Telephone-Coached Sleep Bibliotherapy for Dementia Caregivers
Telephone-Coached Sleep Bibliotherapy for Informal Caregivers of People With Dementia: A Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study is a two-arm randomized controlled trial designed to evaluate the effectiveness of telephone-coached sleep bibliotherapy for informal caregivers of people with dementia.
A total of 120 eligible caregivers will be recruited and randomly assigned to either the intervention group or the control group. The intervention group will receive an 8-week telephone-coached sleep bibliotherapy program.
The control group will receive an educational booklet containing general health information and weekly check-in calls. Both groups will continue receiving usual community services.
Data will be collected at baseline, immediately after the intervention, and 3 months after the intervention. The primary outcome is sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes include caregiving appraisal, dysfunctional beliefs and attitudes about sleep, emotional distress, neuropsyatric symptoms of care recipients, and quality of life.
The findings will provide evidence regarding the effectiveness of a low-cost and easily disseminated intervention for improving sleep and well-being among caregivers of people with dementia.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Shanshan WANG, PhD
- Número de teléfono: +852 2766 4696
- Correo electrónico: shan-shan.wang@polyu.edu.hk
Copia de seguridad de contactos de estudio
- Nombre: Mingyue HU, PhD
- Número de teléfono: +852 54131253
Ubicaciones de estudio
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Kowloon
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Hung Hom, Kowloon, Hong Kong
- Reclutamiento
- The Hong Kong Polytechnic University
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Contacto:
- Shanshan Wang
- Número de teléfono: 68421201
- Correo electrónico: shan-shan.wang@polyu.edu.hk
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion criteria: a) aged 18 years or older; b) provide unpaid care to a family member with dementia; c) living with the patient or actively involved in the patient's care daily for a minimum of 4 hours/day for at least 6 months; d) endorse one or more sleep problems; e) having the sleep problem with an average of 3 or more nights per week during the past month; d) taking no medication for sleep or stabilized on current medication for at least 6 weeks; e) could be contacted by phone.
Exclusion criteria: a) report a prior diagnosis of primary sleep disorder (e.g., sleep apnoea); b) have a severe chronic illness that could cause their sleep problems (e.g., emphysema); c) receive medical, psychological, or psychiatric treatment for sleep disturbance or depression; d) have cognitive impairment; e) be included in another interventional study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Telephone-Coached Sleep Bibliotherapy
Participants receive an 8-week sleep bibliotherapy program consisting of a sleep bibliotherapy manual, cartoon videos, and weekly telephone coaching.
The intervention integrates dementia caregiving education with behavioral and cognitive strategies for improving sleep.
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An 8-week behavioral intervention consisting of a sleep bibliotherapy manual, cartoon videos, and weekly telephone coaching.
The intervention integrates dementia caregiving education with behavioral and cognitive strategies to improve sleep among informal caregivers of people with dementia.
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Comparador activo: Educational Booklet
Participants receive an educational booklet containing general health information and weekly check-in telephone calls.
The booklet does not include therapeutic sleep intervention components.
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Participants receive an educational booklet containing general health information and weekly check-in telephone calls.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Sleep Quality
Periodo de tiempo: Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
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Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI).
Higher scores indicate poorer sleep quality.
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Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Caregiving Appraisal
Periodo de tiempo: Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
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The Chinese version of the Caregiving Appraisal Scale will be used.
This is a 5-point Likert scale with 26 items and four subscales (caregiving satisfaction, caregiving mastery, subjective caregiving burden, and caregiving impact).
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Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
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Dysfunctional beliefs and attitudes about sleep
Periodo de tiempo: Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
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It will be measured using the Chinse version of 16-item Dysfunctional Beliefs and Attitudes about Sleep scale (DBAS-16).
DBAS-16 is a 16-item scale.
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Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
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Emotional distress
Periodo de tiempo: Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
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It will be measured with the stress, anxiety, and depression scales (DASS-21).
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Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
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Patient neuropsychiatric symptoms
Periodo de tiempo: Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
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The Neuropsychiatric Inventory (NPI) will be used to measure neuropsychiatric symptoms.
NPI evaluates 12 common neuropsychiatric disturbances in dementia.
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Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
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Dyadic quality of life
Periodo de tiempo: Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
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It will be measured with the Quality of Life-Alzheimer's Disease Scale (QOL-AD), which will be separately rated by caregivers and care recipients.
It is a 13-item, 4-point Likert scale that measures the quality of life for adults w
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Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
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Colaboradores e Investigadores
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Más información
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Otros números de identificación del estudio
- P0057423
Plan de datos de participantes individuales (IPD)
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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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