Telephone-Coached Sleep Bibliotherapy for Dementia Caregivers
Telephone-Coached Sleep Bibliotherapy for Informal Caregivers of People With Dementia: A Randomized Controlled Trial
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Shanshan WANG, PhD
- Telefonnummer: +852 2766 4696
- E-post: shan-shan.wang@polyu.edu.hk
Studera Kontakt Backup
- Namn: Mingyue HU, PhD
- Telefonnummer: +852 54131253
Studieorter
-
-
Kowloon
-
Hung Hom, Kowloon, Hong Kong
- Rekrytering
- The Hong Kong Polytechnic University
-
Kontakt:
- Shanshan Wang
- Telefonnummer: 68421201
- E-post: shan-shan.wang@polyu.edu.hk
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
|
|
Aktiv 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.
|
Participants receive an educational booklet containing general health information and weekly check-in telephone calls.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Sleep Quality
Tidsram: 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.
|
Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Caregiving Appraisal
Tidsram: 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).
|
Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
|
|
Dysfunctional beliefs and attitudes about sleep
Tidsram: 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.
|
Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
|
|
Emotional distress
Tidsram: Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
|
It will be measured with the stress, anxiety, and depression scales (DASS-21).
|
Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
|
|
Patient neuropsychiatric symptoms
Tidsram: Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
|
The Neuropsychiatric Inventory (NPI) will be used to measure neuropsychiatric symptoms.
NPI evaluates 12 common neuropsychiatric disturbances in dementia.
|
Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
|
|
Dyadic quality of life
Tidsram: Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
|
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
|
Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- P0057423
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .