).
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The World Health Organization Disability Assessment Schedule (WHODAS 2.0) is a widely used instrument for assessing disability and functioning in individuals.
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Pre-intervention (T1) and immediately after the intervention (T2).
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Arkers KC Wong, PhD, The Hong Kong Polytechnic University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- WZ8L
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.
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