- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07826663
Telephone-Coached Sleep Bibliotherapy for Dementia Caregivers
Telephone-Coached Sleep Bibliotherapy for Informal Caregivers of People With Dementia: A Randomized Controlled Trial
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Shanshan WANG, PhD
- Numero di telefono: +852 2766 4696
- Email: shan-shan.wang@polyu.edu.hk
Backup dei contatti dello studio
- Nome: Mingyue HU, PhD
- Numero di telefono: +852 54131253
Luoghi di studio
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Kowloon
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Hung Hom, Kowloon, Hong Kong
- Reclutamento
- The Hong Kong Polytechnic University
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Contatto:
- Shanshan Wang
- Numero di telefono: 68421201
- Email: shan-shan.wang@polyu.edu.hk
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Sleep Quality
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Caregiving Appraisal
Lasso di tempo: Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
|
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
Lasso di tempo: Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
|
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Pubblicazioni e link utili
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- P0057423
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .