Holistic Nursing Benefits Cognitive and Psychiatric Symptoms in Alzheimer's Patients
Positive Impact of Holistic Nursing on Cognitive Impairment and Psychiatric Symptoms in Patients with Alzheimer's Disease
1 other identifier
interventional
105
1 country
1
Brief Summary
This clinical study aims to evaluate the effects of a holistic nursing (HN) intervention on cognitive function, psychological well-being, and overall health outcomes in patients with Alzheimer's disease (AD). AD is a progressive neurodegenerative disorder characterized by cognitive decline and behavioral changes, significantly impacting patients' quality of life and increasing the burden on caregivers. Conventional treatment primarily involves pharmacological interventions, but non-pharmacological approaches, such as specialized nursing care, have shown potential in improving patient outcomes. This study prospectively enrolled 105 AD patients admitted to our hospital between January 2023 and January 2024. Patients were divided into two groups based on admission periods: the control group (n=58) received standard care, while the observation group (n=47) received HN in addition to standard care. The HN intervention was implemented based on established guidelines for older adults with cognitive impairment and consisted of five key components: psychological support, cognitive stimulation, memory enhancement, self-care training, and environmental optimization. The study assessed cognitive function, psychiatric symptoms, anxiety, and depression levels before and after the intervention using validated scales, including the Mini-Mental State Examination (MMSE), Neuropsychiatric Inventory (NPI), Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog), Montreal Cognitive Assessment (MoCA), and Self-rating Anxiety/Depression Scales (SAS/SDS). Additionally, blood biomarkers related to neurological function, such as dopamine, acetylcholine, serotonin, γ-aminobutyric acid, S100β, homocysteine, and interleukin-1β, were measured. Patient compliance, safety outcomes, and family satisfaction with the nursing intervention were also evaluated. The findings of this study may provide evidence supporting the integration of HN as a complementary approach in AD management, potentially improving cognitive function, reducing psychiatric symptoms, and enhancing overall patient well-being.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable alzheimer-disease
Started Jan 2023
Shorter than P25 for not_applicable alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2024
CompletedFirst Submitted
Initial submission to the registry
March 5, 2025
CompletedFirst Posted
Study publicly available on registry
March 10, 2025
CompletedMarch 10, 2025
March 1, 2025
1.1 years
March 5, 2025
March 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Cognitive Function Assessed by MMSE
The improvement in cognitive function will be measured using the Mini-Mental State Examination (MMSE) score. Cognitive changes will be evaluated pre- and post-intervention to assess the effectiveness of the Holistic Nursing intervention.
Baseline (before intervention) and after 6 months of intervention.
Change in Cognitive Function Assessed by MoCA
The improvement in cognitive function will be measured using the Montreal Cognitive Assessment (MoCA) score. Cognitive changes will be evaluated pre- and post-intervention to assess the effectiveness of the Holistic Nursing intervention.
Baseline (before intervention) and after 6 months of intervention.
Secondary Outcomes (6)
Change in Psychiatric Symptoms Assessed by NPI
Baseline (before intervention) and after 6 months of intervention.
Change in Anxiety Levels (SAS Score)
Baseline (before intervention) and after 6 months of intervention.
Medication Adherence
Baseline (before intervention) and after 6 months of intervention.
Family Satisfaction
At discharge (approximately within 24 hours of patient discharge).
Change in Cognitive Function Related to Psychiatric Symptoms Assessed by ADAS-cog
Baseline (before intervention) and after 6 months of intervention.
- +1 more secondary outcomes
Study Arms (2)
Control Group
NO INTERVENTIONObservation Group
EXPERIMENTALInterventions
The intervention in this study is based on Holistic Nursing (HN) for patients with Alzheimer's Disease (AD). It involves a comprehensive approach including psychological support, cognitive rehabilitation, memory enhancement, self-care training, and environmental modifications. Psychological interventions focus on personalized communication and emotional support, aiming to reduce negative emotions and improve trust in the healthcare team. Cognitive interventions include activities like painting, card recognition, and storytelling to enhance cognitive function. Memory interventions use personalized memory aids, and self-care interventions aim to improve daily living skills. The ward environment is adjusted to promote safety and comfort. This multi-faceted approach is designed to improve cognitive function, self-care abilities, and emotional well-being in AD patients.
Eligibility Criteria
You may qualify if:
- Diagnosed with Alzheimer's Disease (AD) according to clinical and neuroimaging evidence.
- Aged between 60 to 80 years.
- Mild-to-moderate disease severity, with a Mini-Mental State Examination (MMSE) score ranging from 10 to 24.
- Adequate cognitive and functional capacity to complete questionnaires and follow the intervention protocol.
- Ability to communicate and comprehend instructions.
- Availability of comprehensive medical records.
- Informed consent obtained from the patient or their legal guardian.
You may not qualify if:
- History of intracranial surgery or major brain trauma.
- Coexisting psychiatric disorders or severe mental illnesses.
- Significant visual, auditory, language, or motor impairments that would hinder participation in the study.
- Severe organ dysfunction that could interfere with study participation or safety.
- Comorbid autoimmune diseases or severe malignancies.
- Participants who have received experimental treatments or clinical trials within the last 3 months.
- Pregnant or breastfeeding women.
- Individuals with a history of substance abuse or dependency.
- Participants with other medical conditions that, in the opinion of the investigator, would compromise participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, China
Related Publications (1)
Yu J, Zhu L, Song Y, Shi B, Zhou X. Positive Impact of Holistic Nursing on Cognitive Impairment and Psychiatric Symptoms in Patients With Alzheimer's Disease. Actas Esp Psiquiatr. 2025 May;53(3):586-597. doi: 10.62641/aep.v53i3.1948.
PMID: 40355993DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2025
First Posted
March 10, 2025
Study Start
January 1, 2023
Primary Completion
January 31, 2024
Study Completion
January 31, 2024
Last Updated
March 10, 2025
Record last verified: 2025-03