Holistic Nursing Benefits Cognitive and Psychiatric Symptoms in Alzheimer's Patients

NCT ID: NCT06868004

Last Updated: 2025-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Observation Group

Group Type EXPERIMENTAL

Holistic Nursing

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Holistic Nursing

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The First People's Hospital of Jingzhou

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40355993 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023199

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.