Clinical trial NCT06868004: Holistic Nursing Benefits Cognitive and Psychiatric Symptoms in Alzheimer's Patients
Official title: Positive Impact of Holistic Nursing on Cognitive Impairment and Psychiatric Symptoms in Patients with Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: Alzheimer&amp;#39;s Disease
Holistic nursing
Psychological state
Cognitive function
Psychiatric symptoms
Lead sponsor: The First People's Hospital of Jingzhou
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 105
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Cognitive Function Assessed by MMSE
timeFrame: Baseline (before intervention) and after 6 months of intervention.
measure: Change in Cognitive Function Assessed by MoCA
timeFrame: Baseline (before intervention) and after 6 months of intervention.
Secondary outcomes:
measure: Change in Psychiatric Symptoms Assessed by NPI
timeFrame: Baseline (before intervention) and after 6 months of intervention.
measure: Change in Anxiety Levels (SAS Score)
timeFrame: Baseline (before intervention) and after 6 months of intervention.
measure: Medication Adherence
timeFrame: Baseline (before intervention) and after 6 months of intervention.
measure: Family Satisfaction
timeFrame: At discharge (approximately within 24 hours of patient discharge).
measure: Change in Cognitive Function Related to Psychiatric Symptoms Assessed by ADAS-cog
timeFrame: Baseline (before intervention) and after 6 months of intervention.
measure: Change in Depression Levels (SDS Score)
timeFrame: Baseline (before intervention) and after 6 months of intervention.
Other outcomes:
Locations:
city: Jinzhou
country: China
facility: The First Affiliated Hospital of Jinzhou Medical University
state: Liaoning
Study officials:
References: