MedTrace Logo

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

NCT06506487 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2026-07-13

No results posted yet for this study

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

Interventions

BEHAVIORAL

Doll 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 & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Zhenti Cui · Social and Preventive Medicine, Malaya University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06506487 on ClinicalTrials.gov