Personalized Interventions Via Health Portraits in Mild Behavioral Impairment

NCT06416514 | Recruiting DMC

• 1 other identifier: 2023-177
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of MBI and the probability of progression to dementia are high. Early detection and intervention have important clinical significance to reduce the occurrence of dementia, delay the progression of dementia and promote healthy aging to active aging. The occurrence and development of NPS in MBI patients may be related to genetic and degenerative changes in the central nervous system. The evaluation of MBI patients is mainly based on neuropsychological tests, including NPS and cognitive function assessment. Landmark model is an effective tool for dynamic risk prediction of the progress of MBI. It can make dynamic prediction at different time points according to various existing measurement indicators of an individual and calculate the individual prediction probability, which is one of the best models for studying the outcome of disease at present. The Landmark model is applied to the elderly MBI population to study the influencing factors of normal aging, MBI and dementia and the probability of metastasis, which is a beneficial attempt to further advance the defense line of dementia. Personalized non-drug intervention is the preferred treatment for MBI, which mainly includes cognitive/emotional intervention, sensory stimulation, exercise therapy, etc. Currently, it is recommended to adopt diversified strategies to implement individualized precision treatment programs for patients. The hierarchical and classified health management of elderly MBI patients combined with health portrait technology is helpful to improve management efficiency and better meet the needs of personalized health management for the elderly.

Conditions

Neurocognitive Disorders

Keywords

Mild behavioral impairment; Older adults; Personalized intervention; Health portrait; Neuropsychiatric symptoms

Outcome Measures

Primary Outcomes (1)

• General cognitive function

  The Montreal Cognitive Assessment Scale, developed by Nasreddine in 2004 to assess participants' general cognitive function, covers eight areas of cognitive assessment, including visuospatial and executive function, naming, memory, attention, speech, abstraction, delayed recall, and orientation. The Changsha version of the Montreal Cognitive Assessment Scale was used in this study, and its Cronbach's α coefficient was 0.846, retest reliability was 0.974, and investigator reliability was 0.969. The score of the Montreal Cognitive Assessment Scale ranges from 0 to 30 points. The higher the score, the better the cognitive function of the study subjects. The illiterate group ≤13, the primary school group ≤19, and the junior high school and above group ≤24 can be judged as impaired cognitive function to correct the bias caused by education level

  The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately

Secondary Outcomes (5)

• Sleep condition

  The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately

• Social participation

  The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately

• Dementia conversion rate

  The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately

• Psychological symptoms

  The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately

• Behaviour impairment

  The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately

Study Arms (2)

Patients with high social participation

EXPERIMENTAL

Patients with high social participation were more active in health management and monitoring due to their high social participation. NPS symptoms were monitored regularly for patients in the different groups, and personalized interventions were developed according to the development of NPS symptoms and patient preferences.

Other: Personalized intervention

Patients with low social participation

EXPERIMENTAL

In the low social participation group, due to the low social participation of patients, their initiative to participate in health management and monitoring is also low. For the patients in the reorganized group, their self-confidence and enthusiasm to participate in activities are first enhanced through health education and health popularization, and NPS symptoms are regularly monitored, and personalized intervention measures are formulated according to the development of NPS symptoms and patient preferences.

Other: Personalized intervention

Interventions

Personalized intervention OTHER

Personalized intervention means implementing multi-component non-pharmacological interventions based on different health profiles，such as art therapy, exercise therapy, cognitive therapy and other monotherapies. Usual care means care as routine.

Also known as: Usual care

Patients with high social participation; Patients with low social participation

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the ISTAART diagnostic criteria for MBI;
• Age ≥60 years old;
• No obvious visual or hearing impairment;
• Have the ability of language communication, can complete the scale assessment.

You may not qualify if:

• Patients with severe physical diseases and unable to complete cognitive function screening;
• Patients with other neurological diseases and serious medical diseases that can cause brain dysfunction.

Sponsors & Collaborators

• Fujian Provincial Hospital: lead

Study Sites (1)

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Yuanjiao Yan, PhD

  Shengli clinical medical college of Fujian Medical university

  STUDY DIRECTOR

Central Study Contacts

Shi Yanhong

CONTACT

89-15150947040; Cordelia88@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: May 16, 2024
• Study Start: June 25, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: July 18, 2024

Record last verified: 2024-07

Locations

CN (1)