NCT06473220

Brief Summary

To explore the effects of narrative nursing on mental state, life ability and emotion of patients with Alzheimer's disease (AD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

June 18, 2024

Last Update Submit

June 23, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    After 1, 2 and 4 weeks after hospitalization

Study Arms (2)

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.

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.

Behavioral: Narrative nursing

Interventions

Narrative nursing is an intervention mode of psychological nursing.

Reference groupStudy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulou District

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Alzheimer DiseaseNarrationDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCommunicationBehaviorBehavioral Symptoms

Study Officials

  • Huang C ying, Bachelor

    The Affiliated Brain Hospital of Nanjing Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 18, 2024

First Posted

June 25, 2024

Study Start

October 1, 2022

Primary Completion

October 1, 2023

Study Completion

October 30, 2023

Last Updated

June 25, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Respect privacy rights.

Locations