An interventional study of Telephone-Coached Sleep Bibliotherapy and Educational Booklet in Sleep Disturbance and Dementia, sponsored by The Hong Kong Polytechnic University. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Supportive care
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Among 32 studies in Dementia by The Hong Kong Polytechnic University — 13 open to participants now, 13 under way, none of them phase 3. Dementia · The Hong Kong Polytechnic University.
Among the 32 studies in Dementia by The Hong Kong Polytechnic University, this one is the 8th largest by planned enrollment, is one of 3 that started in 2026, is one of 31 with no phase, reaches primary completion later than 12 of the 12 other live ones, and was the 31st registered.
2,373 studies on the registry are indexed under Dementia; 574 are open to participants now.
Browse Dementia studies →13 of the 32 studies in Dementia by The Hong Kong Polytechnic University are open now, in 1 country. Recruiting first, the newest first:
The Hong Kong Polytechnic University · Sites in Hong Kong
Ages 18+
The Hong Kong Polytechnic University · Sites in Hong Kong
Ages 18+
The Hong Kong Polytechnic University · Sites in Hong Kong
Ages 65+
The Hong Kong Polytechnic University · Sites in Hong Kong
Ages 18+ · Healthy volunteers
The Hong Kong Polytechnic University · Sites in Hong Kong
Ages 60+
By country, each count listing its studies:
Of the 383 Dementia studies recruiting now, 244 (64%) set no upper age limit and 25 (7%) stop at 75 or younger; 16 take children under 18; 164 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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32 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 3 started in 2026.
This study's planned enrollment of 120 is above the median of 90 across 1,759 interventional studies indexed under Dementia.
Median enrollment 80 across the 32 interventional studies. Of the 13 that completed or were terminated, 1 (8%) have results posted.
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The Hong Kong Polytechnic University is the lead sponsor of 681 studies on the registry; 259 are open to participants now.
3 of the studies in Dementia by The Hong Kong Polytechnic University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07019441The Hong Kong Polytechnic UniversityA Daily-Activity-Focused, Strategy-Based Educational Programme for Informal Dementia Carers | 2026-12 |
| NCT07784946The Hong Kong Polytechnic UniversityA Behavioural Sleep Intervention for People With Mild Cognitive Impairment and Mild Dementia | 2027-07 |
| NCT06665243The Hong Kong Polytechnic UniversityHorticultural Activities Among the People with Dementia and Their Family Caregivers | 2027-11-01 |
Add all 3 to your calendar (.ics) → With an account.
Among the 32 studies in Dementia by The Hong Kong Polytechnic University, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Sleep disturbances are common among informal caregivers of people with dementia and can negatively affect their physical and psychological well-being. This randomized controlled trial aims to evaluate the effectiveness of an 8-week telephone-coached sleep bibliotherapy program in improving sleep quality among informal caregivers of people with dementia. Participants will be randomly assigned to either a sleep bibliotherapy intervention group or an educational booklet control group. Outcomes including sleep quality, caregiving appraisal, dysfunctional beliefs about sleep, emotional distress, neuropsychiatric symptoms of care recipients, and quality of life will be assessed at baseline, immediately post-intervention, and 3 months post-intervention.
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.
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.
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.
Behavioral: Telephone-Coached Sleep Bibliotherapy
Participants receive an educational booklet containing general health information and weekly check-in telephone calls. The booklet does not include therapeutic sleep intervention components.
Behavioral: Educational Booklet
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.
Participants receive an educational booklet containing general health information and weekly check-in telephone calls.
Sleep Quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Higher scores indicate poorer sleep quality.
Time frame: Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
Caregiving Appraisal
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).
Time frame: Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
Dysfunctional beliefs and attitudes about sleep
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.
Time frame: Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
Emotional distress
It will be measured with the stress, anxiety, and depression scales (DASS-21).
Time frame: Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
Patient neuropsychiatric symptoms
The Neuropsychiatric Inventory (NPI) will be used to measure neuropsychiatric symptoms. NPI evaluates 12 common neuropsychiatric disturbances in dementia.
Time frame: Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
Dyadic quality of life
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
Time frame: Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention
Plan to share: No
Started Aug 2026 (actual). Primary completion is estimated for Dec 2028, 28 months after the start.
Of 858 non-industry interventional studies with no phase under Dementia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 28 months is above that.
Counting every sponsor, half of 904 studies reached it within 25 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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