Clinical trial NCT06506487: Effectiveness of Doll Therapy in People With Dementia
Official title: Effectiveness of Doll Therapy in People With Dementia: A Mixed Method Research Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dementia
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 142
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to evaluate the effectiveness of doll therapy in reducing the daily dose of medications (DDM), behavioral and psychological symptoms of dementia (BPSD), and improving the activities of daily living (ADL) in people living with dementia (PLwD) in residential care facilities in China. The study employs a cluster randomized controlled trial design, involving 142 participants from six nursing homes, divided into an intervention group receiving doll therapy plus routine nursing care and a control group receiving routine nursing care alone. Additionally, the study will explore the experiences and perceptions of staff and family caregivers through qualitative research methods to provide a comprehensive understanding of the intervention's impact.

Detailed description: Doll therapy, recognized as a non-pharmacological intervention, involves providing lifelike baby dolls to individuals with dementia to elicit positive emotional responses and behaviors. Despite its potential benefits, evidence supporting its efficacy and acceptability remains limited and inconclusive. This mixed-method research study will conduct a cluster randomized controlled trial to systematically evaluate the effectiveness of doll therapy in reducing the daily dose of medications, mitigating behavioral and psychological symptoms, and enhancing daily living activities among Chinese dementia patients in residential care settings. The trial will involve 142 participants from six nursing homes, randomly assigned to either the intervention group (doll therapy plus routine care) or the control group (routine care only). Quantitative outcomes will be measured using standardized scales for medication use, BPSD, and ADL. In parallel, qualitative data will be collected through interviews with staff and family caregivers to gain insights into their experiences and perceptions of doll therapy. The findings are anticipated to inform best practice guidelines for implementing doll therapy in dementia care.

Eligibility criteria: Inclusion Criteria:

* Participants must be at least 65 years old.
* Documented diagnosis of dementia.
* Sufficient manual dexterity to hold or caress a doll.
* Sufficient visual acuity to recognize a doll.
* Must have legal family members or next of kin to sign the consent form.

Exclusion Criteria:

* Individuals with mild dementia who do not accept the doll after two attempts.
* Participants who accept the doll but leave it within two weeks.
* Individuals without the capacity to give informed consent and without a legal representative to provide consent on their behalf.

Primary outcomes:
measure: Change in Daily Dose of Medication (DDM)
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Behavioral and Psychological Symptoms of Dementia (BPSD)
timeFrame: 12 weeks
measure: Change in Activities of Daily Living (ADL)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Sias University
state: Henan
Study officials:
affiliation: Social and Preventive Medicine, Malaya University
name: Zhenti Cui
role: PRINCIPAL_INVESTIGATOR
References: