Persona-Ambiente apto para personas con demencia
Mejora del ajuste persona-ambiente de los adultos mayores con demencia que residen en la comunidad
This trial will assess feasibility of a non-pharmacological intervention for persons living with Alzheimer's disease and related dementias (ADRD) to improve behavioral and psychiatric symptoms of dementia and functional performance.
Using a two-arm, prospective randomized controlled trial, 38 dyads (person with ADRD and caregiver) will complete an 8-week telehealth occupational therapy intervention provided via Zoom with caregivers and persons with dementia or receive an active control with 8 telehealth sessions to discuss publicly available caregiver education with a non-clinical research assistant.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40536
- University of Kentucky
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria: Participants with Dementia
- Men or women aged 60-99, inclusive.
- Living at home in the community with one primary caregiver.
- Diagnosis or probably diagnosis of dementia (confirmed by Clinical Dementia Rating Scale score of 1.0+)
- If on psychotropic medication, they are at a point where dosage and treatment are stabilized for the duration of the study.
- Functional sensory abilities with or without aids (hearing, vision, smell, touch, taste)
- Caregiver report of challenges related to behaviors within 4 weeks of study enrollment.
- Caregiver willing to participate throughout duration of study.
- Contact with University of Kentucky Alzheimer's Disease Research Center or Kentucky Neuroscience Institute medical provider within 12 months of study recruitment.
Inclusion Criteria: Caregiver for Participants with Dementia
- Men or women aged 21-99, inclusive.
- Willingness to participate in study and implement recommended data collection tools.
- English speaking, able to read and write.
- Ability to retrieve and send mail.
Exclusion Criteria: Participants with Dementia
- Unstable medical conditions within one month prior to screening visit such as poorly controlled blood pressure, diabetes, current cancer diagnosis, or breathing problems, etc.
- Wheelchair or bed bound.
- Residence in skilled nursing facility or facility-based care.
- Caregiver report of physically violent behaviors.
- Initiation of antipsychotic medication within 4 weeks prior to screening or unpredictable use of such medications
- Diagnosis of profound or total sensory altering disorders including macular degeneration, legal blindness, total deafness, severe peripheral neuropathy, anosmia.
- Major depression in past 12 months (DSM-IV criteria), major mental illness such as schizophrenia, bipolar disorder, personality disorders, or recent (in past 12 months) alcohol or substance abuse.
- Major infection within 4 weeks prior to the Baseline Visit.
Exclusion Criteria: Caregiver for Participant with Dementia:
• Diagnosis of mild cognitive impairment or dementia.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Harmony
Participants in this group will receive the Harmony intervention. |
The Harmony intervention builds on prior successful foundations of dementia care interventions with a novel approach combining remote implementation, antecedent education, and home environment intervention. The intervention will teach caregivers how to 1) assess the home environment as an antecedent to behavior for the person with ADRD, and 2) design and implement individualized environmental modification through an environmental cueing approach to address the needs of the person with ADRD in a supportive environment. |
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Comparador activo: National Institute on Aging Program
Participants in this group will receive the National Institute on Aging education. |
Standard of care will address behaviors and psychiatric symptoms of dementia (BPSD) for persons with ADRD, as recommended by their medical provider. Caregivers will receive training regarding home safety via a home safety handout based on National Institutes on Aging "Home Safety and Alzheimer's Disease" webpage. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Patient Performance as Measured by Canadian Occupational Performance Measure (COPM)
Periodo de tiempo: Baseline to 13 Week Follow-Up
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Criterion-referenced interview of patient performance with caregiver The COPM is a reliable and validated measure of performance in primary daily activities (self-care, leisure, productivity) with dyad-caregiver rated of performance and satisfaction. Scores are determined on a likert scale of 1-10 with 1 being lowest and 10 indicating highest of the topic of the question. |
Baseline to 13 Week Follow-Up
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Caregiver Satisfaction of Patient Performance [Feasibility]
Periodo de tiempo: Baseline to 13 Week Follow-Up
|
The primary outcome analysis is the feasibility of implementation as measured by caregiver satisfaction. The Canadian Occupational Performance Measure will measure caregiver satisfaction of patient performance, high scores indicate higher levels of satisfaction. Range 0-10. |
Baseline to 13 Week Follow-Up
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Zarit Caregiver Burden Scale
Periodo de tiempo: Baseline to 13 Week Follow-Up
|
22-item survey, caregiver rates self-perceived level of burden on 5-point Likert scale. The social context of the person with ADRD will be described through analysis of caregiver demographics and rate of caregiver burden measured. Higher scores indicate greater burden. Range of 0-88 points. A score of 17 or more was considered high burden. |
Baseline to 13 Week Follow-Up
|
|
Neuropsychiatric Inventory Questionnaire (NPI-Q)
Periodo de tiempo: Baseline to 13 Week Follow-Up
|
The NPI-Q is commonly used as an assessment of behavioral and psychiatric symptoms of dementia in older adults diagnosed with mild cognitive impairment or dementia, internationally, with high reliability and validity. Assessment includes 12 behavioral and psychiatric domains which are rated by caregiver as present or absent (yes/no). Caregivers further rate severity of present behavioral domains. The severity score is summed to yield a total as a measure of BPSD burden. Higher scores indicate higher levels of behavior symptom severity and/or distress. Range 0-36 |
Baseline to 13 Week Follow-Up
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Functional Behavior Profile (FBP)
Periodo de tiempo: Baseline to 13 Week Follow-Up
|
Criterion-referenced survey completed by caregiver. The FBP has been established as a reliable and valid measure of task performance, social interaction, and problem solving with adults with ADRD. The FBP consists of 27 items rated from 0 to 4, with higher scores indicating better performance. The total score ranges from 0 to 108. The FBP includes three subscales: Task Performance (0-36), Social Interaction (0-24) and Problem Solving (0-48). Subscale scores are summed to calculate the total FBP score. |
Baseline to 13 Week Follow-Up
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Elizabeth Rhodus, PhD, University of Kentucky
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (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
- 72893
- 1K23AG075262-01A1 (Subvención/contrato del NIH de EE. UU.)
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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