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Promoting Activity, Independence and Stability in Early Dementia and Mild Cognitive Impairment (PrAISED2)

20 de agosto de 2019 actualizado por: Nottingham University Hospitals NHS Trust
A clinical trial to test the clinical and cost-effectiveness of a therapy intervention designed to promote activity and independence and reduce falls, amongst people with early dementia or mild cognitive impairment

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

Background and study aims People with memory problems can struggle with everyday activities and may stop doing things they want to do. They are more prone to accidents and have a higher risk of falling. Occupational therapists can advise how to do daily activities more easily and safely. Physiotherapists can teach exercises which increase activity and improve balance, and may help maintain memory. There is little research on how to make these interventions work for with people with memory problems. The aim of this study is to compare an activity and exercise programme developed for people with memory problems to standard falls prevention assessment and advice.

Who can participate? Patients aged 65 or over with early dementia or memory problems, recruited from memory clinics or the 'Join Dementia Research' register

What does the study involve? Participants are randomly allocated to either the control group or the intervention group. The control group receive standard brief falls assessment and advice, and up to two further visits if required. The intervention group receive an assessment, tailored strength and balance exercise programme, activity analysis and risk enablement advice, and assessment for environmental hazards. The intervention is delivered over 1 year in participants' own homes, and is tailored to individual interests, abilities and need for supervision. Participants are encouraged to exercise by themselves or with family members between visits, and once the programme ends. Researchers visit at the start of the study and after 12 months to measure ability in activities of daily living, activity, quality of life, memory and health service use. Participants complete monthly falls diaries over 15 months. The researchers conduct interviews and video record some therapy sessions to help understand how the programme works in practice.

What are the possible benefits and risks of participating? Some participants may benefit from taking part in the intervention, as exercise is generally known to be beneficial to health and well-being, including benefits to heart, blood pressure, diabetes, joints, mood and daily life. These participants may find that they are better able to do their daily activities. All participants and their relatives may enjoy having the researchers coming to visit them in their house. Some people appreciate having the opportunity to contribute to the well-being of others through research.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

368

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

  • Reino Unido
    • Derbyshire
      • Derby, Derbyshire, Reino Unido, DE22 3LZ
        • Reclutamiento
        • Derbyshire healthcare NHS foundation trust
        • Contacto:
        • Contacto:
    • Lincolnshire
      • Lincoln, Lincolnshire, Reino Unido, NG34 8GG
        • Reclutamiento
        • Lincolnshire partnership NHS foundation trust
        • Contacto:
        • Contacto:
    • Notts
      • Nottingham, Notts, Reino Unido, NG3 6AA
        • Reclutamiento
        • Nottinghamshire Healthcare NHS Foundation Trust
        • Contacto:
        • Contacto:
    • Somerset
      • Bath, Somerset, Reino Unido, BA1 3NG
        • Reclutamiento
        • RICE - Research Institute for the Care of Older People
        • Contacto:
        • Contacto:

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:

  1. Age 65 or over (no maximum)
  2. Diagnosis of MCI or dementia (of any subtype, except Dementia with Lewy Bodies i.e. Parkinson's Disease Dementia)
  3. Have a carer or friend who knows the participant well (at least one hour a week contact over the phone, internet, or in person), and is willing and able to act as an informant
  4. Able to walk without human help
  5. Able to communicate in English
  6. Able to see, hear and have dexterity sufficiently to perform neuropsychological tests
  7. Have capacity to give consent to participate, and consenting to do so

Exclusion Criteria:

  1. Co-morbidity preventing participation (e.g. severe breathlessness, pain, psychosis, Parkinson's, Dementia with Lewy Bodies, or other severe neurological disease)
  2. Unavailable over the next year (e.g. plans to relocate or go on a long holiday, or has a life expectancy of less than a year)

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Control
The control group will receive standard brief falls assessment and advice.
Comparador activo: Intervention
Therapy intervention.
Conductual: Intervention
Assessment, tailored strength and balance exercise programme, activity analysis and risk enablement advice, and assessment for environmental hazards. Tailored adherence support and supervision.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Disability Assessment in Dementia (DAD)
Periodo de tiempo: 12 months

Primary outcomes will be disability in Activities of Daily Living (Disability Assessment in Dementia, DAD) measured 12 months after randomisation. This is as recommended in a recent NIHR systematic review [Webster 2017].

scale range is 0% to 100%. Where 0% = minimal functional ability and 100% maximal functional ability. Higher scores represent less disability in ADL and lower scores indicate more dysfunction. There are no subscales.

"The total score is obtained by adding the rating for each question and converting this total score out of 100. The items rated as N/A are not considered for the total score. For example:

A score of 33 on 40 (maximum score) converted out of 100 = 83% A score of 33 on 38 (max. score with 2 N/A) converted out of 100 = 87%

This will result in a final score, a percentage which provides an appreciation of global function in ADL. Higher scores represent less disability in ADL while lower scores indicate more dysfunction."
12 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Nottingham Extended ADL Scale
Periodo de tiempo: 12 months
Self-reported Activities of Daily Living (ADL) using the Nottingham Extended ADL Scale [Nouri and Lincoln 1980].
12 months
Falls Rate
Periodo de tiempo: 12 months
Falls rate in months four-15 from randomisation (defined as 'unintentionally coming to rest on the ground or at a lower level, however caused', and ascertained by monthly diary)
12 months
Quality of Life
Periodo de tiempo: 12 months
Quality of life (EQ5D3L and EQ5D5L proxy [EuroQol Group 1990]; DemQol and DemQol proxy, including Demqol-u weights [Smith 2005; Mulhern 2013])
12 months
Mood or 'Affect'
Periodo de tiempo: 12 months
Mood or 'Affect' - Hospital Anxiety and Depression Scale (HADS [Zigmond and Snaith 1983]; Apathy Evaluation Scale - AES [Marin, Biedrzycki and Firinciogullari 1991])
12 months
Physical activity
Periodo de tiempo: 12 months
Longitudinal Aging Study Amsterdam (LASA) physical activity questionnaire [Stel 2004], pedometers
12 months
Cognition
Periodo de tiempo: 12 months
three scales from CANTAB [Cambridge Cognition, 2015]; Montreal Cognitive Assessment - MoCA [Nasreddine 2005], verbal fluency (from MoCA)
12 months
Time to first fall
Periodo de tiempo: 12 months
Time to first fall (from diary)
12 months
Rate of fractures and injurious falls
Periodo de tiempo: 12 months
Rate of fractures and injurious falls (from diary)
12 months
Rate of hospital and care home admissions, and days spent in hospital
Periodo de tiempo: 12 months
Rate of hospital and care home admissions, and days spent in hospital (from diary, hospital administrative records)
12 months
Carer strain
Periodo de tiempo: 12 months
Carer strain (Carergiver Strain Index [Robinson 1983]).
12 months
Carer health-related quality of life
Periodo de tiempo: 12 months
Carer health-related quality of life (EQ5D-5L [EuroQol Group 1990])
12 months
Personality
Periodo de tiempo: 12 months
Personality (Big Five Personality Inventory- short [BFI-10, Rammstedt and John 2007])
12 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Nottingham University Hospitals NHS Trust

Colaboradores

National Institute for Health Research, United Kingdom

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.

Enlaces Útiles

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 octubre de 2018

Finalización primaria (Anticipado)

31 de marzo de 2021

Finalización del estudio (Anticipado)

13 de marzo de 2022

Fechas de registro del estudio

Enviado por primera vez

21 de mayo de 2019

Primero enviado que cumplió con los criterios de control de calidad

20 de agosto de 2019

Publicado por primera vez (Actual)

22 de agosto de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de agosto de 2019

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

20 de agosto de 2019

Última verificación

1 de agosto de 2019

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 17HC006

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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. .

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