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

NCT06506487 | Completed

• 1 other identifier: LL20240509
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Outcome Measures

Primary Outcomes (1)

• Change in Class-Specific Daily Medication Dose

  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.

  12 weeks

Secondary Outcomes (2)

• Change in Behavioral and Psychological Symptoms of Dementia (BPSD)

  12 weeks

• Change in Activities of Daily Living (ADL)

  12 weeks

Other Outcomes (3)

• Change in Cognitive Enhancer Use

  12 weeks

• Change in Traditional Chinese Medicine Use

  12 weeks

• Doll Engagement and Adherence

  12 weeks

Study Arms (2)

Staff-Mediated Doll Therapy plus Routine Nursing Care

EXPERIMENTAL

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.

Behavioral: Doll Therapy

Routine Nursing Care

NO INTERVENTION

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.

Interventions

Doll Therapy BEHAVIORAL

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.

Staff-Mediated Doll Therapy plus Routine Nursing Care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Sias University

Zhengzhou, Henan, 451100, China

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Zhenti Cui

  Social and Preventive Medicine, Malaya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Model Details: 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.

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: July 31, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 3 months to 5 years following article publication
• Access Criteria: Researchers must provide a methodologically sound proposal and obtain appropriate ethics and institutional approvals where required. Access will be subject to review by the study team and the responsible institution, and requestors must sign a data access agreement covering confidentiality, permitted use, and secure storage.

Locations

CN (1)