- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07826663
Telephone-Coached Sleep Bibliotherapy for Dementia Caregivers
Telephone-Coached Sleep Bibliotherapy for Informal Caregivers of People With Dementia: A Randomized Controlled Trial
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Shanshan WANG, PhD
- Numer telefonu: +852 2766 4696
- E-mail: shan-shan.wang@polyu.edu.hk
Kopia zapasowa kontaktu do badania
- Nazwa: Mingyue HU, PhD
- Numer telefonu: +852 54131253
Lokalizacje studiów
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Kowloon
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Hung Hom, Kowloon, Hongkong
- Rekrutacyjny
- The Hong Kong Polytechnic University
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Kontakt:
- Shanshan Wang
- Numer telefonu: 68421201
- E-mail: shan-shan.wang@polyu.edu.hk
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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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Aktywny komparator: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Sleep Quality
Ramy czasowe: Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
|
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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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Caregiving Appraisal
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- P0057423
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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