Evaluating the Efficacy of a Detection and Prevention Program for Frail Community-dwelling Older Adults (D-SCOPE)
24 de abril de 2019 actualizado por: Liesbeth De Donder, Vrije Universiteit Brussel
Study Protocol of the D-SCOPE Project With a Randomized Controlled Trial, Evaluating the Efficacy of a Detection and Prevention Program for Frail Community-dwelling Older Adults
The evaluation of a detection and prevention program which aims to create a continuum of care and support for frail community-dwelling older people (from early detection, over intervention, to follow-up).
First, the program aims to develop methods to easily, accurately and timely detect and prevent a negative frailty-balance in older people.
Second, the study aims to improve the quality and efficacy of care and support given to frail community-dwelling older people.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
869
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.
Ubicaciones de estudio
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Gent, Bélgica, 9000
- OCMW Gent
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Knokke-Heist, Bélgica, 8300
- OCMW Knokke-Heist
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Tienen, Bélgica, 3300
- OCMW Tienen
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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
60 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
Sample 1: 150 older people per municipality (total: 3 municipalities) (inclusion criteria: at least one selection criterion)
- Gender: 75 men - 75 women
- Age: 25 older people aged between 60 and 70 years old - 125 older people older than 70 years
- Marital status: 50 older people with partner - 100 older people without partner
- Living situation: 100 older people who have not moved last 10 years - 50 older people who have moved last 10 years
- Migration background: 100 older people born in Belgium - 50 older people born elsewhere
Sample 2: 150 older people per municipality (total: 3 municipalities) (inclusion criteria: all selection criteria at once)
- 75 men, older than 70 years, living together/widowed/divorced/never married, moved last 10 years
- 75 women, older than 70 years, widowed/divorced/never married, moved last 10 years
Exclusion Criteria:
- Current institutionalization
- Current hospitalization
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: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Risk of being frail experimental group
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Offering tailored care and support whereby the competences, strengths and resources of the older person are taken into account.The intervention will be an enhancement of usual care and will depend on the availability of the municipality, and could be formal (i.e., home care) or informal (e.g.
activities of an older adult's association).
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Sin intervención: Risk of being frail control group
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Sin intervención: No/low risk of being frail
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Sin intervención: Risk of being frail care avoiders
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline Quality of Life at 6 months
Periodo de tiempo: Assessed during baseline testing + 6 months after inclusion
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One question from the WHOQOL-BREF will be used to measure the quality of life of participants (1 item).
Older participants will also be asked to rate their quality of life on a scale from 0 to 10.
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Assessed during baseline testing + 6 months after inclusion
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Change from baseline Satisfaction with Life at 6 months
Periodo de tiempo: Assessed during baseline testing + 6 months after inclusion
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The Satisfaction with Life Scale will be administered to explore the life satisfaction of the participants (5 items)
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Assessed during baseline testing + 6 months after inclusion
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Change from baseline sense of mastery at 6 months
Periodo de tiempo: Assessed during baseline testing + 6 months after inclusion
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To assess the sense of mastery of older people, the current mastery questionnaire will be used and one self-constructed item will be added which will assess mastery in relation to others.
Older participants will also be asked to rate their mastery on a scale from 0 to 10.
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Assessed during baseline testing + 6 months after inclusion
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Change from baseline Meaning in Life at 6 months
Periodo de tiempo: Assessed during baseline testing + 6 months after inclusion
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Meaning in life will be evaluated with 5 items from the Meaning in Life Questionnaire (MLQ).
Older participants will also be asked to rate their meaning in life on a scale from 0 to 10.
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Assessed during baseline testing + 6 months after inclusion
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Change from baseline Community Inclusion at 6 months
Periodo de tiempo: Assessed during baseline testing + 6 months after inclusion
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Community inclusion will be measured using 1 item from the Community Integration Measure (CIM).
Older participants will also be asked to rate their community inclusion on a scale from 0 to 10.
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Assessed during baseline testing + 6 months after inclusion
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Change from baseline aging well in place at 6 months
Periodo de tiempo: Assessed during baseline testing + 6 months after inclusion
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One self-constructed question (1 item) will assess if the older person lives at home in a qualitative manner
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Assessed during baseline testing + 6 months after inclusion
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Multidimensional frailty
Periodo de tiempo: Assessed during baseline testing + 6 months after inclusion
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The Comprehensive Frailty Assessment Instrument (CFAI) will be used to measure multidimensional frailty: physical, cognitive, psychological, social and environmental frailty
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Assessed during baseline testing + 6 months after inclusion
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Physical phenotype of frailty
Periodo de tiempo: Assessed during baseline testing + 6 months after inclusion
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The Fried's phenotype of frailty will be used to assess the physical phenotype of frailty as well as the questionnaire of Op het Veld
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Assessed during baseline testing + 6 months after inclusion
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Feeling frail
Periodo de tiempo: Assessed during baseline testing + 6 months after inclusion
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The subjective feeling of frailty will be assessed using 1 self-constructed question and will assess to what extent an older person feels frail
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Assessed during baseline testing + 6 months after inclusion
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Resilience
Periodo de tiempo: Assessed during baseline testing + 6 months after inclusion
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Resilience will be measured using the Connor-Davidson Resilience Scale (CD-RISC2), which is an abbreviated 2-item version of the original scale
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Assessed during baseline testing + 6 months after inclusion
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Coping
Periodo de tiempo: Assessed during baseline testing + 6 months after inclusion
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Coping will be measured using 12 items from the BRIEF cope.
Two items from active coping, positive reframing, religion, use of emotional support and self-distraction and one item from acceptance and behavioral disengagement will be used
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Assessed during baseline testing + 6 months after inclusion
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Help needed for activities in daily life
Periodo de tiempo: Assessed during baseline testing + 6 months after inclusion
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Older people will be asked if they need help with 8 activities of daily life, and to what extent the help they receive for these activities is sufficient.
These questions are adapted from the questionnaire of the Belgian Ageing Studies (BAS)
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Assessed during baseline testing + 6 months after inclusion
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Informal and formal care
Periodo de tiempo: Assessed during baseline testing + 6 months after inclusion
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Older people will be asked if they receive care from 6 informal and 14 formal caregivers and if they are satisfied with the help they receive from these caregivers.
These questions are adapted from the BAS-questionnaire.
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Assessed during baseline testing + 6 months after inclusion
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Medical care
Periodo de tiempo: Assessed during baseline testing + 6 months after inclusion
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The participants will be asked if they needed to go to the hospital, to a residential setting and a rehabilitation center over the past 6 months (day case/overnight stay).
These questions are adapted from the Health Interview Survey.
In addition, the participants will be asked when they visited the general practitioner for the last time over the last 6 months.
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Assessed during baseline testing + 6 months after inclusion
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Leisure time
Periodo de tiempo: Assessed during baseline testing + 6 months after inclusion
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Leisure time will be measured by using an adapted question with 8 items derived from the BAS-questionnaire and will examine how often the participants perform the listed activities
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Assessed during baseline testing + 6 months after inclusion
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Neighborhood
Periodo de tiempo: Assessed during baseline testing + 6 months after inclusion
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Different dimensions of neighborhood will be assessed.
First, the social environment will be administered by using 3 items from the social cohesion dimension of the Neighbourhood Scale.
Second, the physical environment will be explored by using 4 items from the BAS-questionnaire as well as from the Neighbourhood Environment Walkability Scale.
Finally, low-key participation will be examined by using 2 items from the questionnaire of Oswald & Konopik.
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Assessed during baseline testing + 6 months after inclusion
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Life-events
Periodo de tiempo: Assessed during baseline testing + 6 months after inclusion
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A shortened version of the Geriatric Adverse Life Events Scale (GALES) will be adapted to assess to occurrence of life-events (11 items)
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Assessed during baseline testing + 6 months after inclusion
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Liesbeth De Donder, Prof. Dr., Vrije Universiteit Brussel
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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 (Actual)
1 de junio de 2017
Finalización primaria (Actual)
30 de abril de 2018
Finalización del estudio (Actual)
30 de junio de 2018
Fechas de registro del estudio
Enviado por primera vez
17 de mayo de 2017
Primero enviado que cumplió con los criterios de control de calidad
23 de mayo de 2017
Publicado por primera vez (Actual)
30 de mayo de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de abril de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
24 de abril de 2019
Última verificación
1 de abril de 2019
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- D-SCOPE IWT 140027
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. .
Ensayos clínicos sobre Tailored care and support
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