Dementia
Conditions
Brief summary
This study is a two-phase explanatory sequential mixed-methods study in Chinese residential dementia care. Phase I is a pragmatic 1:1 exploratory pilot cluster randomized trial in six nursing homes in Zhengzhou, China, comparing staff-mediated doll therapy plus routine nursing care with routine nursing care alone among 142 residents with dementia assessed at baseline, 6 weeks, and 12 weeks. Registered primary outcomes are class-specific daily medication-dose trajectories for antipsychotics, anxiolytics, and antidepressants. Secondary and contextual outcomes include behavioral and psychological symptoms of dementia, activities of daily living, cognitive enhancer use, traditional Chinese medicine use, and doll engagement/adherence. Phase II uses semi-structured interviews with staff and family caregivers to explore acceptability, implementation, training needs, cultural fit, and ethical considerations.
Detailed description
Doll therapy is a person-centered, attachment-informed non-pharmacological intervention in which a person living with dementia is offered a lifelike doll and may interact with it by holding, comforting, grooming, or talking to it. This exploratory pilot and feasibility mixed-methods cluster randomized trial evaluates a staff-mediated doll-therapy care package in Chinese nursing homes. Intervention homes receive staff training, a structured introduction to a personal doll, relational engagement during routine care, and ongoing monitoring of resident assent, dissent, distress, and fit. Control homes provide routine nursing care alone. Quantitative assessments are conducted at baseline, 6 weeks, and 12 weeks. Medication-related outcomes are interpreted as indirect health-service and medication-burden signals rather than as direct evidence of prescribing causation. Behavioral, functional, contextual medication, traditional Chinese medicine, and engagement measures are interpreted alongside qualitative interviews with staff and family caregivers to understand implementation, acceptability, cultural fit, and ethical safeguards. Because only six clusters are randomized, the study is intended to generate feasibility information, preliminary effect estimates, and implementation signals rather than definitive clinical-effect evidence.
Interventions
BEHAVIORALDoll Therapy
Staff-mediated doll therapy is a person-centered, attachment-informed non-pharmacological care package in which trained nursing-home staff introduce a lifelike doll respectfully, support resident-led interaction, monitor assent and dissent, and provide continued access to a personal doll during routine care. The intervention included eight planned introductory sessions over approximately 15 days, structured interaction, relational engagement, and implementation within ordinary nursing-home care.
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The intervention was visible in routine care, so residents, direct caregivers, and intervention deliverers were not blinded. Medication outcomes were extracted from medication records by assessors masked to allocation where feasible; caregiver-reported NPI-12 and Barthel ratings could not be fully blinded.
Intervention model description
Pragmatic, parallel-group, 1:1 cluster randomized pilot trial in six nursing homes. The nursing home was the unit of randomization to reduce contamination; three homes were assigned to staff-mediated doll therapy plus routine nursing care and three to routine nursing care alone.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 65 years or older. * Nursing home resident with a documented clinical diagnosis of dementia recorded in the medical or nursing-home record by a qualified physician using DSM-5, ICD-10, ICD-11, or current Chinese clinical guidelines for dementia and cognitive impairment; where the underlying diagnostic criteria were not specified in the record, the site clinician reconfirmed the diagnosis against DSM-5 criteria before enrollment. * Adequate visual capacity to recognize a doll at screening. * Sufficient upper-limb function to hold or caress the doll safely. * Availability of a legally authorized representative able to provide written informed consent. * Resident assent whenever appropriate.
Exclusion criteria
* Acute medical instability. * Severe sensory or physical limitations preventing safe participation. * Severe communication impairment precluding meaningful participation. * Major psychiatric disorders unrelated to dementia. * Resident dissent or refusal when assent was appropriate, or safety concerns that made doll interaction unsuitable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Class-Specific Daily Medication Dose | 12 weeks | This primary outcome assesses class-specific mean daily medication-dose trajectories for antipsychotics, anxiolytics, and antidepressants over 12 weeks. Antipsychotics are expressed as chlorpromazine-equivalent daily dose, anxiolytics as diazepam-equivalent daily dose, and antidepressants using the WHO defined daily dose framework. Changes are compared between doll therapy plus routine nursing care and routine care alone. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Behavioral and Psychological Symptoms of Dementia (BPSD) | 12 weeks | This secondary outcome measure will evaluate the change in behavioral and psychological symptoms of dementia (BPSD) using the Neuropsychiatric Inventory (NPI-12). This inventory includes 12 domains such as delusions, hallucinations, agitation/aggression, depression, anxiety, and others. The scores will be measured and compared between the intervention and control groups. The NPI-12 scores range from 0 to 144, with higher scores indicating more severe symptoms. |
| Change in Activities of Daily Living (ADL) | 12 weeks | This secondary outcome measure will assess the change in activities of daily living (ADL) using the Chinese version of the Barthel Index of ADL. This index measures the functional independence of participants in performing daily activities such as feeding, bathing, dressing, toileting, transferring, and walking. The scores will be measured and compared between the intervention and control groups. The Barthel Index scores range from 0 to 100, with higher scores indicating better functional independence. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORZhenti Cui
Social and Preventive Medicine, Malaya University
Outcome results
None listed