Exploratory Evaluation of Staff-Mediated Doll Therapy in Chinese Residential Dementia Care: A Mixed-Methods Cluster Randomized Pilot Trial

University of Malaya

Status: Completed

Conditions: Dementia

Treatments: Behavioral: Doll Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06506487

LL20240509

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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142 participants in 2 patient groups

Staff-Mediated Doll Therapy plus Routine Nursing Care

Experimental group

Description:

Residents in intervention homes received routine nursing care plus a staff-mediated doll-therapy care package. The package included staff training, a structured doll-therapy introduction with eight planned sessions over approximately 15 days, continued access to a personal doll during routine care, structured interaction and relational engagement, and ongoing monitoring of resident assent, dissent, distress, and fit.

Treatment:

Behavioral: Doll Therapy

Routine Nursing Care

No Intervention group

Description:

Residents in control homes received routine nursing care alone. Control homes did not receive study-provided dolls or structured doll-therapy training during the study period.