Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Comprehensive Intervention for Falls Prevention in the Elderly

20 de abril de 2016 actualizado por: Yan Press, Soroka University Medical Center
The purpose of this study is to determine whether the comprehensive multidisciplinary intervention (geriatrician, physical therapist and occupational therapist falls risk assessment and intervention)is effective in the falls prevention in the community dwelling elderly.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

Falls and related injuries among elderly people are a major public health problem worldwide.All older people with recurrent falls or assessed as being at increased risk of falling should be considered for an individualized multifactorial intervention.

In successful multifactorial intervention programmes the following specific components are common - against a background of the general diagnosis and management of causes and recognized risk factors:

  • exercise
  • home hazard assessment and intervention
  • vision assessment and referral
  • medications list review with modification/withdrawal We will address to 4000 randomly chosen patients from study population (elderly (65+) men and women, living in Beer-Sheva and Ofakim , Israel and belonging to Clalit HMO). This telephone interview will be conducted to reveal falls in last 12 months. The people who do fall (1 + falls) will be invited to research assistant.

In that meeting the research assistant will explain about the study aims and ask them to sign informed consent. Those who do not agree to participate - will be referred to their family doctor for further assessment.

Those who agree to participate in the study will fill in questionnaire about falls (causes, circumstance, results). All will pass through: cognitive assessment by the Mini-Mental State Examination (MMSE), affective assessment by the 15-item Geriatric Depression Scale (GDS), functional assessment by Barthel Index (BI), visual assessment by Snellen charts and basic gait assessment by a "Timed get Up and Go" test (TU&G).

Participants that fulfill inclusion criteria will be randomly assigned to the intervention group or the control group. All participants will be instructed to call to the research assistant closely to each fall.

All information about assessment of patients in both groups will be transferred to the family physician. Their family physician according to his opinion will treat patients from usual care group.

A geriatrician, physiotherapist and occupational therapist will observe patients in the intervention group. OT will conduct a home visit to assess hazard and level of risk factor for falling. Results of assessment will be discussed on multi- disciplinary team meeting.

According to this plan each patient in this group will receive one or more following interventions:

  1. Written recommendation to the family physician for medication adjustment. As well, the geriatrician will discuss with family physician these recommendations.
  2. Recommendation to the family physician to refer the patient to optometrist/ ophthalmologist.
  3. Physical therapy: each subject in intervention group will get 15 weekly sessions (each session - 45 minutes) of specified exercise from a physical therapist that specializes in fall prevention and walking device recommendations. All subjects will get brochure for home exercise. It will be expected for intervention group to exercise twice daily, each time for 20 minutes in addition to the PT sessions.
  4. Occupational therapy: OT will make recommendation for changing any unsafe environments in the home.

First follow-up (four months after baseline assessment):

  1. OT will make a second home visit to each subject of the intervention group to check recommendation fulfillment.
  2. Study assistant will repeat baseline assessment (MMSE, GDS, BI, TU&G and visual assessment by Snellen chart).
  3. Information about falls and injuries as well as health care utilization will be collected from Clalit computerized system and Soroka Medical Center data base.
  4. Information about medication adjustment and changes will be collected from Clalit computerized system.

Second follow-up (12 months after baseline assessment ) :

  1. Study assistant will repeat baseline assessment (MMSE, GDS, BI, TUG test and visual assessment by Snellen chart).
  2. Information about falls and injuries as well as health care utilization will be collected from Clalit computerized system and Soroka Medical Center data base.
  3. Information about medication adjustment and changes will be collected from Clalit computerized system.

Tipo de estudio

Intervencionista

Inscripción (Actual)

8

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

      • Beer- Sheva, Israel
        • Department of Family Medicine, Faculty of Health Sciences, Ben Gurion University of the Negev

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

65 años y mayores (Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Living in Beer Sheva or Ofakim , Israel
  • Members of Clalit HMO
  • 1 or more falls in past 12 month (self-reported)
  • Age 65 or more
  • Mobile outdoors without wheelchair

Exclusion Criteria:

  • Seriously ill patients - as dyspnea with light exercise, unstable heart disease
  • MMSE less than 18

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: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Intrevention group
each subject in intervention group will get 15 weekly sessions (each session - 45 minutes) of specified exercise from a physical therapist that specializes in fall prevention and walking device recommendations. All subjects will get brochure for home exercise. It will be expected for intervention group to exercise twice daily, each time for 20 minutes in addition to the PT sessions
Comprehensive Multidisciplinary Intervention
Sin intervención: Control group

Those who agree to participate in the study will fill in questionnaire about falls (causes, circumstance, results). All will pass through: cognitive assessment by the Mini-Mental State Examination (MMSE), affective assessment by the 15-item Geriatric Depression Scale (GDS), functional assessment by Barthel Index (BI), visual assessment by Snellen charts and basic gait assessment by a "Timed get Up and Go" test (TU&G).

Participants that fulfill inclusion criteria will be randomly assigned to the intervention group or the control group

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
number of falls
Periodo de tiempo: 4 and 12 monthes
4 and 12 monthes

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este 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

1 de abril de 2008

Finalización primaria (Actual)

1 de junio de 2011

Finalización del estudio (Actual)

1 de junio de 2011

Fechas de registro del estudio

Enviado por primera vez

19 de diciembre de 2006

Primero enviado que cumplió con los criterios de control de calidad

19 de diciembre de 2006

Publicado por primera vez (Estimar)

20 de diciembre de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

21 de abril de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

20 de abril de 2016

Última verificación

1 de diciembre de 2006

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • sor444506ctil

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 Caídas Accidentales

Ensayos clínicos sobre Comprehensive Multidisciplinary Intervention

3
Suscribir