Alzheimer DiseaseNCT06473220
Evaluation of the Effectiveness of Narrative Nursing
A study testing Narrative nursing in people with Alzheimer Disease and Narrative, run by Nanjing Medical University at 1 site in China.
Trial summary
To explore the effects of narrative nursing on mental state, life ability and emotion of patients with Alzheimer's disease (AD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease, Narrative, Depression, Anxiety
- What is being tested?
- Narrative nursing
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 30 Oct 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Alzheimer's Disease.
- Forgetting is the main cognitive impairment;.
- The patient has basic language communication ability.
- Patients were treated with the same regimen.
Who cannot join
- Patients with other common neurological and mental disorders (depression, psychosis, vascular cognitive impairment).
- Patients with heart, liver and other vital organ dysfunction.
- Patients with severe cardiovascular disease.
- Patients with severe physical disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of Narrative Nursing in Patients With Alzheimer's Disease
To explore the effects of narrative nursing on mental state, life ability and emotion of patients with Alzheimer's disease (AD).
Read the detailed description
There is no effective clinical treatment, mainly through taking Western drugs to control the Alzheimer's disease, but the treatment cycle is long, the cost of drugs is high, and the patient's family nee care, resulds long-termting in a huge economic and psychological burden on the patient and family recipients. Narrative nursing is an intervention mode of psychological nursing.In practice, narrative nursing can guide patients to actively organize experiences into various events with certain practical significance, attach importance to personal feelings and experiences, promote the psychological growth of patients and promote the generation of upward motivation.
- Conditions
- Alzheimer Disease, Narrative, Depression, Anxiety
- Being tested
- Narrative nursing
- Medical subject headings
- Alzheimer Disease, Narration, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative nursingBehavioural
Narrative nursing is an intervention mode of psychological nursing.
| Study group | Role | What they receive |
|---|---|---|
| Reference group | Other | The reference group carried out routine nursing, that is, the most appropriate intervention measures were properly formulated according to the actual condition degree and various levels of physical fitness of the patients, and the patients were urged to take drugs according to the doctor's advice every day. Nurses should conduct oral health promotion for patients; Administering medication and a daily healthy diet regimen; Patients with orientation and language communication disorders were given nursing care step by step. Continuous care for 2 months. Receives: Behavioral: Narrative nursing |
| Study group | Experimental | The research group cooperated with the implementation of narrative nursing. The detailed measures are as follows: ① Establish a narrative nursing special group. ② Narrative data collection. ③ Pay attention to the scientific evaluation of narrative content. ④ Edit the narrative reasonably. ⑤ Strengthen interview intervention. Continuous care for 2 months. Receives: Behavioral: Narrative nursing |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMSE sore
The simple mental state Intelligence Scale (MMSE) was used to evaluate the mental state of the patients before and after the nursing intervention. The scale was mainly composed of 5 dimensions, namely orientation ability, recall ability, memory ability, attention and calculation ability, and language ability, and contained a total of 30 items. The total score was 0-30 points, the higher the score, the better the mental state of the patients.
Measured: After 1, 2 and 4 weeks after hospitalization
ESCA score
The self-care ability measurement (ESCA) scale was used to evaluate the practical self-care ability of patients in the two groups before and after nursing intervention. The scale was mainly composed of four dimensions: self-concept, health knowledge mastery level, sense of responsibility, and self-care practical skills, and contained 43 items with a total score of 0-172. It shows that the actual ability of self-care is better.
Measured: After 1, 2 and 4 weeks after hospitalization
HAMD score
The score consisted of 17 items, including self-awareness, work and interest, gastrointestinal symptoms, weight loss, hypochondriasis, sleep difficulty, etc. The total score < 7 was considered normal, 7 to 17 divided into possible depression syndrome, > 17-24 were classified as having depression, and> 24 were classified as major depression.
Measured: After 1, 2 and 4 weeks after hospitalization
HAMA score
The score includes two dimensions: spirituality and physicality, with a total of 14 items, including gastrointestinal and digestive symptoms, depressive mood, sensory system symptoms, behavioral manifestations when communicating with others, somatic anxiety, cognitive function, etc. The total score is > 28, which is classified as severe anxiety, 21 to 28 grades are anxious, 14 to < 21 is classified as anxiety, 7 to < 14 scores may have anxiety, and <7 is considered normal.
Measured: After 1, 2 and 4 weeks after hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Oct 2022
- Primary completion1 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Honglian, Nanjing Medical University
- Investigators
- Huang C ying, Bachelor, Study chair, The Affiliated Brain Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473220
- Sponsor's protocol ID
- 310638478
- Status last verified
- Jun 2024
- First submitted
- 18 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Respect privacy rights.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Narrative Nursing in Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06473220
- Acronym / sponsor ID
- 310638478
- Conditions
- Alzheimer Disease, Narrative, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 25 Jun 2024 (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.
To explore the effects of narrative nursing on mental state, life ability and emotion of patients with Alzheimer's disease (AD).
Detailed description
There is no effective clinical treatment, mainly through taking Western drugs to control the Alzheimer's disease, but the treatment cycle is long, the cost of drugs is high, and the patient's family nee care, resulds long-termting in a huge economic and psychological burden on the patient and family recipients. Narrative nursing is an intervention mode of psychological nursing.In practice, narrative nursing can guide patients to actively organize experiences into various events with certain practical significance, attach importance to personal feelings and experiences, promote the psychological growth of patients and promote the generation of upward motivation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference group | Other | Behavioral: Narrative nursingThe reference group carried out routine nursing, that is, the most appropriate intervention measures were properly formulated according to the actual condition degree and various levels of physical fitness of the patients, and the patients were urged to take drugs according to the doctor's advice every day. Nurses should conduct oral health promotion for patients; Administering medication and a daily healthy diet regimen; Patients with orientation and language communication disorders were given nursing care step by step. Continuous care for 2 months. |
| Study group | Experimental | Behavioral: Narrative nursingThe research group cooperated with the implementation of narrative nursing. The detailed measures are as follows: ① Establish a narrative nursing special group. ② Narrative data collection. ③ Pay attention to the scientific evaluation of narrative content. ④ Edit the narrative reasonably. ⑤ Strengthen interview intervention. Continuous care for 2 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of Alzheimer's Disease.
- Forgetting is the main cognitive impairment;.
- The patient has basic language communication ability.
- Patients were treated with the same regimen.
Key exclusion criteria (4 listed)
- Patients with other common neurological and mental disorders (depression, psychosis, vascular cognitive impairment).
- Patients with heart, liver and other vital organ dysfunction.
- Patients with severe cardiovascular disease.
- Patients with severe physical disorders.
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 |
|---|---|---|
| Narrative nursingNarrative nursing is an intervention mode of psychological nursing. | Behavioural | Reference group, Study group |
Primary outcome
MMSE sore
Time frame: After 1, 2 and 4 weeks after hospitalization
The simple mental state Intelligence Scale (MMSE) was used to evaluate the mental state of the patients before and after the nursing intervention. The scale was mainly composed of 5 dimensions, namely orientation ability, recall ability, memory ability, attention and calculation ability, and language ability, and contained a total of 30 items. The total score was 0-30 points, the higher the score, the better the mental state of the patients.
ESCA score
Time frame: After 1, 2 and 4 weeks after hospitalization
The self-care ability measurement (ESCA) scale was used to evaluate the practical self-care ability of patients in the two groups before and after nursing intervention. The scale was mainly composed of four dimensions: self-concept, health knowledge mastery level, sense of responsibility, and self-care practical skills, and contained 43 items with a total score of 0-172. It shows that the actual ability of self-care is better.
HAMD score
Time frame: After 1, 2 and 4 weeks after hospitalization
The score consisted of 17 items, including self-awareness, work and interest, gastrointestinal symptoms, weight loss, hypochondriasis, sleep difficulty, etc. The total score < 7 was considered normal, 7 to 17 divided into possible depression syndrome, > 17-24 were classified as having depression, and> 24 were classified as major depression.
HAMA score
Time frame: After 1, 2 and 4 weeks after hospitalization
The score includes two dimensions: spirituality and physicality, with a total of 14 items, including gastrointestinal and digestive symptoms, depressive mood, sensory system symptoms, behavioral manifestations when communicating with others, somatic anxiety, cognitive function, etc. The total score is > 28, which is classified as severe anxiety, 21 to 28 grades are anxious, 14 to < 21 is classified as anxiety, 7 to < 14 scores may have anxiety, and <7 is considered normal.
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 25 Jun 2024.
- Individual participant dataSharing planned: No. Respect privacy rights.
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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.
Huang C ying, Bachelor study chair
The Affiliated Brain Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative nursing in people with Alzheimer Disease and Narrative, run by Nanjing Medical University 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 4 inclusion and 4 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 25 Jun 2024. 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?
MMSE sore (time frame: After 1, 2 and 4 weeks after hospitalization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2024.