Clinical trial NCT06416514: Personalized Interventions Via Health Portraits in Mild Behavioral Impairment
Official title: Construction and Empirical Study of Personalized Intervention Based on Health Portrait in Mild Behavioral Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurocognitive Disorders
Keywords: Mild behavioral impairment
Older adults
Personalized intervention
Health portrait
Neuropsychiatric symptoms
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Combined with the current situation of relevant research at home and abroad, it can be seen that the research in this field still has the following limitations:First, as a population with a high incidence of dementia, there are many studies on the influencing factors of dementia in elderly MBI, but there is heterogeneity in research design and other aspects, and no studies have effectively integrated it. Therefore, determining the risk factors of MBI in the elderly is helpful for effective risk factor management in the early stage of dementia, which is of great significance for delaying the speed of MBI in the elderly and reducing the burden of family and society.Second, most current studies are cross-sectional studies or the development and testing of assessment tools, and few studies pay in-depth attention to the development and change of NPS, ignoring the possibility of reversal of MBI. Further understanding of the natural history of MBI and the influence of demography, environment, lifestyle and other related factors on the occurrence and development of MBI, and understanding the change law of the occurrence and development of MBI are of great importance to find the breakthrough point of early and effective intervention.Third, there is still a lack of management guidelines for MBI, and it is urgent to develop personalized non-drug interventions for MBI patients. "Human-centered" multiple personalized intervention is expected to improve NPS symptoms in MBI patients, reduce the occurrence of dementia, and delay the progression of dementia.Fourth, as an emerging technology, health portrait has made some progress in the management of chronic disease symptoms at home and abroad, but its application in the specific subdivision of chronic disease management in the elderly is still limited. The application of health portrait in the management of NPS symptoms in elderly MBI patients is a new exploration.Therefore, this study raises three research questions: First, what is the current situation of mild behavioral impairment in the elderly? What are the relevant factors? Second, what are the risk factors that affect the outcome of mild behavioral impairment in the elderly? What is the probability of metastasis between different states in elderly patients with mild behavioral impairment? Third, how to build a personalized program for elderly MBI patients in China based on user portraits? How scientific, feasible and safe is it?In view of the above research problems, this study first understood the status quo of mild behavioral impairment in the elderly and explored its related factors; Then, the prediction model of mild behavioral impairment in the elderly was constructed to explore the factors affecting its outcome and its transfer probability. Finally, a personalized intervention system for elderly patients with mild behavioral impairment based on health profiles was developed and tested. The significance of this study is that in the context of the rapid development of population aging, the increasing promotion of the strategy of healthy China and the national strategy of actively coping with population aging, the completion of this study is expected to clarify the development and change mechanism of MBI, provide new ideas and new methods for the management of MBI patients, and also provide new evidence for the prevention and treatment of dementia high-risk groups. This is a low-cost and efficient strategic choice to deal with the aging population and reduce the burden of dementia, and has a good scientific application prospect and practical significance.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: General cognitive function
timeFrame: The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately
Secondary outcomes:
measure: Sleep condition
timeFrame: The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately
measure: Social participation
timeFrame: The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately
measure: Dementia conversion rate
timeFrame: The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately
measure: Psychological symptoms
timeFrame: The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately
measure: Behaviour impairment
timeFrame: The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
Study officials:
affiliation: Shengli clinical medical college of Fujian Medical university
name: Yuanjiao Yan, PhD
role: STUDY_DIRECTOR
References: