Alzheimer DiseaseNCT06868004
Holistic Nursing Benefits Cognitive and Psychiatric Symptoms in Alzheimer's Patients
A study testing Holistic Nursing in people with Alzheimer Disease, run by The First People's Hospital of Jingzhou at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Holistic Nursing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning
About this study
Official title: Positive Impact of Holistic Nursing on Cognitive Impairment and Psychiatric Symptoms in Patients with Alzheimer's Disease
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.
Read more
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.
- Conditions
- Alzheimer Disease
- Being tested
- Holistic Nursing
- Keywords
- Alzheimer's Disease, Holistic nursing, Psychological state, Cognitive function, Psychiatric symptoms
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holistic NursingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Not described |
| Observation Group | Experimental | Not described Receives: Behavioral: Holistic Nursing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (before intervention) and after 6 months of intervention.
Secondary outcomes (6)
Change in Psychiatric Symptoms Assessed by NPI
Reduction in psychiatric symptoms will be measured using the Neuropsychiatric Inventory (NPI) score. Lower scores will indicate improvements in symptoms such as anxiety, depression, and agitation.
Measured: Baseline (before intervention) and after 6 months of intervention.
Change in Anxiety Levels (SAS Score)
Anxiety levels will be measured using the Self-Rating Anxiety Scale (SAS). The SAS score ranges from 20 to 80, with higher scores indicating greater anxiety severity. A reduction in scores post-intervention will indicate an improvement in anxiety symptoms.
Measured: Baseline (before intervention) and after 6 months of intervention.
Medication Adherence
Patient adherence to prescribed medication will be measured using the Morisky Medication Adherence Scale-8 (MMAS-8). The MMAS-8 score ranges from 0 to 8, with higher scores indicating better adherence to medication regimens.
Measured: Baseline (before intervention) and after 6 months of intervention.
Family Satisfaction
Family satisfaction with nursing care and interventions will be assessed using a validated nursing satisfaction questionnaire. The questionnaire includes a Likert scale ranging from 1 to 5, where higher scores indicate greater satisfaction. The overall satisfaction rate will provide insights into the perceived effectiveness of the intervention from the family's perspective.
Measured: At discharge (approximately within 24 hours of patient discharge).
Change in Cognitive Function Related to Psychiatric Symptoms Assessed by ADAS-cog
Cognitive changes associated with psychiatric symptoms will be measured using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog). Lower scores will indicate reduced cognitive impairment.
Measured: Baseline (before intervention) and after 6 months of intervention.
Change in Depression Levels (SDS Score)
Depression levels will be measured using the Self-Rating Depression Scale (SDS). The SDS score ranges from 25 to 100, with higher scores indicating greater depression severity. A reduction in scores post-intervention will indicate an improvement in depression symptoms.
Measured: Baseline (before intervention) and after 6 months of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Jan 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Jingzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868004
- Sponsor's protocol ID
- 2023199
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40355993
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Impact of Holistic Nursing on Cognitive Impairment and Psychiatric Symptoms in Patients with Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06868004
- Acronym / sponsor ID
- 2023199
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer's Disease, Holistic nursing, Psychological state, Cognitive function, Psychiatric symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- The First People's Hospital of JingzhouUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | – |
| Observation Group | Experimental | Behavioral: Holistic Nursing |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holistic NursingThe 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. | Behavioural | Observation Group |
Primary outcome
Change in Cognitive Function Assessed by MMSE
Time frame: Baseline (before intervention) and after 6 months of intervention.
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.
Change in Cognitive Function Assessed by MoCA
Time frame: Baseline (before intervention) and after 6 months of intervention.
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.
6 secondary outcomes
Change in Psychiatric Symptoms Assessed by NPI
Time frame: Baseline (before intervention) and after 6 months of intervention.
Change in Anxiety Levels (SAS Score)
Time frame: Baseline (before intervention) and after 6 months of intervention.
Medication Adherence
Time frame: Baseline (before intervention) and after 6 months of intervention.
Family Satisfaction
Time frame: At discharge (approximately within 24 hours of patient discharge).
Change in Cognitive Function Related to Psychiatric Symptoms Assessed by ADAS-cog
Time frame: Baseline (before intervention) and after 6 months of intervention.
Change in Depression Levels (SDS Score)
Time frame: Baseline (before intervention) and after 6 months of intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Derived from this study: PubMed 40355993Yu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holistic Nursing in people with Alzheimer Disease, run by The First People's Hospital of Jingzhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive Function Assessed by MMSE (time frame: Baseline (before intervention) and after 6 months of intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06868004, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.