Effects of Doll Therapy on Apathy and Activities of Daily Living Initiation Deficits in Older Adults With Dementia
Effects of Doll Therapy on Apathy and Activities of Daily Living Initiation Deficits in Older Adults With Dementia: a Randomized Controlled Trial
Dementia is a major health challenge associated with population aging. As dementia progresses, patients often experience a decline in their ability to perform basic activities of daily living (BADL), such as dressing and personal hygiene, leading to increased dependence on caregivers. Apathy, characterized by reduced motivation, interest, and initiative, is a common symptom of dementia and may contribute to difficulties in initiating daily activities.
Doll therapy is a non-pharmacological intervention that involves guided interaction with dolls to promote emotional engagement, motivation, and participation in activities. Previous studies suggest that doll therapy may help alleviate apathy and improve behavioral symptoms in patients with dementia. However, its effects on the initiation of basic daily activities remain unclear.
This study aims to evaluate the effectiveness of doll therapy in improving apathy and basic activities of daily living among older adults with dementia. Participants will be randomly assigned to either a doll therapy group or a usual care group. The intervention will last for 2 weeks, and outcomes will be assessed at baseline, Week 2 (end of intervention), and Week 4 (follow-up).
The primary outcome is the severity of apathy. Secondary outcomes include basic activities of daily living, quality of life, and neuropsychiatric symptoms.
The study hypothesizes that doll therapy will reduce apathy and improve the ability to initiate and perform basic daily activities in older adults with dementia compared with usual care.
Przegląd badań
Szczegółowy opis
Background
Dementia is a progressive condition characterized by cognitive impairment, neuropsychiatric symptoms, and declining functional independence. Impairment in basic activities of daily living (BADL), particularly dressing and personal hygiene, represents a major challenge in dementia care. Such impairment may result not only from cognitive and physical limitations but also from apathy-related difficulties in initiating goal-directed activities.
Apathy is characterized by diminished motivation, reduced initiative, and decreased engagement in purposeful activities. It is commonly observed in patients with dementia and may contribute to increasing dependence on caregivers. Interventions targeting apathy may therefore have potential benefits for maintaining daily functioning and reducing care dependency.
Doll therapy is an emerging non-pharmacological intervention that provides sensory stimulation, emotional engagement, and opportunities for social interaction. Existing evidence suggests potential benefits for behavioral and psychological symptoms of dementia. Nevertheless, evidence regarding its effects on apathy and BADL initiation deficits remains limited.
Study Objectives
The primary objective of this study is to evaluate the effectiveness of doll therapy in reducing apathy among older adults with dementia. The secondary objective is to investigate whether doll therapy improves basic activities of daily living, particularly difficulties in initiating daily activities, as well as quality of life and neuropsychiatric symptoms.
Study Design and Procedures
This study is a randomized controlled trial with an assessor-blinded, parallel-group design. Eligible participants will be randomly allocated to either the intervention group or the control group using stratified permuted block randomization.
Participants in the intervention group will receive doll therapy in addition to usual care. The intervention will be delivered three times per week, with each session lasting approximately 30 minutes, over a 2-week period. The control group will receive usual care without doll therapy.
Outcome assessments will be conducted at three time points: baseline, Week 2 (immediately after the intervention), and Week 4 (2 weeks after completion of the intervention). Outcome assessors will remain unaware of participants' group assignments.
Expected Contribution
This study aims to provide evidence regarding the potential effectiveness of doll therapy in reducing apathy and improving daily functioning among older adults with dementia. The findings may inform the development of practical, low-cost, non-pharmacological interventions for dementia care.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Xinyu Zhang
- Numer telefonu: 86+136-5229-6193
- E-mail: zxy0206cc@163.com
Lokalizacje studiów
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Guangzhou
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Guangdong, Guangzhou, Chiny, 510000
- Rekrutacyjny
- Guangzhou Geriatric Hospital
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Kontakt:
- Guangzhou Geriatric Hospital
- Numer telefonu: +862087412484
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Aged 60 years or older.
- Diagnosed with Alzheimer's disease or other types of dementia according to the International Classification of Diseases, 10th Revision (ICD-10), or with major neurocognitive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- Hospitalization duration exceeding 4 weeks.
- Apathy Evaluation Scale-Informant Version (AES-I) score ≥33.
- Not participating in any other clinical research trials.
- Voluntary participation with written informed consent provided by the participant or their legally authorized representative.
Exclusion Criteria:
- Explicit refusal to interact with dolls.
- Severe uncorrected hearing or visual impairment.
- Uncontrolled severe behavioral and psychological symptoms (e.g., delusions or aggressive behavior) or a primary psychiatric disorder (e.g., schizophrenia or bipolar disorder).
- Comorbid conditions that may impair the ability to independently perform personal hygiene activities, such as hemiplegia, paralysis, joint or skeletal disorders, or Parkinson's disease.
- Presence of a terminal illness.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Doll Therapy Group
Participants in the experimental group will receive doll therapy in addition to usual care. Doll therapy will be administered three times per week, with each session lasting approximately 30 minutes, over a 2-week period. The intervention will involve guided interaction with therapeutic dolls to promote emotional engagement, motivation, and participation in activities of daily living. |
Doll therapy is a non-pharmacological behavioral intervention involving guided interaction with therapeutic dolls. Trained personnel will facilitate interactions to promote emotional engagement, motivation, and participation in daily activities. The intervention will be delivered three times per week, with each session lasting approximately 30 minutes, over a 2-week period, in addition to usual care. |
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Brak interwencji: Usual Care Group
Participants in the control group will receive usual care according to standard hospital nursing practices. Usual care includes routine medical treatment, nursing care, and assistance with basic activities of daily living as needed. No additional structured intervention or doll therapy will be administered as part of the study. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Apathy Evaluation Scale-Informant Version (AES-I) Total Score
Ramy czasowe: At baseline, Week 2 (end of intervention), and Week 4 (follow-up).
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Apathy will be assessed using the Apathy Evaluation Scale-Informant Version (AES-I), an 18-item informant-rated scale designed to evaluate apathy in patients with dementia. Each item is rated on a 4-point Likert scale, yielding a total score ranging from 18 to 72. Higher scores indicate greater severity of apathy. |
At baseline, Week 2 (end of intervention), and Week 4 (follow-up).
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Basic Activities of Daily Living Assessment for Patients with Cognitive Impairment (C-BADL) Score
Ramy czasowe: At baseline, Week 2 (end of intervention), and Week 4 (follow-up).
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Basic activities of daily living (BADL) will be assessed using the Cognitive Impairment-Basic Activities of Daily Living (C-BADL) assessment. Functional limitations are classified into eight phenotypes: independence (no deficits), initiation deficits (inability to independently initiate a task or recognize the need to perform it), planning deficits (failure to prepare necessary items before performing a task), organizational deficits (difficulty sequencing actions logically or monitoring task performance), partial execution deficits (requiring minimal physical assistance), severe execution deficits (requiring moderate physical assistance), complete inability (requiring full assistance), and resistance to care |
At baseline, Week 2 (end of intervention), and Week 4 (follow-up).
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Quality of Life in Alzheimer's Disease (QOL-AD) Score
Ramy czasowe: At baseline, Week 2 (end of intervention), and Week 4 (follow-up).
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Quality of life will be assessed using the Quality of Life in Alzheimer's Disease (QOL-AD) scale. The scale consists of 13 items covering physical health, energy, mood, living situation, memory, family relationships, marital relationship, friendships, overall self-perception, ability to perform household activities, ability to enjoy leisure activities, financial situation, and overall quality of life. Each item is rated on a 4-point scale. Higher scores indicate better quality of life. |
At baseline, Week 2 (end of intervention), and Week 4 (follow-up).
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Neuropsychiatric Inventory Questionnaire (NPI-Q) Total Severity Score
Ramy czasowe: At baseline, Week 2 (end of intervention), and Week 4 (follow-up).
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The Neuropsychiatric Inventory Questionnaire (NPI-Q) assesses 12 neuropsychiatric symptoms in patients with dementia. Each symptom is evaluated based on its presence or absence and, if present, its severity. Higher scores indicate greater severity of neuropsychiatric symptoms. |
At baseline, Week 2 (end of intervention), and Week 4 (follow-up).
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 20260801
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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