Neurocognitive DisordersNCT06416514
Personalized Interventions Via Health Portraits in Mild Behavioral Impairment
A study testing Personalized intervention in people with Neurocognitive Disorders, run by Fujian Provincial Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurocognitive Disorders
- What is being tested?
- Personalized intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2024to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Provincial Hospital
Fuzhou, Fujian, 350001
yuanjiao yan, PhD, +8618120826271, yuanjiao1994@126.com
About this study
Official title: Construction and Empirical Study of Personalized Intervention Based on Health Portrait in Mild Behavioral Impairment
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.
Read the 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.
- Conditions
- Neurocognitive Disorders
- Being tested
- Personalized intervention
- Keywords
- Mild behavioral impairment, Older adults, Personalized intervention, Health portrait, Neuropsychiatric symptoms
- Medical subject headings
- Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized interventionOther
Also called Usual care
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Personalized intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately
Secondary outcomes (5)
Sleep condition
The Pittsburgh Sleep Quality Index, developed by Buysse equals in 1989, was used to evaluate the sleep status of the participants over the past month. The Pittsburgh Sleep Quality Index includes seven components: subjective sleep quality, sleep duration, sleep duration, sleep efficiency, sleep disorders, hypnotic drugs, and daytime function, with good internal consistency (Cronbach's α=0.83) and retest reliability (r=0.85). The cumulative score for each component of the Pittsburgh Sleep Quality Index Scale is the total score of the scale, ranging from 0 to 21, with a score of 0 to 3 for each component, with higher scores associated with poorer sleep quality
Measured: The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately
Social participation
The Social Support Rating Scale was used to assess participants' social participation. This study adopted the social support assessment compiled by domestic scholar Xiao Shuiyuan, which has good reliability and validity (Cronbach's α coefficient is 0.83). There are 10 items in the social support evaluation, including objective support, subjective support and social support utilization. The score ranges from 11 to 40 points. The higher the score of each dimension, the higher the degree of social support. It is generally believed that the total score of 20 is poor social support, 20-30 is general social support, and 30-40 is satisfactory social support
Measured: The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately
Dementia conversion rate
The Condensed Mental State Scale, developed by Folstein et al., is increasingly being used to screen patients for dementia, determine the severity of cognitive impairment, and determine dementia transition. The sensitivity and specificity of the concise mental State scale in the screening diagnosis of dementia are 80-90% and 70-80%. The scale covers cognitive areas such as orientation, memory, attention and computation, speech and visuospatial. The Condensed Mental State Scale ranges from 0 to 30 points. Dementia can be graded according to the Condensed Mental State Scale, with mild dementia scoring 21-26, moderate dementia 11-20, and severe dementia 0-10
Measured: The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately
Psychological symptoms
The Neuropsychiatric Scale (NPI) is also a suitable tool for assessing NPS in patients with MBI. The Neuropsychiatric Scale is a scale developed by Cummings et al. to assess NPS in dementia patients, including hallucinations, delusions, agitation/aggression, anxiety, depression, euphoria, loss, disinhibition, abnormal movement, appetite disorders, sleep and nocturnal behavior disorders. The Chinese version of neuropsychiatric scale has good reliability and validity with Cronbach's α coefficient of 0.851, bias coefficient of 0.83, and total retest reliability of 0.86. The neuropsychiatric scale is easy to use and provides a way for semi-structured interviews to distinguish symptoms of inhibition from symptoms of apathy. Neuropsychiatric scale patient scores ranged from 0-144, caregiver pain scores ranged from 0-60, the lower the score the better
Measured: The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately
Behaviour impairment
The Mild Behavioral Impairment checklist (MBI-Checklist) asseses subjects to assess the symptoms and severity of MBI and was developed by ISTAART after the publication of diagnostic criteria for MBI in 2016. The mild behavioral impairment Checklist, filled out by a family member or someone in the know, has five categories, including lack of motivation, emotional incoordination, impulse control disorders, social withdrawal, and perceptual or thinking abnormalities. The sensitivity and specificity of the mild behavioral impairment checklist were 86.96% and 86.00%. The mild behavioral Impairment Checklist scores range from 0 to 102, with the higher the total score, the higher the degree of mild behavioral impairment
Measured: The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start25 Jun 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive DisordersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuanjiao Yan, Fujian Provincial Hospital
- Investigators
- Yuanjiao Yan, PhD, Study director, Shengli clinical medical college of Fujian Medical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416514
- Sponsor's protocol ID
- 2023-177
- Status last verified
- Jul 2024
- First submitted
- 16 Jan 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Empirical Study of Personalized Intervention Based on Health Portrait in Mild Behavioral Impairment
- ClinicalTrials.gov ID
- NCT06416514
- Acronym / sponsor ID
- 2023-177
- Conditions
- Neurocognitive Disorders
- Keywords
- Mild behavioral impairment, Older adults, Personalized intervention, Health portrait, Neuropsychiatric symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 16 May 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with high social participation | Experimental | Other: Personalized interventionPatients 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. |
| Patients with low social participation | Experimental | Other: Personalized interventionIn 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Personalized interventionAlso: Usual carePersonalized 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. | Other | Patients with high social participation, Patients with low social participation |
Primary outcome
General cognitive function
Time frame: The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately
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
5 secondary outcomes
Sleep condition
Time frame: The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately
Social participation
Time frame: The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately
Dementia conversion rate
Time frame: The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately
Psychological symptoms
Time frame: The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately
Behaviour impairment
Time frame: The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
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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.
Yuanjiao Yan, PhD study director
Shengli clinical medical college of Fujian 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 Personalized intervention in people with Neurocognitive Disorders, run by Fujian Provincial Hospital 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 2 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: looking for participants now, as of the sponsor's last update on 18 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shi Yanhong (89-15150947040, Cordelia88@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General cognitive function (time frame: The intervention was conducted in September 2024, and the evaluation time was 0,3 months separately). 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 18 Jul 2024.