- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02044783
Identifying and Treating Physical Function Impairment in Elders
Sedentary older adults are more likely to develop physical function impairments than active older adults. Physical function measured by slow usual gait speed predicts the risk of future falls, disability, institutionalization and mortality. Behavioral physical activity interventions have improved physical activity and physical function, but have not generally been implemented where they may have the most impact -- primary care settings. In part, this is due to the limited time and training for clinical staff to screen for physical function impairment and to treat with physical activity counseling. The proposed scientific goal is to overcome these barriers by adapting an evidence-based screening tool and telephone-based physical activity intervention into primary care settings.
Aim1: Among older adults who screen positive for physical function impairment, to determine the estimated intervention effect size of a 12-week behavioral intervention on physical activity and physical function.
Hypothesis 1a: Physical activity levels will increase more in the intervention vs. usual care group.
Hypothesis 1b: Physical function will increase more in the intervention vs. usual care group.
Aim 2: Among Aim 1 participants and clinical staff who deliver the functional screening and Aim 1 intervention, to evaluate standard implementation science process metrics of reach, acceptability, and implementation
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Colorado
-
Aurora, Colorado, Estados Unidos, 80045
- University of Colorado Anschutz Medical Campus
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Sedentary patients aged 65-85 years who screen positive for physical function impairment (Physical function impairment includes any of the following: time to complete 4-meter walk ≥4.82 seconds (i.e., ≥0.83 meters/second); a reported fall in the past 3 months; or a reported fear of falling)
Exclusion Criteria:
- Inability to walk ≥30 feet without human assistance7
- Dementia, as assessed by either a Folstein Mini-Mental Status Examination <24 or by patient's primary care provider's assessment
- Severe vision loss (legally blind)
- Severe hearing loss
- Medical condition that precludes increasing physical activity per primary care provider's assessment
- Terminal diagnosis per primary care provider's assessment
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Behavioral Intervention
Behavioral Counseling Intervention: 6 telephone calls that include physical activity goal-setting, tracking,and problem-solving of barriers
|
|
Sin intervención: Usual Care
Monthly mailed print materials on aging topics (that would generally be administered by subjects' primary care clinic).
No behavioral counseling.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Changes in physical activity as determined by accelerometer
Periodo de tiempo: 12 weeks
|
Subjects' physical activity levels will be determined by accelerometer measures during week 1 and after a 12-week behavioral intervention.
|
12 weeks
|
Changes in physical function as assessed by 400-meter walk speed
Periodo de tiempo: 12 weeks
|
Subjects' physical function will be assessed by 400-meter walk speed before and after 12-week behavioral intervention.
|
12 weeks
|
Changes in physical function as assessed by Short Physical Performance Battery
Periodo de tiempo: 12 weeks
|
Subjects' physical function will be assessed by the Short Physical Performance Battery before and after a 12-week intervention
|
12 weeks
|
Change in physical function as assessed by lower extremity strength testing
Periodo de tiempo: 12 weeks
|
Subjects' physical function will be assessed by lower extremity strength testing before and after a 12-week behavioral intervention .
|
12 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Evaluation of standard implementation science process of reach
Periodo de tiempo: 1 year
|
Reach is the percent of patients consented divided by the number eligible.
|
1 year
|
Assessment of standard implementation science process metrics of acceptability
Periodo de tiempo: 1 year
|
Acceptability will be assessed through structured surveys.
|
1 year
|
Assessment of standard implementation science process metrics of implementation
Periodo de tiempo: 1 year
|
Implementation process will be assessed by structured surveys
|
1 year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Amy Huebschmann, MD, University of Colorado - Anschutz Medical Campus
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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
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 Consejería conductual
-
University of OxfordOxford University Hospitals NHS TrustDesconocidoSíntomas de comportamientoReino Unido
-
The University of Hong KongTerminadoGrupo de paresPorcelana
-
QuironsaludTerminado
-
Assistance Publique - Hôpitaux de ParisAún no reclutandoPérdida de la audición | Función cognitiva | Función ejecutiva | Función vestibularFrancia
-
Unity Health TorontoActivo, no reclutando
-
Square2 Systems, Inc.National Institute on Drug Abuse (NIDA)ReclutamientoTrastornos relacionados con sustancias | Trastornos por uso de sustanciasEstados Unidos
-
Virginia Polytechnic Institute and State UniversityCarilion Clinic; Thomas Jefferson University; Drexel University; Mazzoni Health Center y otros colaboradoresActivo, no reclutandoSuicidio | Compromiso, PacienteEstados Unidos
-
Network for Engineering and Economics Research...TerminadoAnticoncepción | Anemia por deficiencia de hierro del embarazo | Cuidado prenatal | Atención posnatalIndia
-
Washington University School of MedicineUniversity of Colorado, Denver; University of California, Berkeley; University... y otros colaboradoresActivo, no reclutando