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

July 9, 2026 updated by: Zhenti Cui, University of Malaya
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
142

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 451100
        • Sias University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Staff-Mediated Doll Therapy plus Routine Nursing Care
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
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.
No Intervention: Routine Nursing Care
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Class-Specific Daily Medication Dose
Time Frame: 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.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Behavioral and Psychological Symptoms of Dementia (BPSD)
Time Frame: 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.
12 weeks
Change in Activities of Daily Living (ADL)
Time Frame: 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.
12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Cognitive Enhancer Use
Time Frame: 12 weeks
Cognitive enhancer use is evaluated as a secondary/contextual medication outcome over 12 weeks and expressed in donepezil-equivalent daily dose where applicable. Changes are compared between doll therapy plus routine nursing care and routine care alone.
12 weeks
Change in Traditional Chinese Medicine Use
Time Frame: 12 weeks
Traditional Chinese medicine use is summarized as a context-specific composite score incorporating formula complexity, dosage, frequency, and duration. This contextual outcome is evaluated over 12 weeks and compared between doll therapy plus routine nursing care and routine care alone.
12 weeks
Doll Engagement and Adherence
Time Frame: 12 weeks
Within intervention homes, structured session records document doll acceptance, session attendance, resident assent or dissent, and sustained engagement with the doll. Engagement and adherence are summarized descriptively and used for contextual interpretation and per-protocol sensitivity analysis.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Malaya

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhenti Cui, Social and Preventive Medicine, Malaya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LL20240509

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified quantitative analysis-ready data underlying the reported results and analytic code may be shared with qualified researchers on reasonable request. Because the dataset contains potentially identifiable nursing-home clinical information, data will not be posted publicly. The qualitative coding framework may also be available on reasonable request.

IPD Sharing Time Frame

3 months to 5 years following article publication

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings