- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07826663
Telephone-Coached Sleep Bibliotherapy for Dementia Caregivers
Telephone-Coached Sleep Bibliotherapy for Informal Caregivers of People With Dementia: A Randomized Controlled Trial
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Shanshan WANG, PhD
- Telefoonnummer: +852 2766 4696
- E-mail: shan-shan.wang@polyu.edu.hk
Studie Contact Back-up
- Naam: Mingyue HU, PhD
- Telefoonnummer: +852 54131253
Studie Locaties
-
-
Kowloon
-
Hung Hom, Kowloon, Hongkong
- Werving
- The Hong Kong Polytechnic University
-
Contact:
- Shanshan Wang
- Telefoonnummer: 68421201
- E-mail: shan-shan.wang@polyu.edu.hk
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
|
Actieve vergelijker: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Sleep Quality
Tijdsspanne: 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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Caregiving Appraisal
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- P0057423
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .