- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07933731
Evaluating ICF-Based Case Management in Adults With Intellectual Disabilities
Effectiveness of ICF-based Case Management in Promoting Independence and Vocational Participation Among Adults With Intellectual Disabilities: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate whether an ICF-based interdisciplinary case management model can improve adaptive functioning, functioning and participation, and vocational functioning among adults aged 18 to 60 years with mild to moderate intellectual disabilities receiving residential care or vocational rehabilitation services in Hong Kong. The main questions it aims to answer are:
- Does ICF-based interdisciplinary case management lead to greater improvements in adaptive functioning, as measured by the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3), compared with conventional multidisciplinary rehabilitation care?
- Does ICF-based interdisciplinary case management improve functioning and participation outcomes across relevant ICF domains compared with conventional multidisciplinary rehabilitation care?
- Among participants receiving vocational rehabilitation services, does the intervention improve vocational functioning and work-related behaviours compared with conventional multidisciplinary rehabilitation care?
Researchers will compare participants receiving ICF-based interdisciplinary case management with those receiving conventional multidisciplinary rehabilitation care to determine whether the ICF-based approach produces better outcomes in adaptive functioning, functioning and participation, and vocational functioning.
Participants will:
- Complete baseline and post-intervention assessments over a 6-month study period.
- Be randomly assigned to either the ICF-based case management group or the conventional care group.
- Receive rehabilitation services from multidisciplinary professionals.
- If assigned to the intervention group, undergo ICF-based assessment, interdisciplinary goal setting, case conferences, and coordinated rehabilitation planning guided by the ICF Rehab-Cycle®.
- Complete outcome evaluations using the Vineland-3, WHO ICF Checklist v2.1a, and, where applicable, the Chinese Work Personality Profile (CWPP).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Adults with intellectual disabilities often experience complex and interrelated challenges in adaptive functioning, participation, and community integration that require coordinated interdisciplinary rehabilitation. The World Health Organization's International Classification of Functioning, Disability and Health (ICF) provides a biopsychosocial framework for understanding functioning and disability and facilitates communication, goal setting, and collaborative care planning among rehabilitation professionals.
This randomized controlled trial aims to evaluate the effectiveness of an ICF-based interdisciplinary case management model for adults with intellectual disabilities receiving residential care or vocational rehabilitation services. Participants will be randomly allocated to either an ICF-based interdisciplinary case management group or a conventional multidisciplinary rehabilitation care group and followed for six months.
The intervention is guided by the ICF Rehab-Cycle®, which comprises four key processes: assessment, assignment, intervention, and evaluation. Using the ICF framework, interdisciplinary team members will conduct a comprehensive assessment of participants' body functions, activities, participation, environmental factors, and personal factors. Assessment findings will be used to develop a shared understanding of each participant's functioning profile and to formulate individualized rehabilitation goals through interdisciplinary case conferences. These goals will guide coordinated intervention planning and service delivery. Participants' progress and goal attainment will be reviewed regularly, and intervention strategies will be adjusted according to changes in functioning and participation throughout the rehabilitation process.
Participants in the control group will receive routine multidisciplinary rehabilitation services according to existing service practices without the use of a structured ICF-based case management framework.
The findings will provide evidence regarding the clinical effectiveness and feasibility of implementing an ICF-based interdisciplinary case management approach in intellectual disability rehabilitation services and may inform future service development, interdisciplinary practice, and the application of the ICF framework in rehabilitation settings.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Man Hei Ling, MPsyMed
- Número de teléfono: +852 35250898
- Correo electrónico: lingmanheioliver@gmail.com
Ubicaciones de estudio
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Hong Kong, Hong Kong, 999077
- Po Leung Kuk Lau Chan Siu Po Integrated Rehabilitation Centre
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Contacto:
- Man Hei Ling, MPsyMed
- Número de teléfono: +852 35250898
- Correo electrónico: lingmanheioliver@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
To be eligible for participation, individuals must:
- be aged between 18 and 60 years;
- have a formal medical diagnosis of mild or moderate intellectual disability;
- be currently receiving residential care or vocational rehabilitation services;
- be medically stable and able to participate in routine rehabilitation programmes; and
- provide informed consent directly or via a legally authorized representative.
Individuals will be excluded if they:
- experience an acute or unstable medical condition requiring intensive treatment;
- present with acute psychiatric episodes that may substantially interfere with participation;
- are currently participating in ICF-Based Interdisciplinary Case Management Programme; or
- lack an available consent pathway through either personal consent or legal representation.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: ICF-Based Interdisciplinary Case Management
Participants will receive rehabilitation services coordinated using the International Classification of Functioning, Disability and Health (ICF) framework. The intervention includes standardized ICF-based assessment, interdisciplinary case conferences, collaborative goal setting, individualized rehabilitation planning, and coordinated intervention delivery by multidisciplinary team members over a 6-month period. Outcomes are monitored and reviewed according to participants' functioning, participation, environmental, and personal factors. |
A structured case management model utilizing the ICF framework to guide assessment, goal setting, intervention planning, and interdisciplinary collaboration for adults with intellectual disabilities receiving rehabilitation services. |
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Comparador activo: Conventional Multidisciplinary Rehabilitation Care
Participants will receive usual rehabilitation services provided by multidisciplinary professionals according to existing service practices. Assessment, goal setting, and intervention planning will be conducted in accordance with routine procedures without the use of a structured ICF-based case management framework. |
Standard rehabilitation services delivered by multidisciplinary professionals, including discipline-specific assessment, rehabilitation planning, and intervention based on existing service protocols. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Adaptive Functioning
Periodo de tiempo: Baseline and 6 months (post-intervention)
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Adaptive functioning measured by the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3). The Vineland-3 assesses participants' adaptive behavior across domains including communication, daily living skills, and socialization. Change in scores from baseline to 6 months will be compared between the intervention and control groups. |
Baseline and 6 months (post-intervention)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Functioning and Participation
Periodo de tiempo: Baseline and 6 months post-intervention.
|
Functioning and participation measured using the WHO ICF Checklist Version 2.1a. The assessment evaluates functioning across body functions, activities and participation, environmental factors, and personal factors. Changes from baseline to 6 months will be compared between groups. |
Baseline and 6 months post-intervention.
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Vocational Functioning
Periodo de tiempo: Baseline and 6 months post-intervention.
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Vocational functioning measured using the Chinese Work Personality Profile (CWPP). The assessment evaluates work-related behaviors and vocational performance among participants receiving vocational rehabilitation services. Changes from baseline to 6 months will be compared between groups. |
Baseline and 6 months post-intervention.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
- PLK/REC/2026/01
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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